COMMENTARY
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David P. Herzog, PhD, is senior vice president, instrument systems division, at Diagnostic Products Corp. (Los Angeles). He can be reached at dherzog@dpconline.com.
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Lab Automation Technology Today
During the past 15 years, clinical laboratories have seen substantial growth in testing volumes. However, their access to qualified personnel and capital has not kept pace with such growth. Nearly all labs in the United States and the European Union today are experiencing difficulties in hiring qualified medical technologists. They are also faced with constrained budgets and customer demands for faster turnaround times.
IVD manufacturers have responded to the labs’ needs for greater productivity and throughput gains by focusing on two areas: higher-powered analyzers and more-powerful software to manage the automation systems. While both areas are steps in the right direction, they have yet to achieve their full potential.
To meet the labs’ increasing test-volume requirements with today’s testing technologies, analyzer size has grown substantially. Responding to the labs’ growing needs to reduce labor, IVD manufactures have developed systems with greater analytical power which consolidate testing onto fewer platforms and decrease the need to move samples in and out of the instrument. While such analyzers have been effective in reducing labor needs, they came at the cost of space and flexibility. Some instruments have footprints the size of a small room (i.e., greater than 60 sq ft) and still require additional space for operator access, maintenance, and repairs.
The growing size of analyzers as a result of the labs’ higher throughput needs has been compounded by IVD manufacturers developing instruments that provide analyses using both standard chemical methods and immunoassay technologies. By looking for solutions to minimize labor further, today’s total lab automation systems integrate multiple analyzers, automate sample preparation, and facilitate sample retrieval when additional testing is required. The resulting systems often require labs to spend more than $1 million on complex, rigid automation systems to achieve the much needed productivity improvements. Manufacturers are reaching the limits of current analysis technologies as high-volume instruments have become too large to fit into some labs.
In addition, the growth in complexity and physical size of analyzers and automation systems has required IVD manufacturers to design higher levels of embedded instrument intelligence for performance monitoring. Many analyzers contain sophisticated sensors and software that manage every step of sample processing, ensuring it is carried out with quality and precision. Such systems give labs and manufacturers new opportunities to access a wealth of real-time sample and instrument data that the automation software may use to efficiently manage the testing process.
However, due to legacy systems and limited efforts in system integration, most of the automation software on the market today is complex and difficult to use. Lab technologists often must use multiple screens and workstations to access test and instrument data. Software commands are complex and multistep, even for basic lab processes such as the review and release of test results. While today’s analyzers can deliver growing amounts of real-time instrument and test data, automation software has not caught up to translate the data into effective lab management tools.
Instrumentation bloat and software complexity have limited the gains that labs have seen from automation. These issues, though, are undergoing change.
Smaller, More-Flexible Instruments
Despite the limitations of today’s automation systems, labs continue to look for new solutions. Fueled by growing community testing programs, lab consolidation, and a diminishing labor pool, labs are asking for greater productivity from their analyzers. They can no longer afford to run the bulk of their workload manually or on instruments that merely mechanize the reading steps of the analysis.
IVD manufacturers have responded by developing larger systems with larger footprints, higher costs, and limited flexibility. This approach has become ineffective, and manufacturers are approaching the limits of improvements using the current technologies. Achieving higher throughput by enlarging capacities, replicating instrument resources, increasing the size of the analyzers, and consolidating testing is facing the very real and practical physical constraints of lab space availability and lab budgets.
The next generation of analyzers will address the size issue by adopting emerging trends in microtechnology. New technologies such as microfluidics will enable the development of consumables that are much smaller per test unit and will accomplish functionality that is currently achieved by hardware (e.g., pumps, fittings, manifolds, tubing). IVD manufacturers will develop new detection and separation schemes that complement microtechnologies by providing precision and sensitivity of analysis in an economical fashion. Manufacturers will also develop and improve microfabrication techniques to support such goals.
Working with small total reaction volumes (e.g., 100 nl–50 µl), such analyzers will operate with smaller samples, potentially reducing the amount of blood drawn from patients. More importantly, in the future, the mechanism of sample preparation, sorting, and retrieval will be more cost-effective and offer greater flexibility than current solutions. The smaller lab automation systems will be flexible, offering labs the choice of targeted solutions that provide the greatest reductions in skilled labor while minimizing the costs of additional instrumentation. Labs will also have the option of selecting the automation solutions that best meet their unique needs.
The clinical laboratory will again be equipped with physically smaller analyzers and flexible lab automation, while having productivity equal to or greater than today’s large analyzers.
