Experts from Johns Hopkins, Mayo Clinic, Cleveland Clinic, and Massachusetts General Hospital share insights

BY KAREN APPOLD

Since Lean and Six Sigma concepts have been around for more than a decade, your lab may have adopted some of their principles.

Lean, a customer-focused management methodology, relentlessly eliminates all waste from any operation. Lean tools identify and target seven types of waste: defects, overproduction, motion, overprocessing, waiting, inventory, and transportation. “Waste” is defined as any activity that is non-value-added to an
100 1017Medical technologists at Cleveland Clinic mocking up improved work flow. operation. Six Sigma focuses on improving quality by eliminating defects and minimizing variability. This methodology uses statistical analysis to determine the key contributors of variation, called “x’s.” Countermeasures are then initiated for the x’s that exert the most influence on the process. The improved process is more reliable and predictable because it produces fewer defects.

Some labs have implemented official programs to eliminate waste, while others use these improvement methodologies in specific areas as needed. Regardless of how formally the principles are adopted, one thing is certain: getting rid of waste and defects is a necessary means of survival in today’s demanding healthcare climate.

Here, experts from Johns Hopkins, Mayo Clinic, Cleveland Clinic, and Massachusetts General Hospital give you a glimpse inside their labs and share how these principles have helped them.

On the line

Lean and Six Sigma concepts originated in manufacturing, largely in assembly line-type processes where various people hand off materials to the next person in line. Each person performs a different process step until the unit is completed. Processes such as these offer significant opportunities to reduce waste, variation, and defects. “Many processes in health care, including the lab, are similar to a production line, so the principles are easier to grasp and apply directly,” says Richard Hill, CLSBB, senior quality innovation coach, Johns Hopkins Armstrong Institute for Patient Safety and Quality, Baltimore.
It may be getting harder to separate the idea of good business from good health delivery.

Rich _Hill_Johns_Hopkins “Many processes in health care, including the lab, are similar to a production line, so the principles are easier to grasp and apply directly.”—Richard Hill, CLSBB, senior quality innovation coach, Johns Hopkins Armstrong Institute for Patient Safety and Quality, Baltimore


“Underperforming medical labs are not immune from being driven out of business through inefficient operations,” says
Matthew A. Clark, systems engineer, Mayo Clinic, Department of Laboratory Medicine and Pathology, Rochester, Minn, who notes that Mayo Clinic laboratories have been using Lean and Six Sigma for more than 8 years. “The health and well-being of our families and patients are too important to not take action to improve the cost and quality in this sector.”

The Centers for Medicare and Medicaid Services estimates that in 2012 the United States spent $2.8 trillion on healthcare services. Of that amount, nearly $750 billion was waste.1

 Mayo Clark Matthew “Underperforming medical labs are not immune from being driven out of business through inefficient operations.”—Matthew A. Clark, systems engineer, Mayo Clinic, Department of Laboratory Medicine and Pathology, Rochester, Minn

 

Benefits bear fruit

Lean principles support a focus on the customer. “In healthcare, our customer is the patient,” says Kandice Kottke-Marchant, MD, PhD, chair, Cleveland Clinic’s Robert. J. Tomsich Pathology & Laboratory Medicine Institute, Cleveland. “Everything we do is to make the overall experience better for the patient, and that is exactly what this promotes.”

 Cleveland KMarchant “Everything we do is to make the overall experience better for the patient, and that is exactly what this promotes.”—Kandice Kottke-Marchant, MD, PhD, chair, Cleveland Clinic’s Robert. J. Tomsich Pathology & Laboratory Medicine Institute, Cleveland.


Lean tools also help employees to do a better job. “By removing waste, tasks become more easily accomplished and meaningful to the person performing the work,” Clark says. “This leads to improved job performance and satisfaction.”

Donna MacMillan, BSMT, MBA, director of lab operations, Massachusetts General Hospital, Boston, says the more complicated the workflow, the more likely there will be errors. “We want to simplify our workflows as much as possible to minimize errors,” she says. The hospital has unofficially incorporated some Lean components into its process-improvement model.

Mass Genl_Donna_MacMillan  “The most effective use is to pick a piece of the model that works for the situation you’re trying to address and go with it. Doing everything all of the time could actually be a waste of time. If it’s a project to manage the project, something is wrong.—Donna MacMillan, BSMT, MBA, director of lab operations, Massachusetts General Hospital, Boston

 
Getting started

Determining how to improve begins by recognizing a failure or a risk of failure in meeting a patient or physician need. “We may find that a certain test is not meeting turnaround time expectations, or we may discover that a certain task takes longer than expected to perform,” says Richard O. Carlson, systems engineer, Mayo Clinic, Department of Laboratory Medicine and Pathology, Rochester, Minn. “External forces, such as those driven by the recession or by healthcare reform, may expose risks in our processes that could lead to dissatisfied physicians or patients.”

