Automation is no longer an option for clinical laboratories. It's a must-have for labs to compete and innovate. But there are choices in the type and speed of transition, depending on a lab's needs and budget.
Many lab managers are using automation to maintain control over the influx of samples, ease workflow, improve safety, standardize processes, and reduce turnaround times. Automation can also help labs take on additional capacity and identify growth opportunities that could generate new revenue and make up for decreasing reimbursements.
Labs turn to automation to take advantage of its ability to handle mundane tasks and reduce the amount of manual work required of skilled personnel. This allows labs to give staff more important and productive tasks.
Octavia Peck-Palmer, PhD, director of clinical chemistry at the University of Pittsburgh Medical Center, was influential in transitioning her laboratory to full automation wet chemistry methods.
"From our standpoint, the motivation to automate was standardization, for example, of preanalytics, centrifuging, and aliquoting," Peck-Palmer said in an interview with LabPulse.com. "In addition, automation improved our turnaround time, ensuring that we get the samples on the instrument and analyzed quickly."
Having autovalidation in place was also important in terms of optimizing work efficacy and turnaround times, she added.
Not a job killer
Automation is not going to take the place of a laboratory's staff, Peck-Palmer insisted. Instead, it allows staff members to work smarter by giving them the time needed to be more innovative, such as in determining how extensive a testing menu can be.
Automation in the clinical laboratory can take the form of a complete automation system, known as total laboratory automation (TLA), in which most, if not all, operations are automated. Modular automation is another option, in which a lab may automate less extensively, installing discrete hardware devices that perform specific tasks. This approach automates in customized, incremental steps, based on a lab's individual needs and budget. Modular systems may entail establishing independent work cells or automating pre- or postanalytical workflows.
The University of Pittsburgh Medical Center opted for TLA, which has streamlined workflow and reduced the need for human intervention, cutting down on the potential for errors, according to Peck-Palmer.
The best way to determine your automation needs would be to run a Lean Six Sigma process on your lab's operations, suggested Robin Felder, PhD, director of the Medical Automation Research Center and a professor of pathology at the University of Virginia.
Six Sigma is based on how all work involves processes that can be determined, measured, analyzed, controlled, and optimized. Work processes entail inputs and outputs. Controlling the inputs controls the outputs.
According to Felder, Six Sigma decrees that laboratories should achieve an error rate of no more than 3.4 errors for every million operations. Gaining Six Sigma quality necessitates using automation technology because it is difficult to avoid errors when manually performing the complex tasks found in clinical laboratories.
"Six Sigma is a process that finds efficiencies," he explained. "Once you determine your lab's efficiencies, you can hold them by implementing automation."
Automation should also be the foundation on which a Six Sigma program can be built and maintained. Six Sigma maintains quality even when new untrained labor is hired, he noted.
Peck-Palmer recommended that labs determine what their automation goal is. Cost is an important consideration, and automating certain lines is less expensive than automating an entire lab.
"We analyzed what our 'pain points' were, and how we wanted to change to improve," she explained. "We wanted to standardize so that we could easily share samples among different lab sections. We also wanted to speed turnaround times for our various clinics."
Some labs may harness automation to expand their testing volume, but they should determine how automation also could help their outreach programs. Without an end goal, automation could be expensive and not achieve what the lab intended. The sections of a lab most often automated include the chemistry and hematology areas, Peck-Palmer said.
In general, Felder indicated that laboratories serving a large base of physicians who order routine chemical testing are better off transitioning to TLA. Labs that perform more esoteric testing -- analyzing rare substances or molecules, such as molecular diagnostics, immunology, and microbiology testing -- would be better off instituting modular automaton to automate specific tasks.
Some labs do not have the budget for TLA and would rather automate incrementally. Many medium-sized and smaller labs are interested in consolidating their analytical workstations with task-targeted and modular automation to create a less expensive alternative to TLA. According to Peck-Palmer, how extensively a lab automates may depend on its volume and simply how much space it can set aside for the needed equipment. In fact, a lab may have no option but to go modular.
Felder estimated the minimum cost of automation at $1 million, which includes the cost of software, hardware, and reagents, since many vendors are IVD companies that supply automation in system packages. Peck-Palmer thought the minimum needed to institute some form of modular automation would be around $100,000.
Establishing strong vendor relationships
"When automating, it's a good idea to leave the automation up to one vendor with whom you can work out any challenges or issues," Felder said.
In the same vein, Peck-Palmer emphasized the importance of vendors working with labs as partners. This means training the lab upfront and raising awareness of any potential instrumentation issues.
"Vendors need to take the goals that labs outline and turn them into a reality," Peck-Palmer said. "They must come to a lab and analyze its workflow and find out where the bottlenecks are."
It is apparent that clinical labs will continue to face a variety of challenges that require them to implement some form of automation to keep up with increasing test volumes, improve workflow, and foster innovation.