Biobank Sustainability, Process Streamlining and the Upstream Impact of Clinical Care

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Ann Nguyen:

Hi there. I'm Ann Nguyen, Senior Associate Conference Producer with Cambridge Healthtech Institute. Welcome to this podcast for the Ninth International Leaders in Biobanking Congress happening this October 25-27 in Nashville, Tennessee.

We're very pleased to have with us Kerry R. Wiles, Program Director of the Cooperative Human Tissue Network and Vanderbilt University Medical Center Tissue Repository at Vanderbilt University, which is the institution co-hosting the conference. Kerry is also one of our speakers and short course instructors.

Kerry, thanks for your time today.

Kerry Wiles:

Thank you for inviting me, this is very exciting to be able to talk about biorepositories.

Ann Nguyen:

We're looking forward to hearing what you have to say. Here's your first question: How did you come to build the Cooperative Human Tissue Network and what processes did you seek to improve using Lean Six Sigma principles?

Kerry Wiles:

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.

Ann Nguyen:

The biospecimen research enabled by well-run biobanks ultimately advances patient therapies in clinical settings, but the impact runs both ways. How do shifts in clinical care and even surgical care affect the biorepository and eventually the scientists?

Kerry Wiles:

I can give you a couple examples. Tumors at the point of resection generally are becoming smaller due to early diagnosis and detection. Therefore many of the procedures that are being performed are limiting the amount of tissue that we actually see as remnant tissue given for research to the biorepository.

For instance, we used to see a fair number of open radical nephrectomies in which we received the entire kidney, part of the renal pelvis where the ureter as well as the adrenal gland, and some deep tissue adipose fat. With the advanced surgical techniques and advances in imaging and early detection, whether that be from a blood test or an acute clinician, we see these more robot-assisted partial nephrectomies.

The result in that is that the remnant tissue availability for research has decreased greatly to getting just the tumor and surrounding normal tissue rather than the entire tissue. It sort of limited our ability to obtain those adrenal glands, or deep tissue fat, or the renal pelvis. It's really limiting the amount of tissue that the biorepository is seeing as remnant that's not needed for patient diagnosis.

Another example is we used to see five years ago radical prostatectomies or TURPs for BPH diagnosis. Now we're seeing more HoLEPs, which is holmium laser enucleation of the prostate. It's better for the patient certainly; there's reduced risk of infection, there's greater recovery, there's less time in the hospital, it's less expensive, it's less painful for the patient.

Again, with an open procedure we're basically getting the entire tissue as a solid form but with the HoLEP procedures they're basically enucleating with the laser the inside of the prostate. What we see now is just a slurry with very small chips of prostate tissue. For people that are doing morphological studies it's really difficult now to get BPH solid tissue, from at least our biorepository, due to these surgical advances.

Again, they're certainly much better for the patient, but they're also compromising our ability to further research. Sort of a heavy scale depending on where you sit. We certainly want to make everything very comfortable for the patient, and we want to ensure that patient diagnosis is successful, and we want to reduce the amount of time the patient is in the hospital, and certainly reduce the amount of pain. But it has taken its toll on the biorepository.

Ann Nguyen:

Just as biobanks need to keep many biological samples viable long-term through their storage functions, they also need to keep themselves viable long-term as a resource for scientists. What does it take to sustain a biobank and how might that change?

Kerry Wiles:

Sustainability is really one of those touchy subjects. It really does mean different things to different people. For example, I can have someone tell me that they're 100% sustainable and all their biorepository functions are supported through the recharge of their services. When you start asking questions such as, "What do you pay in rent? What's your electricity bill? How much do you pay in service contracts per year? What is your equipment turnover and who pays to replace that equipment?" The answer is typically institutional support. The institution provides us with space and electricity, and it purchases the startup equipment for us. When you delve a little deeper into their idea of sustainability, it doesn't match your idea of sustainability. For a lot of academic biorepositories it's very difficult to maintain and become sustainable, especially when you have indirect costs that are taking up 60% of your grant or your award and leaving you with 40% to operate. You're sort of forced to work a little bit harder to build that recharge so that you can support and sustain your biorepository.

Again, it's one of those very touchy subjects. Most people have different views of sustainability and what that is. When you're dealing with an academic biorepository where you may be taxed on any recharge income that you have for your service that you provided on top of your indirect charge, makes it really, really difficult to become fully sustainable.

I always like to question people on what they actually mean by sustainability. Also, it's part of the biorepository's responsibility to recognize trends so that you can stay ahead of the curve in sustainability. Part of those trends have to do with what investigators are requesting and where the research is going.

We've seen a dramatic shift from what we used to see investigators requesting in frozen tissue or formalin-fixed, paraffin-embedded tissue to now that shift being more for fresh tissue. Procure it the same day as the surgery and ship to them overnight in media.

They also want matching blood. I suspect that it's because the tumors are becoming smaller and smaller and more pharmaceutical companies and researchers are developing technologies that will detect circulating tumor cells or cell-free DNA in blood for diagnostic purposes or biomarker detection.

You have to understand sustainability, the business model, the trends that you're seeing and be able to adjust and be agile enough to move along that trendline and stay ahead of that curve so you can maintain some degree of sustainability.

This also delves into what we're seeing now with the new graduates that we're seeing and we hire. I've spoken to a number of different biorepositories and we sort of all have the same outlook with these new millennial graduates, in that their expectation of an entry-level job is around $60,000-$70,000 starting. There's no way that as an entry-level job in an academic biorepository you can sustain the repository with staff requirements, salary requirements like that.

What we see typically are they come in and they work for 12 months, or 18 months, and sometimes even 6 months. Then they realize that they're not going to be promoted in the timeframe that they think they should or they're not going to be making the money that they thought they should be making when they come out of college with their nice shiny degree, so they quit.

That costs the biorepository money because we spent all that time training, we spent all that money in implementing them and integrating them into the academic biorepository. That really has an effect on sustainability as well. This is one of the topics that we're going to talk about in the short course that we're hosting in October for the Cambridge Health Institute Ninth International Leaders in Biobanking conference held here in Nashville.

One of my co-presenters will be handling that topic at the University of Indiana. What she is doing to try to build her biorepository in terms of using staff and motivating them, creating titles for them, allowing them to be trained in a variety of different areas, so they can multitask and they can be promoted in a fashion that they're more comfortable with.

All of those things together really impact the way the biorepository operates and its ability to be sustainable.

Ann Nguyen:

Thank you Kerry for sharing your nuts and bolts and big picture insights about this field. We're really looking forward to hearing a lot more from you during the conference in October.

Kerry Wiles:

Great, thanks for having me.

Ann Nguyen:

That was Kerry Wiles of Vanderbilt University. She'll be representing Vanderbilt as a conference co-host, will be co-presenting with colleagues from the Medical Center on “The Academic Biorepository's Responsibility”, and co-instructing the short course Lean Six Sigma and the Biorepository - Synchronicity in the Simplest Form.

All of this is happening during the Leaders in Biobanking Congress taking place October 25-27 in Nashville.

To learn more from her, visit for registration info and enter the keycode, “Podcast”.

This is Ann Nguyen. Thanks for listening.