Mayo Carlson_Richard  In many cases we can use value stream mapping to provide a visual representation of the current situation. This methodology gives an end-to-end view of a process, which helps us determine where process constraints exist and identify approaches that will lead to improved flow, improved quality, and lower costs.”—Richard O. Carlson, systems engineer, Mayo Clinic, Department of Laboratory Medicine and Pathology, Rochester, Minn


To understand the nature of these problems, the Department of Laboratory Medicine and Pathology at the Mayo Clinic turns to mapping the process. “In many cases we can use value stream mapping to provide a visual representation of the current situation,” Carlson says. “This methodology gives an end-to-end view of a process, which helps us determine where process constraints exist and identify approaches that will lead to improved flow, improved quality, and lower costs.”

At Cleveland Clinic, continuous improvement is part of its culture. An internal institute’s continuous improvement team is specifically dedicated to the laboratory. Following are some of the most commonly used methodologies:

• Spaghetti diagrams help to chart and depict the waste of traveling through a work area.
• Direct process observation helps leaders see firsthand what was occurring at the frontline level.
• Standardizing work helps to document best practices and create new standards to form a baseline and continue to improve.
• A daily management system helps to see critical issues affecting the institute on a daily basis.
• Problem-solving is a system that includes FasTrac™ from Orion Advisory LLC, Charlotte, NC, root cause analysis, and A3 methods to enable process redesign. A3 is a problem-solving approach to help groups put down problems on one piece of paper to identify solutions.
• 5S shows how to best organize a work area with sorting, setting in order, shining, standardizing, and sustaining.

Growing more lean

When Cleveland Clinic designed a new laboratory building—the Tomsich Pathology Laboratories, which opened in 2012—Lean played a significant role in the design. “By conducting workshops with frontline technologists, we identified waste and developed a more efficient and productive work environment,” Kottke-Marchant says. “We developed a new inventory management system that has streamlined the supply ordering and replenishment process.”

According to a study in the American Journal of Clinical Pathology that details the initiative, at baseline in 68 workflows, 251 (38%) of 664 tasks required workers to walk away from their workstations. After analysis and redesign, only 59 (9%) of the 664 tasks required technologists to leave their workstations to complete these tasks. On average, 3.4 travel events were removed for each workstation. Time studies in a single laboratory section demonstrated that workers spent 8 to 70 seconds in travel each time they step away from the workstation.2

Additional benefits include employee training in waste identification, improved overall lab layout, and identification of other process improvement opportunities in the lab.2

“We have seen firsthand how these principles have improved efficiencies and quality in our laboratories,” Kottke-Marchant says. “In turn, this is helping us to prepare for the changing landscape of healthcare by maximizing our resources and increasing flexibility.”

Hybrid Lean Sigma in action

Johns Hopkins bundles Lean and Six Sigma methodologies together because all processes can benefit from the application of both tools and principles. The program, called Lean Sigma, incorporates the five-step DMAIC framework: define, measure, analyze, improve, and control.

Hill says Lean Sigma is a team sport because it relies on the power of many to determine, initiate, evaluate, and refine the best interventions possible. The DMAIC framework provides guidance in this regard, as questions need to be answered in each step.

Throughout the DMAIC process, multiple visits are made to the lab to observe and learn based on what is observed and asked. “In the ‘define’ phase, we watch in order to identify the scope and create a visual depiction of the process—called a value stream map,” Hill says. “In ‘measure,’ we collect metric data to understand how our process is performing. In ‘analyze,’ we identify waste and determine the key inputs (x’s) that affect the process. In ‘improve,’ we launch and refine our interventions, and in ‘control,’ we sustain the gains by creating a system of continued monitoring and follow-up if needed.”

A common refrain in Lean circles is, “Seeing is believing; believing is seeing.” “If all of the improvement work occurs in a conference room, we talk about what we think happens or what should happen, and quite frequently it is somewhat different from what really happens,” Hill says, citing an example. “A team noticed that a lab tech only used one of two centrifuges. When we asked her why she did not use both, she stated that the closest one did not work properly for some time. The centrifuge was repaired immediately, capacity was increased, and efficiency improved.”

