Making a Clinical Difference Using Lean Six Sigma in the Face of Resistance

Lou Gorga
Posted: 11/24/2009

Have you ever heard, "We can't address clinical outcomes using these tools! We're not making ball bearings here!" or the old favorite, "You can't apply these principles because there are too many variables and it is too hard to measure." If you have heard these or similar statements you might want to read how one team made a clinical difference in the face of this type of resistance.

Lean Six Sigma creates a data-based, measurement platform that provides a management team the information needed to devise a solution. Implementing the solution has more to do with management ability and stakeholder commitment. The following Lean Six Sigma project that shows how important that stakeholder commitment is and how one project team succeeded from an "unlikely" resource.

There Is a Place for Lean Six Sigma Within Healthcare

I have been reading a number of articles lately that hint at the belief that process improvement techniques (Lean, Six Sigma, Reengineering, TQM, etc.) have maximized their effectiveness. One article referred to these practices as "…practices based on neoclassical economics…" (Gallup, 2009) and that the significant competitive advantage from these practices has hit a point of diminishing return. So why would we consider using them in something as critical as patient well being?

First, we should address what I believe is a perception problem. Many of the critical articles seem to mistakenly interchange these process improvement methods and tools with leadership/management. However that may be an entirely different juicy article for the future. Second, there are still "new frontiers" where the Lean Six Sigma tools are relatively new to the industry. Healthcare is certainly one of those industries.

Healthcare is making strides to improve their performance, outcomes, costs and frankly their image by embracing developmental tools like Lean Six Sigma. Observers inside and outside the industry believe that there is significant room for process improvement and that it is an opportunity-rich environment. But where is the focus? Most initiatives gravitate to the low-hanging fruit that will generate quick, big wins. There is significant interest and activity around process improvement that generates bottom line contribution in relatively short order (e.g., revenue enhancement, capacity increase, reduced waste and cost reduction). Some of the healthcare enterprises are boldly using these Lean Six Sigma tools to improve clinical outcomes.

Applying Lean Six Sigma to a Clinical Outcome

One Lean Six Sigma team addressed the prolonged use of Foley Catheters. Prolonged use of the catheters increases the risk of urinary tract infections (UTI) in patients. UTI increase the risk of sepsis, sepsis increases the risk of morbidity. To paraphrase one of Verizon’s tag lines—"This is big"! It was also challenging.

The focus was directed on an adult medical/surgical/trauma ICU that was between 20-25 beds. The metric was the number of days a patient was on the catheter. Data collection was manual and the target was defined as 2.0 device days with an Upper Specification Limit (USL) of 3.0 device days.

The first challenge was the nursing staff. They felt that their patients (largely trauma patients) should not be candidates because of the patient’s medical circumstances and the nursing labor/effort required without catheters. Who could blame them? There is consistent pressure to "be more efficient," which usually translates to lower staffing ratios. So you can imagine how excited they were when they were asked to assist in the data collection. The Lean Six Sigma project leads knew the stakeholders. They focused their appeal for help on the academic nature of the project and the opportunity to definitively determine causative factors. It worked but you would probably characterize their initial participation as tolerant over enthusiastic.

The baseline capability of the Lean Six Sigma project was determined to be a mean of 4.72 device days with a standard deviation of 7.67 days and Defects per Million Opportunities (DPMO) of approximately 419,000. The team and process stakeholders reviewed the detailed processes in place. They addressed the need to more clearly define/describe the order-review and the catheter-removal protocol. Data was analyzed and the factor contributing most to the process variation was non-adherence to catheter review and removal protocols (Contributing 71.9 percent, determined by regression analysis; p=0.00).

The nurses decided to implement a "Check List," which would be nurse-driven. Understandably this new responsibility was not met with universal enthusiasm. In fact the Lean Six Sigma project team was brainstorming how to move the staff from tolerant to engaged. It was suggested that the extended team get together to work through the issues. No one was looking forward to this meeting.

When the Lean Six Sigma project leader called the extended team together the room was quiet with lots of arms folded across chests. Not a positive sign. As the Lean Six Sigma project leader was about to begin, one of the nurses asked to speak. Expecting a question on the value vs. effort to nursing of the project the facilitator braced for the worst. Instead the nurse related a story about a female patient that expressed her gratitude when the nurse removed the catheter that morning. The patient relayed to the nurse that when the catheter was removed she really felt she was on the road to recovery. You could hear a pin drop for the next 30 seconds. The facilitator spoke up first and said that the result expressed by the patient summed up what this project was really about. From that point forward the nurses were beyond engaged—they embraced the effort. A pilot was put in place that tested the suggested processes and techniques.

Post-pilot metrics showed that the mean dropped to 2.98 device days with a standard deviation of 3.17 with a DPMO approximately 226,000. Comparing the pre and post results showed that there was a statistical difference in the mean (p=0.03) and there was a 94 percent confidence that standard deviation was statistically improved. Education on revised processes and standard operating procedures were modified to reflect the new processes. The benefit was clearly shared between the patient and the institution and the staff was proud of the accomplishment, which had been completed in just over six months.

Leaders Who Can Communicate a Compelling Lean Six Sigma Message will Come Out on Top

The take away is that managing the process is the most important aspect of process improvement work. In this case management identified the problem, the staff developed the evaluation plan and collected the data, the data assisted in defining a solution but without the staff engagement and the commitment to the process the solution may never have been implemented. The role of the Lean Six Sigma project team is to build on the mission, create excitement and keep the team moving forward. Without this leadership things don’t change. The project leads have to find a way to make the objective compelling to the key stakeholders. Never an easy task but it is why successful Lean Six Sigma project leads prove to be "the cream of the crop."

To the critics who say that the process improvement tools may have outlived their usefulness we need to remember they are only tools. Tools are used to measure. Measuring is critical to effective management. I don’t think measuring will ever outlive its usefulness and these tools allow us a platform to teach people new ways to measure. Our "Next Generation of Leaders" will still need to measure. In fact our motto is if you can’t measure it—you can’t manage it. The next generation of leaders will also need to know how to move forward by creating and communicating a compelling message to achieve their goals.

Gallup. (2009, November 10). The Next Generation of Leadership. Quality Digest .

Lou Gorga
Posted: 11/24/2009


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