Expert Q&A: Key Issues and Developments in Clinical Lab Automation

Due to a variety of factors, automation is becoming more common in medical laboratories. Geisinger Medical Laboratories’ Diana Kremitske, MHA, MS, BS, MLS(ASCP), and Hoi-Ying (Elsie) Yu, PhD, DABCC, FADLM, discuss key developments in clinical lab automation, as well as their own experiences with these technologies and advice for lab leaders considering automation.

Q: What lab automation trends have you noticed recently?

DK: Microbiology methods are becoming more automated and equipment more modular. Within automated testing areas of clinical pathology, equipment from different vendors can now be connected to the same automation line. Also, sample integrity checking functions are evolving to more advanced technologies around reliable detection of various specimen quality issues, such as short volume samples or common interferents.

EY: In relation to the vertical track of lab automation systems, moving from 2D to 3D seems to be a common feature. Automating chemistry, hematology, and coagulation is no longer new, and I am now hearing about blood bank, urinalysis, and even anatomic pathology (AP) being automated. Direct connection with the tube system seems to be a new feature we have heard of being done in Europe, though it’s not as common in the US.

Q: What benefits has your organization seen from automation?

DK: The main benefits are in reducing time to result once the specimen is in the lab, particularly for test add-ons, as well as labor efficiencies, standardization of processes that help to reduce errors across all testing phases, and reduced consumption of disposable supplies.

EY: Achieving a lean process with efficiency gains—we were able to reduce the number of full-time equivalents (FTEs). Aside from number of FTEs, achieving a consistent process is critical. Also, the reduction of repetitive motion like pipetting reduces occupational injuries such as carpal tunnel syndrome. Reducing the number of footsteps that a human typically has to take to get specimens is also beneficial.

Q: What are the biggest challenges related to lab automation your organization has faced?

DK: A laboratory redesign process during years 2018-2019 has increased the volumes being directed to our core laboratory. The high testing volumes have naturally caused more wear and tear on the automation line at a faster rate than anticipated. Soon, we will be preparing a business case for automation replacement.

Depending on the configuration of a lab, automation may not easily fit in the existing space. A moderately sized laboratory in our organization will be installing an automated line configuration for chemistry, hematology, and coagulation. Although not an insurmountable challenge, it is a significant resource commitment to get space redesigned and additional renovations, as needed, to properly lay out an automated line.

EY: In terms of current automation, the issue is mainly upkeep. There have been three specific challenges: (1) We overused our current system so it is having more and more part failures of late. (2) Another issue is IT configuration. Automation needs SOP [standard operating procedures] to know what to do with each tube or test code in terms of specimen routing. That means detailed programming is required. There were times that we forgot to configure the automation system when new tests were added. (3) Prioritizing different STAT work. In a hospital setting, we have many different levels of STAT, but there really isn’t a good way for the automation system to prioritize them when there are too many different levels.

Q: How have you solved those challenges?

DK: For the design challenges, we worked on the space design in meetings with multiple stakeholders including the analyzer and automated line vendor, hospital administration, and the architects assigned to the project.

EY: For the challenges I outlined, (1) the vendor has been really helpful in doing preventive replacement on critical parts; (2) we have a process in place now to ensure each new test is being evaluated to determine if it needs to be programmed for automation and how. We are also updating the middleware system which has more built-in functions for enhanced specimen routing to improve efficiency; (3) for STAT work, it turns out human is still better. For example, we front load ED [emergency department] stroke / MI [myocardial infarction] alert samples.

Q: What regulatory compliance concerns need to be addressed when implementing automation in the lab?

DK: Something we learned is to be cognizant of any workforce adaptations that may cause personnel who weren’t initially considered testing personnel to be considered so after automation. For example, loading samples onto automated analyzers by laboratory assistants makes them testing personnel. Therefore, regulations related to testing personnel apply to laboratory assistants in these scenarios.

EY: Molecular testing should have a special certification to show there isn’t cross contamination with preanalytic units. The FDA also gives approval for instrument connectivity (which instrument is approved to be connected to what automation system).

Q: What advice do you have for lab leaders who are thinking of implementing automation?

DK: Carefully define the clinical, service, and efficiency metrics that should be measured pre and post implementation. Engage the vendor and laboratory / organizational IT teams early in the process to capture the pre and post implementation data. These data will be useful to demonstrate the benefits of the investment.