Lewandrowski  Kent Lewandrowski, MD, associate chief of pathology and director of pathology, Laboratories and Molecular Medicine, Massachusetts General Hospital, and professor of pathology, Harvard Medical School, both in Boston, notes that most errors occur in the preanalytical phase. The lab is now using technology that alerts users if an ordered test is not usually indicated. “This helps us to ensure that doctors ordered the correct test,” he says.

Measuring the improvements

As a result of using Lean and Six Sigma principles, clinical labs report improvements in many categories. Here is a sampling:

Workflow/turnaround time:

• By using Kaizen, Cleveland Clinic was able to improve 1-hour compliance with emergency department stat chemistry test turnaround times from 74% to 97%.
• By using FasTrac, Cleveland Clinic improved timed draws for anticoagulant monitoring from 38% to more than 60% compliance within the therapeutic range.
• Cleveland Clinic used A3 to improve throughput for antibody screening in transfusion medicine. The first stage of this project reduced turnaround time by 19 minutes (from 145 minutes to 126 minutes).
• An improvement to a transportation process that delivers specimens from the hospital campuses to Mayo Clinic’s central testing lab will save about $2,400 annually.
• In genetic sequencing, Mayo Clinic used root cause analysis and design of experiments to reduce process variation and clarify process parameters to decrease repeat testing rates by 72%.
• A project that examined the processing and testing of kidney stones helped a Mayo Clinic team improve the process flow through work leveling that increased the rate of specimens through the testing process by 46% per full-time equivalent (FTE) hour, delaying the need to expand the lab space for this testing process.
• An automated lab at Johns Hopkins improved goal turnaround time from 85% to 98% largely by changing the layout and reducing handling and wait times.

Conservation by the numbers

• An automated immunoassay lab at Mayo Clinic created a level loading model to match instrument capacity with the rate of incoming specimens. This model showed the potential to reduce excess consumption of controls by more than $250,000 a year on a single instrument.
• Johns Hopkins saw a reduction of red blood cell wastage in its blood bank from 4.4% to less than 2%. In addition to the increased blood availability, it yielded more than $250,000 a year in savings of purchased units. The reduction was a result of standardization of container packing and improved processes for detecting blood temperature.

Making best use of personnel and space

• At Cleveland Clinic, an inventory management system saved more than $600,000 annually through workforce efficiency.
• A workflow and workspace optimization project in a clinical microbiology lab at Mayo Clinic resulted in a 0.5 FTE savings and created enough capacity to perform 23,000 new assays annually.
• In an anatomic pathology laboratory at Mayo Clinic, developing standard work to eliminate waste resulted in a reduction of FTE effort by 10% per test and a reduction of turnaround time by 20%. An additional process change will increase the lab’s testing capacity by 20%.

Pinpointing where to reduce errors

Kent Lewandrowski, MD, associate chief of pathology and director of pathology, Laboratories and Molecular Medicine, Massachusetts General Hospital, and professor of pathology, Harvard Medical School, both in Boston, notes that most errors occur in the preanalytical phase. The lab is now using technology that alerts users if an ordered test is not usually indicated. “This helps us to ensure that doctors ordered the correct test,” he says.

Mayo Clinic reduced specimen collection kit change order errors for outpatient transplant patients by 71% through process mapping and by defining clear role definitions for all involved in the process.

Taking action in your lab

“Using Lean and Six Sigma can be intimidating if you feel you have to use the full-blown model offered by consultants, published in various publications, or presented at meetings,” says MacMillan, Massachusetts General Hospital’s director of lab operations. “The most effective use is to pick a piece of the model that works for the situation you’re trying to address and go with it. Doing everything all of the time could actually be a waste of time. If it’s a project to manage the project, something is wrong.”

AMONG THE COMPANIES OFFERING PRODUCTS THAT
FACILITATE LEAN LAB OPERATIONS: (click on links)

Abbott
bioMérieux
CompuGroup Medical
Helmer Scientific
Milestone Medical
NovoPath
Orchard Software
Ortho-Clinical Diagnostics
Roche Diagnostics
Siemens Healthcare
Sunquest
Sysmex America Inc
Viewics
Visiun

 

  

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References:

1. Smith M, Saunders R, Stuckhardt L, McGinnis JM, eds. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: The National Academies, National Academies Press; 2013. Available at: http://www.nap.edu/catalog.php?record_id=13444. Accessed September 4, 2013.

2. Yerian LM, Seestadt JA, Gomez ER, Marchant KK. A collaborative approach to lean laboratory workstation design reduces wasted technologist travel. Amer J Clin Path. 2012;138(2):273-280.

Karen Appold is a contributing writer for CLP. For more information, contact Editor Judy O’Rourke, [email protected].