LabNotes - Volume 18, No. 1, 2008

Error-proofing the Laboratory

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Lessons from Toyota
by David A. Novis, MD, FCAP

Patients are demanding that healthcare institutions do a better job at reducing errors. Medicare says they will no longer reimburse hospitals for medical errors, and third party payors and state hospital associations have begun to follow suit. Finding new ways to mistake-proof clinical laboratories is becoming crucial. The mistake-proofing system developed by Toyota may be one that is worthy of our attention.

Why Do Errors Occur in the Laboratory?

Countless newspaper articles and television news programs constantly remind us that at times, mistakes occur in the laboratory. Why do these errors happen? Studies conducted by the Institute of Medicine in 1999 (To Err is Human)1, 2001 (Crossing the Chasm)2 and 2006 (Preventing Medication Errors)3 all arrived at the same conclusion regarding laboratory errors. The good news is that these events are not the result of employees who work in the laboratory. Healthcare seems to attract some of the brightest, most dedicated, and most hard-working individuals in any industry. Instead, it is the system.

Possible Root Causes

In my view, the system upon which we have relied to avoid making errors in the laboratory is based on benchmarking. We define measurable indicators of quality, collect data on the indicators and analyze the data statistically to determine targets, or benchmarks of performance. At the same time, we survey the practices by which services are provided and then stratify the benchmarks by those practices to determine which practices we believe to be the “best.”

To some degree, this approach seems to work. For instance, participants enrolled in the College of American Pathologists’ benchmarking programs Q-Probes™ and Q-Tracks™ claim that benchmarking data helps them determine the weak spots in their laboratories as well as how and where to spend money to reduce errors4. Participants who track quality indicators over the course of several years do indeed show continuous improvement. Chasing benchmarks as a strategy by which to reduce errors does seem to offer some benefit, but critics cite some serious flaws:

  • Misplaced Targets. Medical errors in the clinical laboratory—at least serious errors—are, for the most part, rare enough to require years of study in order to accrue enough data from which to draw conclusions. Interventions designed to make those events even rarer can require lifetimes to see whether or not they’ve made improvements. What we are often forced to measure instead, are operational processes—the frequencies with which people perform the tasks.

  • Choosing Benchmarks. In general, performance achieved by the top five or 10 percent (95th or 90th percentiles) of participants is designated as the “benchmark.” This is not necessarily the best performance possible, only what the top five or 10 percent were able to achieve. Sometimes, sights are set even lower, perhaps the 75th percentile, rather than settling for nothing less than perfect performance.

  • Reacting instead of Preventing. We tend to question our performance only when it dips below a certain threshold or is triggered by some catastrophe, rather than to brainstorm ways to prevent errors before they occur.

  • Slow to Change. While we often enter cycles of monitoring and intervening, at times, these cycles may go on forever, allowing whatever flawed environments that precipitated the error to continue. Ideally, systems could detect and correct errors immediately before they can cause harm.

  • One-Size-Fits-All Approach. Just because “best practices” seemed to work in somebody else’s laboratory does not necessarily mean that they will work in yours. In fact, Q-Probes™ studies have shown that some of the “best practices” employed in the top performing laboratories were also employed in the bottom performing laboratories. It is not always clear why some laboratories do or do not function well. Therefore, we need to devise and customize systems that work in our own environments.

Another Option:   The Toyota Pyramid

Given the shortcomings of relying solely on a benchmarking system to avoid trouble, it may be worthwhile to investigate other systems of service delivery. The most copied production system on the planet, copied not just by manufacturing companies but by service providers as well, is the one developed by the Toyota Motor Corporation.

Applying industrial techniques to the delivery of health care services does not mean turning healthcare workers into robots and patients into engine blocks. Activities involving people (i.e., hematology technologists identifying leukemic cells on peripheral smears) must be differentiated from activities involving systems (i.e., ensuring that the peripheral blood slides are labeled properly). It is the system, not the people, which requires fixing.

Pickup trucks or peripheral smears, the goals of production systems are the same. Every laboratory’s goal is to deliver their services at low cost, at high quality, and safely. Toyota’s approach is worth reviewing since they have achieved these goals so well. Their vehicles are among the top rated in quality, safety, and reliability. Why are they successful and what ideas can be borrowed from them?

Toyota’s system has been viewed as a pyramid constructed of four blocks: a sound business philosophy operationalized by Toyota’s unique production system, driven by people, instilled with a culture of continuously improving the system. The supporting base of the pyramid is the commitment of top management to sacrifice short-term profitability in order to achieve long-term growth. This business philosophy, as simple as it may sound, is essential for driving the other components of the system.

The philosophy is operationalized by the Toyota Production System (TPS), also known generically as the lean production system. Lean is not a Toyota word, however, it was coined by Womack, Jones and Roos in their book The Machine that Changed the World to describe what they believed the TPS was trying to accomplish5. Of its many components and techniques, two principles stand out with regard to reducing errors: eliminating all waste in production and building quality directly into products.

