News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Clinical Chemists and Medical Laboratory Scientists Gather in Chicago for American Association of Clinical Chemistry and ASCLS Joint Meeting

Among the hundreds of lab industry vendors exhibiting, there were more companies showing LIS and lab informatics products this year than last year

CHICAGO, ILLINOIS—Anytime 20,000 clinical chemists and medical laboratory scientists gather in the same place, at the same time, there is sure to be many different opinions about the state of laboratory medicine and key trends in the clinical laboratory testing marketplace.

That was certainly true of this year’s annual meetings of the American Association of Clinical Chemistry (AACC) and the American Society of Clinical Laboratory Scientists (ASCLS) that took place here in the Windy City and ended yesterday. Your Dark Daily editor was in attendance and saw many interesting things during the exhibition, which opened on Tuesday and closed Thursday.

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FDA Clears New Rapid Clinical Laboratory Test for Market that Reduces Time-to-Answer for Bloodstream Infections to Two Hours

Nanosphere’s Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) gives pathologists and clinical laboratory managers a new tool in the diagnosis of septicemia

One of the more challenging diseases to diagnose and treat is septicemia. Traditional microbiology methods typically require two or three days before an accurate diagnosis can be made. Now there is news of a rapid test for bloodstream infections that can allow a hospital clinical laboratory to deliver an answer to physicians in as little as two hours.

It was just last week when the Food and Drug Administration LINK (FDA) granted a de novo petition to allow Nanosphere, Inc., of Northbrook, Illinois, to market its Gram Positive Blood Culture Nucleic Acid Test (BC-GP). This assay is design to be run on Nanosphere’s Verigene automated system. Because the time-to-answer is as little as two hours, this diagnostic technology has the potential to trigger swift changes in the current standard of care for diagnosing and treating blood infections.
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Innovative Labs Combining Lean and Automation in Clever Ways

There’s a hot new trend emerging among a handful of the nation’s more sophisticated and tightly-managed laboratories. These innovators have hit on a “lab operation home run!” They are combining Lean process improvement methods with the latest-generation automation solutions and highly-automated analyzers. As a result, they are achieving mind-blowing, amazingly fast turnaround times while simultaneously boosting med tech productivity and slashing operational costs. At the same time, such labs are avoiding the pitfall of “automating bad work practices.”

These pioneering laboratories are demonstrating that laboratory automation has come of age-particularly when the laboratory uses Lean Six Sigma methods to configure an instrument footprint and specimen flow through the lab, thus taking maximum advantage of automated systems and analyzers. This is a radical change from just five and eight years ago, when lab automation was less capable and most labs knew very little about Lean and Six Sigma approaches.

At the University of Texas Medical Branch (UTMB) in Galveston, Texas, the hematology department was among the first labs to explore the benefits of digitized images, produced by automated systems. It was a beta site for the early automated microscope that is now often seen in hematology labs. Process improvement methods, including Lean techniques, were used to re-engineer work flow so that the performance of automated analyzers and digitized slide images was moved to a very high level of throughput and quality. At this year’s Lab Quality Confab in Atlanta on September 24-25, UTMB Automation Supervisor Laurie Emanuel will present a case study on how her laboratory has combined automation, middleware, digital imaging, and process improvement methods to deliver faster, higher-quality results, even as the number of med techs needed in the department’s analytical line declined from three to just one.

Combining new, sophisticated automation systems with the Lean mindset is transforming the histology laboratory at Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota. Exciting new automation solutions are arriving in histology and this laboratory, proficient in Lean techniques, is developing unique work flow and work process approaches that are already exceeding industry norms for turnaround time, productivity, quality, and cost-effectiveness. Leo Serrano, Director of Laboratory Services at Avera, will be sharing these secrets at Lab Quality Confab.

Another area where automation is beginning to alter long-standing work processes is microbiology. At BC Biomedical Laboratories in Surry, British Columbia, the microbiology laboratory installed a new automated specimen processing/preparation system, then watched in dismay as work backed up at the instrument (Proving the truth of that industrial engineering adage: “Don’t automate bad work processes.”). According to Scott Henwick, M.D., Clinical Director, Microbiology at BC Biomed, the micro team then turned to the help of an experienced veteran of Lean. Microbiology workflow was reconfigured to incorporate the best applications of “pull,” takt time, and small batch/single piece workflow. Those simple changes unlocked the productivity of the automated system and the micro lab is posting continuous improvements in all important metrics. Dr. Henwick will discuss this case study at Lab Quality Confab in a session titled: “Why Automation Bollixed Efficient Workflow in Microbiology and How Lean Fixed It.”

These three examples embody this new trend of innovative laboratories combining, blending, and integrating automation solutions with Lean, Six Sigma, and process improvement principles. Laboratory managers, pathologists, and others wanting to understand this powerful new opportunity in lab management will find the second annual Lab Quality Confab on Quality Management in Diagnostic Medicine to be a comprehensive resource. Lab Quality Confab will take place on September 24-25, 2008 at the Hilton Hotel in Atlanta, Georgia.

More than 50 sessions and topics will be presented, covering the full range of laboratory and pathology operations, ranging from specimen collection and courier logistics to using Lean with automation in the high-volume core laboratory. Poster sessions will take place, and national awards and prizes totaling $6,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit http://www.labqualityconfab.com.

To register for Lab Quality Confab, visit http://www.labqualityconfab.com.

Finally, laboratory vendors are waking up to this highly-productive intersection of matching their automated systems and sophisticated analyzers with Lean, Six Sigma, and similar process improvement techniques. At Lab Quality Confab, management master classes will be conducted on these topics by experts from Ortho-Clinical Diagnostics , Siemens Diagnostics , Sysmex , BD Diagnostics , Abbott Diagnostics , and Beckman Coulter , among others.

Related Info:
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1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.

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