Determine expertise needs, whether in the laboratory or in IT, for rules writing related to middleware solutions. Assure this expertise is redundant somewhere in the teams as there are various types of programming rules that can be applied to help optimize workflows, and as test algorithms are instituted, or evolve, over time.

Include various stakeholders in the vendor evaluation and selection decision process, for example, testing personnel, preanalytical staff, clinical and scientific directors, and administrators. Early on, engage with IT personnel to support IT interface needs, such as configuration, and through the validation process. Invite IT leaders to contribute to the business plan with key metrics that may pertain to IT systems simplification, or reduced IT errors.

For these types of investments, reach out and ask peers about the pros and cons of the automation being considered.

EY: General things to consider include specimen capacity, instrument connection capability, and reliability. But one should be practical about want vs need. Many of the more open vendors can connect to just about “all” the common instruments. But just because they can doesn’t mean that it’s practical to, especially with the cost that may be associated with it from either a hardware standpoint, or from an IT configuration standpoint. Workflow is a key factor when thinking about automation design. It’s a lot more than just putting samples in and getting results. When evaluating workflow, we must look at the entire process (automated and any manual steps) to achieve the optimal design. Selection of testing instruments will make a significant impact on the automation line. For example, some instruments are more automated and allow for bidirectional transport. Other instruments may only allow for unidirectional transport. If a lab has more consolidated instruments (e.g. one vendor for all general chemistry, vs two vendors for all general chemistry), it will make automation implementation easier. As a general rule of thumb, automation also means standardization of workflow. The more standardized the workflow, the better it is for automation.

Q: How do you expect the major trends in lab automation to progress?

DK: Automation will continue to expand since the demand for laboratory testing continues to grow, and workforce challenges to support the work are continuing.

Automation line designs that connect directly to pneumatic tube systems for direct delivery of identified, barcode-labeled tubes to the preanalytics are an area for development as these would eliminate time related to specimens waiting to be tested and processes that are handled manually, such as, receiving, racking, and sorting.

Track design to move specimens from point to point will likely become even more flexible as laboratories will be pressured to introduce automation in smaller footprints or connect the automation to adjoining rooms to create efficiencies.

Automation in AP laboratories will likely develop more. There is some semi automation but the full automation that clinical pathology (CP) laboratories experience is not there yet in AP.

From a laboratory administrator’s point of view, systems that enable onsite, as well as remote management of automation systems’ performance throughout a laboratory enterprise would be the ideal. Performance management systems should also support real-time review of redundant systems when the primary [system] has a downtime, so that the laboratory maintains 100 percent uptime or quickly fails over to contingency plans. It would be also great if such performance management systems could be integrated in existing information system programs and would not require another separate program to be maintained or required to log into.

EY: I expect to see more lab automation in the future because of (1) advancements in technology, (2) more hospital mergers (aka bigger labs), and (3) not enough technical staff to do the work. I also expect more automation systems will be capable of handling molecular samples. Finally, for the US market, I hope that the automation vendors can integrate pneumatic tube delivery systems to directly receive the sample tube for processing / testing on the automation system. Currently, the process is mostly from receive-in-lab to testing.

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Diana L. Kremitske, MHA, MS, BS, MLS(ASCP), is the vice president of laboratory operations in the Diagnostic Medicine Institute at Geisinger. In her role she is administratively responsible for Geisinger’s entire laboratory operation, which is a comprehensive, integrated system having a state-of-the art core laboratory, nine hospital-based laboratories, five clinic-based rapid response laboratories, and numerous outpatient phlebotomy locations that span a large geographic area in Pennsylvania. She also oversees the health system’s courier operation, Geisinger’s patient blood management program, and apheresis clinics.

Elsie Yu, PhD, DABCC, FADLM, is a medical laboratory director at Geisinger Health System with a system leadership role in clinical chemistry, immunology, toxicology, and point-of-care testing. Board-certified by the American Board of Clinical Chemistry, she also serves as director of clinical pathology informatics and is a clinical associate professor at Geisinger Commonwealth School of Medicine. In 2016, she was named a 40 Under Forty Top Five honoree by the American Society of Clinical Pathology.