American Association for Clinical Chemistry
Better health through laboratory medicine
Patient Safety

Patient Safety Logo


Engineers in the Clinical Laboratory
An interview with Patrick Fasse, BSME, Industrial Engineer, ARUP Laboratories, Salt Lake City, Utah, and Brian Nass, MSME, MSIE, Director of Process Improvement, Mayo Clinic, Rochester, Minn.

Engineers routinely use disciplined problem solving methods, like Lean and Six Sigma, to improve processes. In recent years, interest in these engineering methods has soared in the clinical lab industry as evidenced by the availability of educational events and materials related to these topics. However, a gap exists between discussion of engineering methods and the actual use of those methods in labs. To close the gap, some health systems and larger labs have employed engineers to lead process improvement initiatives. In this interview, two engineering leaders, Patrick Fasse from ARUP, and Brian Nass from Mayo Clinic, discuss the engineering approach to improving clinical lab performance. Michael Astion, MD, PhD, conducted this interview.

Q: What is your educational and work background?
Fasse:
I am a mechanical engineer. Before coming to ARUP, I was part of a consulting group that worked on a variety of material handling issues. The main focus was to apply world class Lean techniques to eliminate waste in the warehouse distribution industry. During my tenure there, we implemented automated conveyor/sorting systems and improved overall material handling throughout all operations. I have no formal healthcare education.
Nass: I have master’s degrees in mechanical engineering and industrial engineering. Before coming to Mayo, I worked for many years in computer hardware and software design and manufacturing. I specialized in applying the Toyota production system in this setting. I have no formal healthcare education.

Q: Is your background a natural fit for the clinical lab?
Fasse:
Yes, the movement of specimens, reagents, people, and information around a lab is analogous to the engineering problems I worked on before joining ARUP. Problems in clinical labs are amenable to engineering solutions.
Nass: It is a very good fit. The clinical lab is a great area in which to begin applying Lean in healthcare. The end-to-end testing process—from specimen receipt, sorting and preparation, through analysis and reporting—is relatively linear, and the process issues are the same as those commonly encountered by engineers in other industries. These include rework, mismatch between staffing and workload, batching, unplanned equipment downtime, calibration problems, and lack of standardization.

Q: What are some of the projects you have worked on?
Fasse:
My original project with ARUP was to reduce the time it took for a specimen to move from the delivery truck to specimen processing and then to the bench. Most of my other projects involve using Lean methods to reduce waste and build in more capacity to our system.
Nass: Most of the projects I have worked on involved applying Lean techniques to improve turnaround time, quality, and cost. At Mayo Clinic, we have since spread the application of Lean to radiology, surgery, nursing, the emergency department, cardiovascular diseases, and several outpatient procedural areas.

Q: What is your approach to working with lab staff to redesign a process or workspace? How do you gain buy-in?
Fasse:
I mainly see myself as a facilitator. I start each project with a teaching session regarding Lean techniques. I go over some common types of lab waste (see insert) and let them know that I am open to the possibility of lab redesign. I then observe the work in the lab where the project will occur and talk to individual techs. My main goal is to help them generate ideas that will improve quality.
Nass: Before starting on a project, I ensure that the lab leadership supports the initiative and are open to having me observe the processes directly. After making initial observations and a preliminary assessment of the situation and opportunity, I serve mainly as a teacher of Lean and as a guide to help the staff apply Lean thinking to all aspects of the lab. When I started in this position, I taught using examples from manufacturing. But now that we have had a number of successful projects at Mayo Clinic, I use those examples instead. My overall objective is that lab staff will not need me once they have completed a few Lean projects with me or my team’s assistance. In addition, I try to get the different lab divisions to learn from and help each other. This involves using staff who have successfully participated in a Lean project outside of their own area. This provides new project teams an outside set of eyes, and the prior Lean project’s expertise helps spread the teaching into new areas.

Q: Mr. Nass, you were involved in a project that improved work flow in the molecular diagnostics lab that performs virology testing. What was your approach to that project?
Nass:
In that particular case, high demand was causing increased delays and rework. First, I observed the work in the lab. I then worked with a small team of lab supervisors and techs to create a current state value stream map (see insert, below). The map allowed us to see how specimens flowed through the lab and how the final work product—the test result—was created and delivered, all from the point of view of the customers, who are physicians and their patients. The value stream map, in conjunction with observing the lab work, allowed us to identify critical problems which were corrected rapidly.

