Process reengineering combined with automation improves productivity, reliability, and provider and patient safety.
The anatomic pathology lab is rapidly evolving and, if current trends continue, fully automated digital pathology will soon become the norm. Not every lab scans every processed specimen slide to create digital images—not yet, at least. But compare the speed and convenience of transmitting digital files via the Internet or intranet with physically transporting glass slides, and the transition to digital pathology seems inevitable.
The biggest innovations in medical diagnostic systems are those that automate or minimize manual work previously performed by medical technicians (sorting tubes, decapping, centrifuging, loading analyzers, prepping and sorting materials for storage, and so forth) while optimizing workflow, improving productivity, and increasing patient safety.
“In general, automation is more and more a requirement because we’re trying to do a lot with very few people,” says Claudiu V. Cotta, MD, PhD, medical director of the Cleveland Clinic Foundation immunohistochemistry lab. “In the current economy, institutions are very cautious when it comes to hiring people, so you need to squeeze more productivity from the people you have. Even when the institution gives you the go-ahead to hire somebody, it takes a long time to find somebody because of this shortage of trained histo techs, especially immuno techs.”
Optimizing the advantages of automation involves more than just adding automated lab instruments. Cotta recently coauthored a white paper, “Innovation in Immunohistochemistry (IHC) Staining: Single Piece Flow IHC Slide Processing,”1 that describes how replacing six (BenchMark XT) batch processing instruments with four (BenchMark Ultra) single-piece flow instruments enabled the Cleveland Clinic Foundation lab to achieve the following:
• reduce overall IHC turnaround times;
• add a fourth order cutoff time;
• free lab personnel to attend to other value-added work streams;
• increase slide throughput per lab professional;
• Integrate urgent or STAT slides more easily into routine workflow.
The key to accomplishing this was Lean Six Sigma workflow consultation, also referred to as process reengineering. Ventana workflow consultants did a detailed time analysis and identified high-demand tests so the most common reagents could be
|Figure 1. The BenchMark Ultra instrument features improved efficiency through frequent, easy access to reagents and slides.|
preloaded into single-piece flow instruments. Lower-demand tests were assigned to three categories of batch runs: short IHC run time, long IHC run time, and in situ hybridization (ISH). Ultimately, 77% of the lab’s tests were shifted from batch processing, such as the BenchMark XT instrument, to single-piece flow platforms, like the BenchMark ULTRA instrument (Figure 1). The shift from batch processing to single-piece flow processing reduced turnaround time and the risk of human error inherent in batch handling of specimens.
“It was worthwhile,” Cotta recalls. “Our turnaround time went down 30%. More than 80% of our slides are out in less than six hours from the time of order. Before, it was at least eight hours.”
Pressure to improve turnaround time is a constant for pathology laboratories, often with direct consequences for patient care and treatment outcomes.
“There is significant gain in having the slides ready when the pathologist arrives, whether that is midnight or 8 AM,” advises Christa Hladik, HT(ASCP) QIHC, former lab manager for the University of Texas Southwestern Medical Center and coauthor of “Histotechnology: A Self-Instructional Text.” “It could mean a shorter patient stay in the hospital or starting treatment sooner for an aggressive cancer,” she says.
Hundreds of global powerhouse companies, including General Electric, Deutsche Telekom, Honeywell, McKesson, PepsiCo, Quest Diagnostics, and Samsung Group, have successfully implemented Lean Six Sigma principles. In fact, there are more Lean Six Sigma vendors than you can shake a black belt at.
The landmark 1999 Institute of Medicine (IOM) report, “To Err Is Human: Building a Safer Health System,” estimated that as many as 98,000 Americans annually die from medical errors that occur in hospitals. That report and its 2001 companion report, also from the IOM, “Crossing the Quality Chasm: A New Health System for the 21st Century,” focused attention on patient safety and healthcare improvement strategies. Lean Six Sigma concepts, which were effective in reducing process variation and improving quality in other sectors of the economy, began to be implemented in healthcare—including in anatomic pathology laboratories—around 2005.
In general, Lean is based on the premise that resources that do not create value for the end customer are wasteful and should be eliminated. This includes wasted time, wasted motion, and wasteful processes. “Lean Methods Improve Productivity”2 is a Ventana case study that illustrates how Oklahoma University Medical Center board-certified pathologists and their team created a more effective, efficient, and safer anatomic lab environment.
|Figure 2. The Symphony automated H&E slide-staining platform is an example of individual slide staining to preserve sample integrity and positive patient ID.|
Six Sigma, a process improvement methodology that originated in the manufacturing sector, is all about improving the quality of a product or service by eliminating defects and minimizing variability in work processes. Because they complement each other so well, these improvement practices are usually combined as Lean Six Sigma and often referred to as “process reengineering.”
