The most noteworthy changes and innovations in clinical laboratory automation in the past 5 years include walkaway analyzers; the use of decision-making software; the increasing availability of electronic tools for testing and reporting; and the development of middleware linking hardware and software.

Professor of pathology and director of clinical chemistry and information systems at Oklahoma University Medical Center, Kenneth E. Blick, PhD, ABCC, NACB, oversees the center’s Chemistry and Immunoassay/Endocrine laboratories. He says key advances in lab automation—what he calls “show stoppers”—are related primarily to his lab’s ability to rapidly move accurate information and results from the patient’s vein to the physician’s brain.

The wide use of walkaway analyzers that perform testing free from lab-tech intervention; the increase in patient testing at the point of care; the development and use of advanced, decision-making software; the move to real-time testing with the elimination of batch technology; and the increasing availability of electronic tools for sample collection, identification, and results-reporting rank among the biggest advances of the past 5 years, according to Blick.

“We in the lab are in the information business, and those information demands continue to expand,” he says. “Our job is to extract information from a sample and get it to the physician. What counts is the quality of the results – not the whiz-bang stuff. That’s where high-speed analyzers come in.”

To keep up with the high volumes and demand for testing 24/7, the core laboratory is equipped with three chemistry analyzers, each of which can operate at peak performance for as long as 30 days before required calibration. Sophisticated software serves as a traffic cop, providing load balancing—assigning an even flow of testing to the analyzers.

“That ability to load balance enables us to keep up with test demands even when we have to take an analyzer offline for maintenance,” Blick says.

His testing process includes nurse specimen collection and pneumatic tube transport, robotics and automated core instruments, autocentrifugation, autoreceive, refrigerated specimen stockyard storage and electronic paperless orders from nurses, wireless physician orders, and real-time paperless reporting. The lab manages nurse-performed critical-care testing at the point of care when needed.

 Kenneth E. Blick, PhD, ABCC, NACB

To keep up with the information flow, Blick’s lab employs eight computers that talk to one another continuously. It’s that level of technology that enables his lab to handle physician orders sent by wireless, complete a menu of tests, and send the results back to the physician in as few as 10 to 20 minutes—even when the physician is several blocks away.

“Our track system keeps specimens moving in real time,” Blick says. “If we have specimens sitting around in racks at the lab, that means we have patients sitting around waiting for results.”

Electronic cost-capturing is another automation issue. “The business side of the laboratory is essential; you must collect for what you do or you’re out of business,” Blick says.

He believes that the next 2 decades will be an exciting time for those dedicated to pathology and laboratory medicine. “We’ll see better markers, better ways of doing molecular testing,” he says. “Heart attacks, strokes, molecular fingerprinting, more targeted therapies—the chemical levels in the cells is where the action is going over the next 20 years, and the laboratory is right in the middle of it all.”

Automation at Mather Memorial Hospital
Denise Uettwiller-Geiger, PhD, DLM (ASCP), is administrative director and clinical chemist at John T. Mather Memorial Hospital in Port Jefferson, NY. Geiger and her lab staff of 58.5 full-time equivalent positions (FTEs) process more than 1.6 million tests every year for her 248-bed hospital and outside clients.

 Denise Uettwiller-Geiger, PhD, DLM (ASCP)

The most noteworthy advances since 2001 include the advent of faster and integrated analyzers, along with automation and autovalidation, according to Geiger. Among other key innovations is the development of middleware linking hardware and software. This has enabled labs to consolidate test information from various instrument systems and manage data in real time.

Five years ago, Mather installed a powerful automation system that has helped the lab speed up delivery of accurate test results to physicians in the emergency department (ED) so they can more quickly diagnose and begin treating patients.

Automation has made a major impact on improving turnaround times (TAT) at Mather Memorial Hospital. For drugs-of-abuse tests, TAT was reduced by 79%. The automated system has helped the lab absorb an increase of 82.6% in total volume of tests performed, while its FTEs remained the same.

Refinements within the lab have gone a long way toward improving the flow of patients through the ED, according to Geiger. These changes have enabled the lab to have a consistent and predictable process. “We handle an average of 45,000 ED visits a year, and that’s a lot for a hospital our size,” Geiger says. “Our automation has permitted the lab to achieve a turnaround time—from time of order to results—of 45 minutes or less for the ED.”