Value Stream Mapping to Identify Waste

As it applies to lab testing, value stream mapping is a Lean method to analyze the work required to bring the test result to the physician and patient. The test result in the hands of physician and patient is viewed as the ultimate product of the clinical laboratory. This product is the result of a group of processes. Each process falls into one of three categories:

It is waste, and should not occur.

It does not add value to the product, but it must occur (e.g., fulfillment of certain regulatory requirements).

It adds value to the product.

The main idea in re-engineering work processes is to get rid of the waste. Below are some examples of waste in lab testing.

Common Types of Waste in Clinical Labs

Waste Categories

Examples

Delays

Batching in any part of the lab testing process

Delays related to using serum (requires clotting) rather than plasma

Delays between test order and sample draw, sample draw and arrival in lab, receipt in lab and specimen processing, specimen processing and analysis

Analytic delays

Postanalytic delays in reporting results

Delay in retrieving results by care provider

Transport delays between different lab sections

Duplication

Duplicate specimen collection and test orders

Correction/ Rework

Redraw due to suboptimal specimens (e.g., line contamination, hemolysis, quantity not sufficient, clot, wrong temperature)

Redraw due to mislabeling

Repeating tests because of analytic error

Any other error leading to a corrected report

Motion/Steps

Positioning the most commonly used analyzers far away from specimen processing

Using a multi-step manual assay, when an automated assay with fewer steps is available.

Reagents and materials for testing placed too far from technologist

Inventory mismanagement

Insufficient inventory

Too much inventory (e.g., reagents outdating before use)

Modified from reference 1.

Q: What were the areas for improvement?
Nass:
The analysis of the specimens was the rate limiting step. Within that rate limiting step, there were several correctable problems causing delays. The batch sizes were too large, so we reduced them. There were insufficient signals to identify the end of a batch run, and this meant instruments were sitting idle, waiting for a technologist to identify a completed batch. Similarly, there were insufficient signals to identify problems that either slowed or halted analysis. We put in visual and auditory signals so that instruments were used nearly continuously. By using small batches and enhanced “pull signals” to pull the next batch onto the analyzer, we removed nearly all the waste within the rate limiting step.

Q: What was the outcome?
Nass:
In one week of intense work, we reduced turnaround time in that lab by 50% and improved the capacity to handle additional volume. Schedules became more predictable, the amount of overtime decreased, and morale improved.

Q: Why do you aim for rapid improvement?
Nass:
Staff find it highly motivating because it sends a clear message that meaningful change is within reach.

Q: Does lab leadership always have to be involved?
Nass:
The supervisors have to be there from the outset of the project. In general, their presence, participation, and buy-in are necessary for the project to succeed.

Q: Mr. Fasse, can you describe the work you have done related to decreasing wasted motion in the lab?
Fasse:
We sometimes waste a fair amount of motion performing lab tests that leads to delays in testing and inefficiency in allocation of labor. Specifically, if you watch techs perform during the analytic phase of testing, sometimes you see disorganized work areas that lead to wasted movement and unnecessary travel to obtain reagents, ice, and other supplies.

Q: Can you give us a specific example?
Fasse:
There was one area where tests were done with the aid of an automated pipetting system. In this area, techs were traveling a great distance to retrieve vats of distilled water from a water dispenser. After I provided some Lean training, we decided to redesign the process. We ended up bringing a water dispenser right next to the bench where the test was being performed. This decreased the distance traveled to perform the tests by 40%. In general, our approach is to have techs move less by working closer to their instruments in uncluttered work spaces. This leads to decreases in the analytic time and makes the work environment more pleasant.

Q: Why are work areas disorganized, when many techs are highly organized?
Fasse:
One interesting source of clutter that leads to unnecessary motion as techs travel around it is excess inventory of testing kits, reagents, ice, and other supplies near the work bench. The oversupply is driven by fear of having insufficient materials to carry out testing, which makes sense because insufficient supplies block the tech from completing their main mission: delivering quick and accurate test results to our clients. To overcome this fear and reduce clutter, reliable systems for delivering inventory to the bench must be developed. Once techs have confidence in the delivery system, they will not hoard supplies, and the benches become uncluttered. The main goal of all this is to produce more space for work within the existing lab footprint.

