Lean process QI plan can work well for IRBs

Target wasteful processes

Most major corporations and business sectors have adopted business quality improvement (QI) measures like Six Sigma, Lean Process, and others. But in human subjects research, this type of QI approach is fairly new, an expert says.

"The Lean Process involves gathering people who are involved in all phases of research together to define what the current state process is and to analyze which pieces of the research process add value and which add waste," says William A. Bornstein, MD, PhD, chief quality and medical officer of Emory Healthcare in Atlanta, GA.

The Lean Process was the basis of the Toyota production system and is used often in manufacturing, he notes.

"The focus on lean is to try to distinguish value from waste," he adds. "This gets into a more disciplined way than most of us are used to thinking about."

While some kinds of waste are necessary, such as waiting in line or waiting for inventory to arrive, many types of waste can be eliminated through process improvements.

The lean process identifies waste through several steps:

— Define value stream

— map current processes

— identify which of the pieces or parts of the process add value and which are waste

— rapid improvement events.

In human subjects research, the value involves a scientific product that advances knowledge and improves patient care, Bornstein says.

"Applying this process to clinical trials, we broke the value stream into parts, beginning with conception of the study and going to the point of actually enrolling patients," Bornstein says. "Clearly there's more to it than that, but that's the first bite we took."

Applying a Lean Process formula to research can be eye-opening: "We found that the process was very complex and there were multiple processes to the same end," Bornstein says.

Emory Healthcare illustrated the research process with a diagram on the wall.

"Then we asked people to use sticky notes to define the kind of waste that can occur," he says. "Waste can include things we do that we don't need to do, and they could also include defects."

The wall was full of sticky notes.

"The next phase of it was to come up with a future state that would eliminate as much of the waste as possible and define a desired state," Bornstein says.

During this process, the people involved with the Lean Process should pause, take an insider's look at the current processes, and think about their findings.

"For the value stream analysis you need to step back because so often we're in the midst of getting things done, and we'll do work-arounds that we know aren't ideal," he explains.

"In manufacturing, you visit the production line," he adds. "In the IRB processes, it's less about physical places and more about having all of your stakeholders present in the room."

So one possibility is to hold a rapid improvement event, in which teams meet for several days to drill down into that area of concern and look at the mechanics and how to redefine the process, he says.

"Another common feature in quality improvement activities is the trial and error process," Bornstein says. "It's like the scientific method where you have a team of people involved in the steps and process."

A team might have identified areas that are not standardized but which could be and other areas that need some focused improvement activity, he says.

"You look at whether you can drill deeper in this area and what the current state is," he adds. "We go in there and try to redesign in real time how the trial works."

This is an ongoing activity.

One example of applying the Lean Process to IRB work would be to take a look at the length of time researchers wait for IRB approval. This form of waiting is a waste and can create delays, and some of it could be improved.

"What can we do to reduce that waiting, streamline the process?" Bornstein says.

There might be some improvements that can be done easily and someone could be assigned to make those changes. Called "just do it," these are the low-hanging fruit.

Other changes are more complex and might require a rapid improvement event in which a group of experts and staff are involved.

Still others could be long-term solutions.

"These might be an area where we won't prioritize it now, but we think it's waste and we may want to come back to it," Bornstein says.

An example is information technology improvement.

"By using information technology we may be able to improve reliability and reduce waste, but it requires longer-term planning," he explains. "So in the meantime, what else can we do to reduce waste?"

Emory Healthcare has used the Lean Process for more than five years as one tool for its quality improvement efforts, and it continues to be a learning process, Bornstein says.

"Many people who've written about the Lean Process point out that it takes years to learn how to do this," he says.

Even as a research organization begins to use the process, it can gain some valuable tools and make efficiency changes. For instance, Emory Healthcare came up with 30 just-do-it items, and one of these proved to be a valuable clinical trial readiness checklist.

Another rapid improvement event was related to a feasibility assessment of the protocol prior to it going through the IRB submission process, he notes.

It was a waste of time to have investigators submit protocols that had not been well thought out. For instance, the planned trial might not have a large enough subject population to complete enrollment or might be competing with a similar study for the same patient population, Bornstein says.

"That's a classic example of waste," he says. "People start going through the pipeline with the protocol and are a good ways through it with the IRB's approval, but then they never accrue any patients."

The rapid improvement event created a process for making sure early on in the protocol development that the study was feasible, and it involved the IRB director and a medical director. This particular project is ongoing, Bornstein says.

"Rapid improvement events are when you redesign a process for improvement over several days, as opposed to making changes over the course of months or years," he adds.