In most other industries, errors can reduce profitability, erode company reputations, or adversely affect worker morale. In anatomic pathology labs, errors can harm patients. According to Hladik, the “weak links” in the chain of lab automation are “any touch points in the process that require human data entry or manual processing.” Mislabeling, for example, is invariably caused by human error. Replacing these human “touch points” with automated instruments not only increases lab productivity and efficiency, but also may enhance quality and patient safety. Hladik notes that quality monitoring is a requirement if a laboratory is accredited by the College of American Pathologists.
Automation reduces the cost of cancer care and improves patient safety, largely due to a dramatic reduction in slide mislabeling, which is a major source of error in nonautomated procedures.
“With automation you’re introducing a lot more standardization, so the same amount of reagent is being delivered every time, for example,” explains Gail Sanders, manager, Anatomic Pathology and Molecular Services, acting manager of microbiology in the Division of Laboratory Services at Sunnybrook Health Sciences Centre, an academic university affiliate in Toronto, ON, Canada. “You gain a lot more control over the process, and that’s what you want. You want to eliminate any opportunity for human error or any variability due to human manipulation.”
That’s important because all licensed labs in the province of Ontario are accredited to the OLA 15189Plus standard, based on ISO 15189, which requires that any quality deficiency be investigated by doing a root cause analysis. “Typically, there’s a fault in the process,” says Sanders. The OLA 15189Plus standard uses continual monitoring techniques, including mapping and documenting processes, to identify and maintain improvements. The standard is part of the Institute for Quality Management in Healthcare in Ontario.
Ventana installed the first BenchMark XT automated IHC stainer at Sunnybrook in 2007 and then provided workflow
|Figure 3. The Vantage workflow management system integrates with all Ventana automated slide-staining platforms for seamless workflow tracking, productivity, and chain-of-custody control.|
consultation when the Department of Anatomic Pathology decided to enhance quality tracking capabilities and replace obsolete equipment in the histology lab in 2009. Based on the success of that initial workflow optimization project, other process reengineering initiatives were launched and now, Lean Six Sigma principles are integral to how everyone in the lab functions. “It’s ingrained,” says Sanders.
Today, the Sunnybrook lab deploys the Vantage workflow management system and bar code technology specimen tracking system, five BenchMark Ultra automated slide staining platforms, two NexES Special Stains systems, and two Symphony H&E systems, as well as instruments from other vendors.
Getting the most out of all this automation requires not only workflow optimization but a way to keep track of where individual slides are in that workflow.
Integrating laboratory workflow management solutions with a web-based digital pathology image management application makes it possible for pathologists and lab managers to track an individual slide, in real time, from specimen accession all the way through processing and digitization. Moreover, it allows them to exchange and compare information with each other, even if pathologists and lab managers are on opposite sides of the globe (Figure 2).
With integrated digital solutions, pathologists using image management software can check the histology status of a pending slide; review a slide’s entire histology processing history; and provide image quality feedback to the histotechnologist for corrective action tracking.
Lab managers using laboratory workflow management systems can review the pathologist workflow of a case and run quality reports on digital slides.
Integration of these functionalities, sometimes referred to as “middleware,” provides important benefits to labs, pathologists and patients.
“Most important is that this is all real time,” says Hladik. “The pathologist or lab manager can enter the web portal on their desktop to find the answers or generate the requested data without disrupting the laboratory process. In the past, these activities would require someone to stop his or her task; leave the work station; search through papers, computer files or handwritten log books; and call back to report the findings.”
The well-publicized aging of the baby boomer generation is expected to increase demand for laboratory services, as this cohort enters its years of peak healthcare utilization. At the same time, qualified medical technicians continue to be in short supply. With the help of qualified Lean Six Sigma workflow consultants, lab automation can mitigate this labor shortage and increase productivity by freeing up lab personnel for value-added work streams.
Moreover, Hladik points out that tasks such as manual deparaffinization and antigen retrieval can expose technicians to toxic chemicals, high heat, and potential biohazards. Automated processing in closed systems minimizes these exposures and enhances technician workplace safety.
“It’s a win-win,” says Hladik.
Writer’s note: The lab managers who talked with IVD Technology for this article have Ventana instruments and middleware in their labs as well as instruments and middleware from other vendors such as Leica, Dako, Danaher, Thermo Fisher, and Abbott. The participation of these lab managers in this article does not necessarily mean they endorse Ventana products or services or the products and services of any other vendors.
processing-11712#axzz1pCzlZp8k. Accessed February 10, 2012.
2. www.ventana.com/product/page?view=workflowconsulting. Accessed February 10, 2012.
Robert P. Carlson writes exclusively about healthcare and human health biotechnology for an audience of thought leaders, providers, and payers. He lives near Zionsville, Indiana, and can be reached at firstname.lastname@example.org.