According to Geiger, the next generation of middleware—with its capacity to better integrate software with hardware—offers labs like hers the flexibility to build rules that can be easily custom-fitted to the particular practices and operations of an individual lab. “Middleware has been extremely helpful in pulling all the clinical information together, providing the ability to offer a patient-centered approach,” she says.

Positive patient identification using bar coding has been a focus at Mather Memorial Hospital. Through the use of bar coding, the facility has virtually eliminated identification errors. Though much acclaimed, the field of molecular diagnostics has yet to reach its potential for smaller hospitals. But the technology is still evolving.

Mather Memorial Hospital’s commitment to new technology has been a powerful magnet for recruiting lab staff. Geiger says applications are on the rise because people know the hospital lab has robotics and they want to work in the safe, high-tech environment that automation offers.

Nicholas Borgert is a contributing writer for Clinical Lab Products.

Another View: Lean Trumps Technology
Leo Serrano, FACHE, is director of laboratory services and Lean initiatives at South Dakota’s Avera McKennan Hospital and University Health Center in Sioux Falls. McKennan is a 500-bed tertiary care facility. The lab staff of 106 full-time equivalents (FTEs) processes more than 2.6 million tests each year for medical-center patients and outreach from clinics across three states.

“I am a firm believer that achieving process excellence or perfection is far more important and should be achieved before spending the money on automation,” says Serrano, a Lean Six Sigma Black Belt.

McKennan, facing an old and cramped lab in dire need of more space, launched a Lean program in 2004. The facility’s medical director and other administrators pushed for the change to Lean. Visits to successful lab operations in Omaha and Minneapolis encouraged the move even more. Space needs were satisfied when McKennan purchased an on-campus medical office building and turned it into a new lab. The Lean Process was well under way when Serrano assumed his post. 

“Our Lean process began at specimen collection and continued throughout the core of the laboratory [chemistry, hematology, urines, coagulation] that generated 80% of test volume,” Serrano says. “Lean principles enabled our facility to use technology more wisely.”

In addition to designing more efficiency into its processes, technology helped make the processes more error-proof. Serrano’s facility has used its laboratory information system (LIS) to reduce opportunities for errors and enhance patient care. McKennan has changed the way it uses its LIS.

“We have maximized our LIS, and we are finding tools within the standard system and using them in creative ways,” Serrano says. “We have also evaluated each of our instruments, and we are making changes to further improve our processes.” Because not all analyzers are Lean-friendly, the lab has been updating analyzers as contracts allow. Changing to single-piece flow and first in/first out (FIFO) practices cut turnaround times significantly, he says.

Serrano says Lean principles are proving valuable in other departments, too. To date, all of the operations within the clinical laboratory have been “Leaned.” The Anatomic Pathology section is readying the construction phase of its redesign.

“Applying Lean principles to microbiology was a concern in the beginning, but it actually turned out to be quite rewarding and not nearly as daunting a task,” Serrano says. “We read our cultures in a FIFO manner, and our microbiologists have adapted to the standard work protocols exceptionally well.”

The lab’s work processes are designed to turn out simple cultures immediately. Problem cultures are then passed across the bench to the problem bench. That approach enables the lab to meet its turnaround-time targets while offering a high degree of expertise.

The expert system makes it even easier to convert to Lean, according to Serrano. The lab also converted its blood-culture system to a more Lean-friendly system. Lean successes have attracted interest from hospital areas. “We have completed initial and secondary Lean projects in the emergency department and in PeriOperative Services, as well as initial projects in Housekeeping and Behavioral Health Services,” Serrano says. “We have completed a Design Excellence event in our Telemetry areas, and a pharmacy Lean event served as a teaching tool for senior management. When staff sees the CEO doing a Lean project, they realize it is here to stay,” Serrano says.

Serrano says his wish list would include a combination of software and hardware that would make specimen handling more error-proof. “We have found that front-end automation, as it exists today, does not improve our speed or accuracy,” Serrano says. “We are looking at electronic order entry at the point of service (in-house or outreach) along with bar coding/RFID [radio frequency identification] to improve accuracy in preanalytic clerical functions.”

He says “sneaker netting” in a highly refined work cell is far more cost-efficient than expensive total automation. The McKennan lab processes a manageable 2,200 samples per day. “Once you get to 6,000 to 7,000 samples a day, total automation becomes far more palatable and necessary,” he says. “Different labs must find the solution that best addresses their needs.” —NB