Eliminating Waste Eliminates Errors

Toyota describes seven cardinal wastes in industrial production, to which Jeffery Liker, author of the thoughtful study of Toyota, The Toyota Way6 has added an eighth:

  1. Overproduction. More inventory is presented to a work station than can be processed efficiently. For instance, at 6 AM, buckets of specimens from patient care units throughout the hospital arrive in our laboratories. Upstream, work backs up as technologists labor furiously to generate test results. Downstream, doctors and nurses are idle, waiting for the test results needed to advance the care of their patients.

  2. Unnecessary movement. As an experiment, try diagramming the flow of work and traffic in your laboratory—from the arrival of specimens to the release of reports. It won’t take a lean expert to convince you of the unnecessary movement that this drawing represents.

  3. Overprocessing. Overprocessing is the half dozen or more admitting notes written by the emergency room doctor, house officer, hospitalist, specialist, etc, all of which say the same thing that the pathologist has to read before commencing the autopsy.

  4. Overstocking. Stocking an entire shelf of large-size gloves in a laboratory in which there are no large-sized hands is wasteful and contributes to excess inventory.

  5. Unnecessary transport. Routes by which specimens journey from the bedsides to patient to the laboratory may not be optimal due to facility constraints, resulting in testing delays and creating opportunities for errors to occur.

  6. Unnecessary waiting. Waiting for a patient to return from X-ray in order to draw blood may not be the best use of a phlebotomist’s time.

  7. Defects. Erroneous laboratory reports require repeating tests and investigating the origin of the errors.

  8. Unused employee creativity. Failing to solicit ideas on how to improve operations from those who are in the best position to provide that information is, in my opinion, the most egregious waste in any industry.

In most industries, waste is dealt with by either hiding it or working around it. In the long run, this requires more effort, more resources and more capital than what may be required to eliminate the waste altogether.

The following are dots that Toyota-style production engineers might connect to deal with waste:

  • Remove the silos. Silos—phlebotomy, receiving, rocessing—serve only to increase the distance between operations and make communication among operators more difficult.

  • Plot the flow. With the silos removed, diagram the steps of production from the time specimens enter the laboratory to the time reports are released.

  • Identify the value. For each step, determine which ones do and do not provide value to patients. For instance, drawing blood and examining peripheral smears provide value. Transporting specimens and waiting for instruments to become available do not.

  • Eliminate the waste. Finally, eliminate as many non-value steps as possible. Don’t touch the value-producing steps. In fact, consider spending more time providing value, more time examining blood smears.

Every wasted step removed from the process takes with it another opportunity to make an error and generate a defect.

For instance, a CAP Q-Probes™ study7 of transfusion practices demonstrated that removing wasted steps—transporting blood directly to patients’ bedsides rather than allowing couriers to make several stops along the way, and having only one person handle the products rather than allowing units to pass through multiple sets of hands—was associated with fewer process errors.

Investigators at the University of Michigan8 were able to remove wasted steps from the process of installing percutaneous ntravenous catheters (PICC lines) into patients. The entire process, from time of physician’s order to the actual PICC insertion procedure, was reduced from an average of 4 days to 7-10 hours. Errors, measured as First Time Quality (the number of times the procedure was performed without a hitch), went from getting it right one out of three times to performing flawless procedures almost 9 out of 10 times. The amount of time spent on value (the one-on-one time that doctors and technicians spend with their patients) increased by 10 percent.

Building a Safety Net to Catch Defects

Building quality into the product directly as it rolls down the assembly line is a matter of making errors visible as soon as they occur. Defects that are identified can be corrected before they are passed on to consumers. In manufacturing, making errors visible is achieved through standardization and redundancy.

Standardization is doing the same job, the same way, every single time. Redundancy is catching defects that sneak past standardization, since no matter how tightly we standardize our procedures, something is bound to go wrong.

In both the factory and laboratory, standardization means parts that are color-coded and that fit together in only one possible way. It also means developing protocols that describe every movement and operation. Idiosyncratic improvisation is to be eliminated, since it presents opportunity for errors.

Redundancy in operations is aimed at decreasing the intervals between the occurrence, detection and repair of errors. The goal is to eliminate defects before they can be passed onto patients.

Building redundancy into the system is a matter of inspection: how often we take a step back and look at what we’ve done. One method of inspection that has been shown to reduce manufacturing defects by as much as 90% is termed successive checks. Successive checks require workers to inspect another’s work before they start turning wrenches themselves. In the laboratory, Q-Probes™ studies7 have shown that having one transfusionist read patient identification information to another before starting transfusions is associated with fewer process errors. Several studies have demonstrated that having one pathologist check the work of another before tissue diagnoses are released to clinicians results in fewer diagnostic errors.

The goal of inspection in lean production is the source inspection. Source inspections represent standardization that is so complete, inspection itself becomes unnecessary. For instance, a radio frequency device (RFD) placed into a machine part will alert assemblers that parts have not been installed correctly. In the laboratory, RFDs are finding their way into wristbands.