Q: When analyzing a lab process, do you find that your objective differs from that of lab technologists and technicians?
Fasse:
We usually view the objective as the same, but we may have a different view on the path to achieve that objective.
Nass: My main objective is knowledge transfer; therefore, setting goals for turnaround times, quality, etcetera, come from the lab staff.

Q: Have you found that a lack of clinical lab training impeded your ability to contribute to the lab?
Fasse:
It has not been an impediment. I bring a complementary set of tools to the team. Engineers are able to see the unnecessary layers that have been added to work, and are used to redesigning processes. Engineers are also comfortable with a green field approach, by which I mean we rip all the layers off a process and take a fresh look.
Nass: Lack of lab training has actually helped, because I have been able to ask the naïve questions without being burdened by the past. As outsiders to the lab, we can see things that insiders cannot see.

Q: Large labs have the resources to employ an engineer. However, most clinical labs are smaller operations that cannot afford an engineer, or even engineering consultants. How can smaller labs implement an engineering approach?
Fasse:
It does not have to be an engineer. It can be as simple as choosing somebody in the lab who is interested in becoming an expert in Lean/Six Sigma. These people can get some special training and then can be a local expert in process design in a smaller lab. They can accomplish a great deal, especially related to removing waste in processes.
Nass: I like the idea of a lab champion who receives special training, perhaps at a local community college, or university. Another approach is to gain expertise by partnering locally with somebody in an industry where Lean and Six Sigma are routinely used. Industry experts are often quite willing to share expertise in a meaningful way, and this can be less expensive than consultants.

Q: What types of lab projects can benefit most from an engineer’s involvement?
Fasse:
Clinical lab experts are in the best position to develop and implement policies and procedures for lab testing. Engineers can help in important ways that are not necessarily reflected in the test’s policy and procedure. These include decreasing distances traveled by techs, decreasing other forms of unnecessary movement, and reducing excess inventory. In general, engineers are useful for developing custom tools to complement a process, such as automated conveyor systems to improve specimen transport within the lab, spatial redesign of a lab, or customizing the workspace where instruments are located.
Nass: All projects can benefit. The lab faces several classic engineering issues: poor layout; batching; swings in demand/capacity; quality problems; and non-optimal use of equipment. All of these are amenable to engineering approaches, specifically Six Sigma and Lean. In addition, I would mention that as I work throughout Mayo Clinic, the engineering approach is particularly good for a number of procedural areas, including surgery, radiology, gastroenterology, cardiovascular labs, and the emergency department. These areas have relatively linear processes consisting of a check-in, preparation, a procedure, and post-procedure work, including analysis and reporting of results and/or outcomes and follow-ups.

Q: From an engineering perspective, what are the greatest opportunities for the future that a lab should embrace?
Fasse:
We still have a great deal to learn from manufacturing, especially applying Lean to all parts of our operation. Through engineering methods, we have a great opportunity to build more capacity into our systems while creating better working environments.
Nass: There is an opportunity in the lab, and throughout the healthcare system, to become more proactive about patient safety issues by introducing engineering tools such as fault tree analysis. These tools could let us predict serious events, like lab errors, medication errors, or life-threatening sepsis, before they happen, and intervene so that they do not occur.

REFERENCES

Getting lean not mean: morale, leadership, and integration issues surrounding LEAN in the laboratory: An interview with Dr. Joe Rutledge and Joanne Simpson. 2006. Laboratory Errors and Patient Safety. 2(5): 1–8.

Persoon TJ, Zaleski S, Frerichs J. Improving preanalytic processes using the principles of lean production (Toyota production system). Am J Clin Path. 2006;125:16–25.

Liker JK. The Toyota Way: 14 Management Principles from the World’s Greatest Manufacturer. McGraw Hill, 2004.

Kibak, P. Tools for Benchmarking Performance: How Lean, Six Sigma improve lab efficiency and Quality, CLN, 2008;34:4, 1.


Patient Safety Focus Editorial Board

Chair
Michael Astion, MD, PhD
Department of Laboratory Medicine
University of Washington, Seattle

Members
Peggy A. Ahlin, BS, MT(ASCP)
ARUP Laboratories
Salt Lake City, Utah 
James S. Hernandez, MD, MS
Mayo Clinic College of Medicine
Rochester, Minn.
Devery Howerton, PhD
Centers for Disease Control and Prevention
Atlanta, Ga.

Sponsored by ARUP Laboratories, Inc.
ARUP Logo