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Applying Lean Concepts in a High-Volume Molecular Diagnostic Microbiology Laboratory

shutterstock_143212498Clinical laboratories are continually challenged to do more with less, while maintaining and improving their quality and productivity. Further, these laboratories are facing increasing test volumes, demand for shorter test turnaround time, and a decreasing supply of skilled laboratory staff.

One laboratory trying to tackle each of these challenges is the Hepatitis/HIV Molecular Laboratory at the Mayo Clinic in Rochester, MN. Since 1993, the laboratory has offered molecular HIV and viral hepatitis tests utilizing polymerase chain reaction (PCR), branched-chain DNA (bDNA), and sequencing methods.

mitchell

P. Shawn Mitchell, Hepatitis/HIV Molecular Laboratory supervisor

In 2004, the Hepatitis/HIV Molecular Laboratory operation was not running in an efficient manner, specifically not meeting published turnaround times of test results. According to laboratory supervisor P. Shawn Mitchell, “While quality was being maintained, there were areas that could be improved, such as first-time success of clinical assay runs.”

The laboratory decided to adopt a two-year approach to implementing Lean concepts to improve these areas. Lean is a continuous-improvement methodology that improves customer service, performance, and quality by reducing waste, process variation, and imbalance. The process helps to identify the value stream(s) and highlight waste that can then be eliminated. The ultimate goal is for each step in the process to create value to the customer.

Over the two-year period, the laboratory underwent several exercises and employed various changes, including:

  • Participation in educational sessions on Lean concepts, emphasizing the four basic principles and how to improve processes.
  • Identification of “kaizen” initiatives (continuously improving in incremental steps) that could potentially decrease or eliminate wasted efforts and improve workflow.
  • Implementation of workflow and operational process changes.

shutterstock_204096127As with any major change to laboratory operations, applying Lean principles may result in setbacks. According to Mitchell, the laboratory initially experienced incorrect information from the vendor from an instrument run-time standpoint.

“Based on the information provided, we planned for updates to the processes within the laboratory. When we did not see the expected results, discussions between our staff and the vendor uncovered these issues,” says Mitchell. “However, once we finally learned how the instrument could operate and process samples, we discovered a new option the vendor did not even know about.”

While these “speed bumps” occurred, other Lean activities were successful, and the data and graphs showed improvement in the lab’s operations, which buoyed the staff’s enthusiasm for the Lean journey.

The fourth principle of Lean is to, “recognize optimally that Lean is a way of being and, as such, it is a journey and not a destination.” According to Mitchell, Mayo Medical Laboratories has benefited from adopting the Lean approach and will continue to see success with it.

“The Lean process is now the mindset of our laboratory personnel. Decisions are made based on what these employees experience and learn from a Lean processes. As new tests, instruments, and processes enter the laboratory, Lean guides us as to what is the best way to implement each of these items,” says Mitchell. “Basically, we ask ourselves, ‘What does this mean from a Lean standpoint?’ with every project, potential issue, etc., that we may have.”

Read more about these Lean initiatives in the July 2014 issue of Journal of Clinical Microbiology.

Mitchell, P.S., J.N. Mandrekar, J.D.C. Yao. 2014. Adoption of Lean Principles in a High-Volume Molecular Diagnostic Microbiology Laboratory. J Clin Microbiol 52:2689-2693.

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