With the majority of clinical decisions relying on diagnostic tests, the onus is on clinical laboratories to process a high volume of clinical chemistry tests as efficiently and accurately as possible. This has been made possible by increased reliance on automation.
By Ann H. Carlson
Behind every laboratory test is a human being waiting for potentially life-changing news. With laboratory test results driving nearly 70% of today’s medical decisions1, the onus is on clinical laboratories to process a high volume of clinical chemistry tests efficiently and accurately to get patients and their health care providers the results they need as quickly as possible.
To meet this high demand, automation has been an integral part of most clinical chemistry workflows for decades.
“Clinical chemistry was one of the first disciplines to be widely automated,” says Nick Smith, vice-president and head of marketing for Tecan. “This was partly due to the high number of test requests and also the fact that common assay principles allowed multiple tests to share common detection modules such as absorbance readers on a single system.”
Common automation solutions include random access analyzers that no longer pause when reagents and consumables need to be loaded, as well as automated calibration and quality-control on-board analyzers that decrease hands-on time with equipment, according to Lisa Rose, executive vice president of core laboratory solutions and diagnostics for Siemens Healthineers.
“More recent advances in instrument technology and engineering have opened the door for sophisticated testing capabilities on chemistry systems, such as consolidating specialty assays into routine chemistry operations and longer, uninterrupted run times to improve testing capacity and efficiency,” Rose notes. “Additionally, reducing patient sample sizes through pre-dilution can reduce the impact of draw volumes for sensitive patients.”
Although the shortage of laboratory technicians was felt keenly before the emergence of the COVID-19 virus, the pandemic brought the realities of running an understaffed lab into stark relief. Today’s clinical chemistry automation solutions concentrate on reducing downtime, increasing standardization, and expanding automation into the traditionally manual steps of the process to relieve an overwhelmed staff.
“Agility in the lab is increasingly critical,” Rose says. “Automation was once viewed as ‘nice to have,’ but it has since become a ‘must have’ in the lab to keep pace with growing testing demand, to alleviate the burden on laboratory staff, and to standardize workflows to maintain quality and reduce errors.”
Improving Clinical Chemistry Workflows
Several factors have contributed to the recent demand for more automation in laboratories, notes Corinne Fantz, PhD, DABCC, vice president of medical and scientific affairs, Roche Diagnostics North America.
“The barrier to entry for automation in smaller size laboratories has decreased with laboratory staffing shortages, and the ability for pre-and-post-analytical solutions to handle more complex tests and workflows for labs has improved over the past decade,” Fantz says. “We are also able to automate more disciplines, including integrating connected molecular testing as well as hematology, coagulation, urinalysis, and esoteric testing. In the future, automation will allow labs to add new technologies into their core labs, including liquid chromatography-tandem mass spectrometry.”
Another big consideration is finding ways to reduce costs. “Laboratories have had a hard time being profitable, especially in the mid-tier segment of labs,” says Cheri Walker, PhD, president, CEO, and founder of Rhinostics, a company that formed at the height of the COVID-19 pandemic to provide automated solutions for swab test workflows. “Capital is hard to come by right now, and there’s a lot of pressure on hospitals and laboratories to find cost savings.”
By giving labs the ability to handle larger test volumes without the need for breaks, automation cuts the cost per clinical chemistry test significantly, and these solutions are also less prone to expensive errors when handling dull tasks such as decapping tubes or transferring over volumes. Research suggests that an estimated 46% to 68.2% of errors—such as mislabeling or using an incorrect tube—occur in the pre-analytical phase2, which is why providers are looking to offer automated solutions earlier in the process.
“Humans are amazing, and we do a lot of things right,” Walker says. “But when you’re doing a lot of repetitive motions, it’s pretty easy to make a mistake. Robots are better at that. They don’t care how many times they do something.”
Freeing up well-trained employees for more interesting tasks can also help with staff retention. “If you think about about the 4 billion COVID tests done around the world, [laboratorians] were decapping the majority of those by hand,” Walker adds. “It is a miserable job. What we’re seeing right now with a 30% to 35% turnover is that these are not jobs that people are really excited about. The more repetitive tasks there are, the more they just don’t like it longer term.”
Overcoming Obstacles
Most laboratories recognize the overall advantages of increasing automation; however, cost concerns, space constraints, and reluctance to change current clinical chemistry processes can delay action to onboard new technology.
“I think the biggest one is just inertia, the idea of, ‘We’ve always been doing it this way,’” Walker says. “It’s a mindset shift for sure. But once we get people through those hurdles, they’re really excited to implement automation.”