From the Factory to the Laboratory

At Toyota, workers correct defects before they can be passed on to customers. If a worker spots a defect and cannot correct it immediately, he/she pulls a cord, which stops the line and summons a supervisor. If the two cannot solve the problem, engineers are brought to the floor to perform the necessary root cause analysis. This root cause analysis is accomplished on a problem that occurred five minutes ago, not five weeks ago. As inventory is exhausted up and down stream, additional conveyor segments come to a halt. Any assembler is empowered with the ability to shut down the entire line; this is not just a matter of salvaging one part. The engineers want to diagnose the cause of the problem to avoid more surprises later in the day.

If any front-line assembly worker is allowed to shut down the line, how does the factory get any work done?

Anyone who has ever worked the night shift in a busy laboratory probably knows the answer to this. Problems encountered but ignored at 2 AM do not disappear by themselves. They often reappear at 8 AM, only to become more disruptive. Any supervisor who has had to discuss a “lost” specimen with an irate doctor knows that it is a lot easier to track down and repair the damage if the incident occurred 10 minutes ago than 10 weeks ago.

Completing the Pyramid: People and Culture

The system works because the people Toyota employs make it happen. Toyota goes to great lengths to maximize the effort of its number one resource—its people. They start by getting the right people on board; applicants are not hired indiscriminately simply to fill holes in schedules. Applicants undergo months of interviews and testing. Toyota endeavors to hire only those individuals whom they believe will be committed to the ethic and culture of the company.

In turn, Toyota makes a commitment to their employees. No one is fired as a result of economic downturns or automation. In addition, workers are cross trained, as necessary. Technology is used to support workers, not replace them. Candidates are not passed up for promotion, instead, Toyota grows leaders from within the company rather than bring in managers from the outside. Once the best people are hired, they are empowered to initiate improvements in the jobs they do every day. In this way, management does not need to instill a culture of continuous improvement in them; the employees instill the culture themselves.

Hypertherm, a company in New England that has adopted the Toyota system, provides an example of this. Hypertherm manufactures arc welders. They employ 900 people, manufacture their products in the United States, and command three quarters of the world market for the type of welder they make. For several hours every month, workers are pulled from the line and given time to brainstorm ways to improve the operation. They design experiments to improve safety, reduce errors, be more efficient, reduce overhead, and develop outcome metrics to test their hypotheses. They need not convince top management to allow them to perform the experiments, only the people sitting around the table. This is a culture of error reduction that is proactive, blameless, and self perpetuating.

The results have been impressive. In 2005, these 900 employees offered 2,500 suggestions to improve production, 1800 of which were incorporated into factory operations. In 2004, the numbers were about the same, as they also were in 2003. This presents the question: how many of your laboratory’s employees were given the opportunity to come forward with suggestions on improving workplace safety or reducing errors?

Perhaps the biggest challenge that hospital and laboratory managers face in implementing Toyota-inspired production principles is the assumption that these improvement projects are one-time events. As dramatic as some improvements may be, there is always room to improve further. There is always room to encompass other areas of the laboratory and then move beyond the laboratory walls to other departments in the hospital. Continuous improvement must be built into the job description of every employee.

Dr. David Novis has practiced laboratory medicine and pathology for 25 years and is a recognized expert in practice management, clinical quality, patient safety, and service delivery. He serves as a content resource and advisor for a wide range of laboratory, pathology, and general medical consulting firms.

 

References

  1. Kohn L, Corrigan J, Donaldson M, Eds. To Err is Human: Building a Safer Health System. Committee on Quality of Health Care in America, Institute of Medicine, 1999.
    www.nap.edu. Accessed April 24, 2008.

  2. Crossing the Quality Chasm: A New Health System for the 21st
    Century. Committee on the Quality of Health Care in America, Institute of Medicine, 2001. www.nap.edu. Accessed April 24, 2008.

  3. Aspden P, Wolcott J, Bootman L, Cronenwett, L, Eds. Preventing Medication Errors: Quality Chasm Series. Committee on Identifying
    and Preventing Medication Errors, 2006. www.nap.edu. Accessed
    April 24, 2008.

  4. www.cap.org. Accessed April 25, 2008.

  5. Womack JP, Jones DT, Roos D. The Machine that Changed the World:
    The Story of Lean Production. New York, NY: Harper Perennial: 1991.

  6. Liker J. The Toyota Way. New York, NY: McGraw Hill: 2004.

  7. Novis DA, Miller KA, Howanitz PJ, et al. Audit of transfusion procedures in 660 hospitals: A College of American Pathologists Q-Probes study of patient identification and vital sign monitoring frequencies in 16,494 transfusions. Arch Pathol Lab Med 2003;127:541–548.        

  8. Kim C, Spahlinger D, Kin J, Billi J. Lean health care: What can hospitals learn from a world-class automaker? J Hosp Med 2006;1:191-199.

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