Powerful, Easy-to-Use Software
Automation software limitations slow down lab processes and do not allow labs to realize the analyzer’s test-volume potential. For example, automation software that does not allow any test results to be released until the slowest test has been completed limits productivity gains from a multi-million-dollar investment. Staff savings are constrained by software that requires lab personnel to walk around the lab and view screens on multiple workstations in order to manage an automation system.
The next generation of lab automation software will move away from today’s fragmented, complex systems by integrating all aspects of lab management, from sample logistics to results management, archiving, and retrieval. Access to the laboratory information system (LIS) and all lab processes will go through a centralized control function. Labs will achieve productivity gains by consolidating data and instrument management, and not requiring lab personnel to monitor and manage various data feeds on multiple screens. This emerging functionality may enable a staff of fewer than five technologists to manage a lab delivering millions of tests per year.
Laboratory demands will drive this software trend. Lab managers and their personnel are increasingly frustrated by automation software that has not caught up with the capabilities of the analyzers, and cannot provide access to and management of the lab data. A survey by Diagnostic Products Corp. (DPC; Los Angeles) found that many labs believe their automation software is several generations behind the functionality of the instruments.
In addition, labs are aware of the power of the Internet and are increasingly using it to connect with their customers and suppliers. Many labs take orders from and deliver test results to their customers via the Internet. The next step is to use the same capabilities to manage lab operations remotely, and check up on lab processes and test status off-site.
The next generation of lab automation will combine powerful, easy-to-use software with secure Internet access, which will provide lab personnel with continuous, real-time access to lab management. Patient privacy will be protected in compliance with the Health Insurance Portability and Accountability Act (HIPAA) by using stringent security features including data encryption, multilevel authentication, secure sockets layer (SSL), and firewall-friendly communications technology.
Improved software functionality combined with Internet-based real-time access will create significant productivity gains for labs as they are able to reduce personnel while increasing their testing volumes.
Real-Time Service Maximizes Uptime
IVD manufacturers build today’s automation systems with highly intelligent analyzers and equip them with sophisticated sensors that monitor every step of the testing process. However, much of the information in modern instruments remains locked inside the analyzer. As labs increase their testing volumes through automation, the systems are overworked, and downtime situations are not uncommon. Labs often have idle instruments available as backups and ask for same-day service from their vendors. The potential gains from lab automation are affected by physical maintenance and downtime of the analyzers.
IVD manufacturers are starting to access the analyzers’ built-in intelligence to monitor and diagnose the instruments remotely, thereby creating adaptable automation systems with better uptime. For example, DPC is using a connection between the analyzers and the vendor through the Internet to improve service. This connection facilitates the flow of information between the vendors and the labs. Such information includes not only real-time alerts indicating immediate problems with the instruments, but also event log information used to address issues that could cause future system failures. With such information, vendors can address the problematic issues at a convenient time for the labs rather than after a fatal event.
Using this technology, DPC has found that by anticipating service needs, service calls to labs can result in preventing system downtime. Internet-based real-time service will improve the uptime performance and reliability of the next generation of lab automation systems. HIPAA compliance will also be maintained through encryption, SSL, and other Internet security technologies.
In addition, connecting analyzers to the Internet not only facilitates the movement of information from the labs to the vendors but also provides a means for IVD manufacturers to offer information and services to the lab professionals to help them manage their activities. For example, DPC has used such a connection to collect quality control results from its instruments and provide them to the labs. This technology can generate reports for the labs in real time and can download composite peer information to a Web browser at any time, anywhere in the world. This connectivity and this information flow allow manufacturers to help laboratory professionals manage their labs, deepening the partnership between them. In the future, this technology could expand such partnerships into managing test inventory, lab work flow, and other aspects of the labs required to ensure their quality and efficiency.
Conclusion
Three trends will drive laboratory automation’s future: smaller, more-flexible analyzers and automation based on next-generation technology including microfluidics; easy-to-use, powerful software for centralized lab management; and Internet-based real-time service for better uptime.
These trends in lab automation and information management will take labs into a world where the key drivers will be speed and flexibility. Labs will no longer need to make huge investments in large systems to achieve the required productivity. Labs will no longer need to wait for the next monthly summary of quality control results to find out how their performance compares with their peers. The technologies that are emerging in microtechnology and information systems will allow IVD manufacturers to partner with labs in ways never before possible to provide the needed productivity.
The world of laboratory technologists will change from one that requires them to be on their feet much of the day, running from one system to another, monitoring the progress of the analyzers, and intervening when maintenance or service is required, to one in which they remain seated and monitor the activities of the analyzers in the same room or remotely. More importantly, the dwindling resources of skilled laboratory technologists will be better used for higher-level activities such as reviewing test results and laboratory processes.