Part of successful implementation is moving away from the idea that automated solutions should follow existing manual processes. “To implement automation, there needs to be a vision of what could be versus trying to replicate what is,” Fantz says. “It’s key to keep an open mind about what the new technology offers rather than trying to replicate current workflows. Focusing on site and staff implementation readiness and post-implementation support are also essential to optimize adoption and minimize disruption.”
Funding an automation project can also seem daunting in the current financial climate. “The initial capital investment in today’s strict budgetary healthcare environment can be a challenge,” Rose admits. “Though the lab provides exceptional value for a healthcare institution or system, it is sometimes underfunded.”
Even when the benefits of the technology are clear, staff need manufacturer support to successfully implement it. Take, for example, onboarding the new Rhinostics ELEstic automation system, which is designed to de-cap 96 large-format tubes in 30 seconds versus the 18 minutes required to complete the same task manually.
“In the current market, it’s really just trying to work with staff to help them figure out the small details,” Walker says. “Sometimes it gets down to, how do you go from a smaller-sized tube to a bigger size? What kind of label do you use? You get into problem solving on how to make these changes fit with what the hospital is used to or what the patient is used to.”
Looking to Clinical Chemistry’s Future
Laboratories are experiencing innovations at every level in the clinical chemistry testing process, according to Fantz.
“Breakthrough biomarker assays such as the Roche Elecsys Alzheimer’s disease CSF ratio and the Roche Elecsys HIV Duo assay are examples of reagent innovations that are increasing access to new therapies and evolving clinical algorithms for care,” she says. “Other reagent improvements allow for longer onboard stability, more automated maintenance, and autocalibration of specific assays.”
Fantz predicts that labs of all sizes will continue to introduce automation technologies for all stages of the clinical chemistry testing process. “The digital solutions landscape will expand and advance, resulting in greater laboratory efficiencies and faster reporting of results to patients,” she says. “Continued innovation in automation will allow for increased integration with home testing and be able to support self-collected specimens sent to local labs, with a goal to improve patient outcomes while reducing barriers to access and hospital readmissions for conditions such as heart failure.”
Walker also anticipates finding innovative ways to solve new problems with automation. “We want to automate those samples that nobody wants to touch or deal with, such as urine and feces,” she says. “They need only 200 microliters for testing, so why not ship the sample in something small? And why not ship it in the right format labs can use and find ways to automate that whole process?”
The clinical chemistry hardware itself is also improving, with smaller footprints and more digital tools on the horizon. In the near future, Smith anticipates more smart components for preventive maintenance of automated systems. For example, additional sensors could give labs advance warning when a pump is about to fail to help labs maximize up-time.
Another element is monitoring the overall efficiency of the lab—both onsite and remotely. Tecan’s Introspect system, for instance, allows lab managers to see how many hours a day a system is in use, which operators have used it, and what types of failures have occurred. “For example, they could see that a particular instrument is underutilized on Thursday afternoons, so maybe they could move some tests over to become more efficient,” Smith says. “It allows them to manage the lab in a more dynamic way.”
While Smith predicts a role for artificial intelligence in automated systems down the road, it is too soon to guess what this will look like. In the near-term, however, he foresees more intuitive user interfaces across the board. “There’s a push toward simplicity,” he says.
In the meantime, labs will continue to seek out automated solutions for a smoother workflow. “Labs are looking for ways to operate beyond just standardization of shared reagents to decrease turnaround time,” Rose says. “They want to smooth out the peaks and valleys of their busy and slow times, and they are seeking equipment user interfaces that can improve workloads and ease the burden of regulatory compliance, which hinders their testing productivity.”
Laboratories also have a lot more confidence in the reliability of automated systems than they did in the past. “Automation is no longer a new technology, it is now a proven one,” says Rose, who notes that Siemens Healthineers’ track automation is now in its third generation. “We have extensive experience to intelligently manage the flow of samples through our IT portfolio, which has been developed with automation in mind. Complex routings can be completely automated for ease of use and standardization. Automation delivers full sample traceability and guarantees test results in a predictable time, which means the lab can operate more efficiently and cost-effectively.”
In general, today’s laboratories are more receptive to automation than ever before, especially when the system addresses a specific need. “I got involved with Rhinostics for more than just a plastic swab—it was recognizing a pain point in the diagnostics workflow that needed to change,” Walker says. “I think there’s a nice resurgence coming right now where people are really looking at what they want to add to their menu and what can they do to help their cost structure.”
Ann H. Carlson is a regular contributor to CLP.
References
- “Strengthening Clinical Laboratories.” Centers for Disease Control and Prevention. Nov. 15, 2018. https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html
- Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006;44(6):750-759. https://pubmed.ncbi.nlm.nih.gov/16729864/
