That's a good question. I was actually recruited from Dr. Francis Collins's lab at NIH in 2002 to Vanderbilt to help build the repository. They had received the grant in 2001 and were just starting to lay the foundation for the repository. I was brought onboard to really try to build the program really quickly with very few staff members and even fewer dollars. I was lucky enough to be able to work on a couple of high-profile projects including the Human Genome Project at the University of Iowa, which really exposed me to large-scale projects with a lot of moving parts and a lot of data. Having that under my belt sort of prepared me to understand and really look at the need to organize data at different levels, understand the principles of project management, and operating on a tight budget. We were expected to do things really efficiently and that was the basis for how I built the CHTN Western Division. My focus was really on building an IT solution that would allow us to do our repository work and get up and going really, really quickly. In 2007 when the economy took a turn for the worse, we were expecting cuts, we were expecting our investigators to experience those same cuts. We knew we had to operate with much less. Began looking at what other companies, Fortune 500 companies, were doing to try to operate as leanly as possible, and it really got hooked into the philosophy of Lean Six Sigma, which is basically a way or philosophy of eliminating waste. Waste can come in a variety of different forms: waste in movement, waste in materials and consumables, waste in time, and certainly waste in money. We knew we had to do something to kind of keep our operations very tight and controlled in order to not have to let anyone go due to the economy. That was really my first foray into Lean Six Sigma and trying to use it in a biorepository setting. Just a quick example of how this has kind of helped us streamline things using this methodology and these methodologies, we had CAPA reports, which were basically PDF format. It documents the staff with download when errors occurred. Trying to get the staff to actually download those documents, fill them in, and then send them to me was a struggle. They just didn't have the time. Even more compounding was the fact that I would have to review all these documents and try to segment them into critical, major, minor, or severe HIPAA violations. That process in itself, being a busy director for the repository, it took a lot of my time and it's time that I didn't have. One of the things that we strove for was to build within our repository IT solution and error reporting modules. This was used under the Lean Six Sigma framework and trying to really streamline and minimize the wasted time of our staff and myself. We basically built the error reporting module in our IT repository system. When an error occurred, staff could report it directly within the IT solution by using dropdowns, locate the area that they think the error occurred, how it occurred, what operational impact it had, if the error had been fixed or if it needed to be a pending error until somebody could review it and fix it, then a brief description of how they think our operations could be changed or SOPs could be changed so these errors wouldn't happen again. Once they hit that submit button, it automatically distributed the error to the area that they felt the error occurred in, and I also got that email, and so I could very quickly assess whether this was a major, minor, or critical error and take care of it really quickly. That whole process of CAPA, the Corrective Action Preventive Action, was cut in half to just minutes rather than 20 minutes of filling out a form and mailing it back and forth. That's really the basis of Lean Six Sigma and how it can be used to minimize waste. |