Vanderbilt moves towards a paperless cell therapy process: Four small steps for VUMC, one big step towards a digital transformation
Transitioning from paper-based to digital-based cell therapy systems benefits organizations by way of eSOPs, eBMRs, higher operator efficiency, and more. Read about the steps VUMC took to ensure success with their digital transformation.
Step by step. It’s how a marathon runner gets from point A to point B, it’s how award-winning chefs produce mouth-watering dishes, and it’s how Vanderbilt University Medical Center (VUMC) successfully moved towards a paperless cell therapy process.
But what exactly were the steps that VUMC took to make the transition towards paperless a success? In a two-part video series, Scott Sobecki, research informatics director at the Vanderbilt Ingram Cancer Center at VUMC, Katie Golden, laboratory coordinator at VUMC, and Per Hammer, senior product manager for automation and digital at Cytiva, discussed the steps, considerations, and lessons learned from integrating Cytiva’s Chronicle™ software.
The opportunities of a paperless cell therapy process
Paper-based cell therapy systems have been around for years. So, why deviate from the norm?
Like many medical centers, VUMC was looking to improve efficiencies in two key areas: time and space. And, their product processing report was running inefficiently in both areas. Though it’s paper-based, it has to be scanned in and stored on their file server, taking time and effort from technicians. ”If our process was electronic from the beginning, that step could be completely eliminated,” Scott noted.
And then the flood hit. Water damage caused binders upon binders of papers to be unsalvageable. And that highlighted a large gap a paperless solution could fill: streamlining the quality process. ”How do we make sure we're able to easily recover from a disaster, whether it's a fire, or a flood?” Scott mentioned as being a driving question. An electronic quality review process would allow VUMC to eliminate in-person contact – a relief for disaster situations where office access is limited.
Another key consideration: operator error. Standardizing the processes boosts efficiency and eliminates the challenge of illegible handwriting.
How do you move towards a paperless cell therapy solution?
Scott Sobecki recommends a gradual method. “We really wanted to take a huge leap, but we realized that taking a step-by-step approach was going to be the best way forward.” Scott later continued, “We found that being able to take this stepwise approach — much like you would in a Gantt chart or project plan – was really helpful in making sure we achieved our milestones along the way and got to the end in the quickest way possible.”
Step one: Barrier evaluation
The first step to a successful implementation is to understand and evaluate the perceived barriers of going from a paper-based approach to an electronic solution.
Is the solution costly?
“Initially we thought it would be a huge upfront investment,” Scott noted, “but we found that investment was mostly in time, not software.” Scott continued, “With some of the current technologies with cloud-based computing software as a service, that traditional model of buying a big software package is no longer something that you have to worry about.”
Is the technology difficult to use?
Another perceived concern that VUMC considered was the idea that they would need in-house experts to facilitate the transition. However, Scott notes, “We did most of [the transition] with our own team. So, having the right team makes a huge difference.”
Scott continued, “The perception that these tools can be very difficult to use is also not true. We were able to have a nontechnology-savvy person build these procedures, and have the technicians in the lab walk through them very easily with minimal training.”
Step two: Chronicle™ automation software adoption
Chronicle™ automation software is a versatile solution that can be implemented with an existing manufacturing execution system (MES). Plus, it offers a number of capabilities. So, Scott’s recommendation is to “Really understand everything that [Chronicle™ automation software] can offer, before digging in too deep to any one capability.”
And doing so was a successful approach for VUMC. “We found that being able to enter our instruments and consumables was something that was really easy to do, and that allowed us to begin using that capability with the lab almost immediately,” Scott explained.
Step three: SOP implementation
For this step, the key for success lies with the build out. To begin the build process, VUMC initially wanted to take the two SOPs of interest and build them out as-is — that is, to build them out on Chronicle™ software using the same process they would typically follow when building out SOPs on paper.
“But that led to one really big SOP,” explained Scott. To pivot, they took that one large SOP and broke it into 11 smaller steps.
Katie Gold elaborated, “Although the inability to jump around within an SOP was initially frustrating, we learned that it was actually a good thing – because it forces each tech to perform the same steps in the exact same order. Also, it gets rid of technical drift, and you know that every single task is going to be performed; nothing is going to be missed.”
Ultimately, VUMC took an iterative approach to building eSOPs. “We did this in collaboration with Cytiva,” notes Scott. VUMC would build the eSOPs internally, work through the difficulties they could on their own, and discuss with Cytiva the remaining difficulties and opportunities to improve the SOP process. “Then we would go back and rebuild our SOPs to leverage those new capabilities, which of course led to an iterative approach,” Scott said.
Step four: Test and validate
Once the system is up and running, it’s important to test and validate that the process is working. Scott suggests “doing this at the end, because we went [from one large SOP] to 11 smaller SOPs, all of which we had to do this same process with.”
Scott also notes, “One of the great benefits is that you have Cytiva to help guide you along the way, including the fact that they have the know-how. You can look at Vanderbilt and what we’ve done as a reference point for your facility.”
Considerations and lessons learned
“I’ve worked in the lab a long time, and I’ll be the first to admit that I never thought that a processing lab could go paperless,” notes Katie Golden. “But our lab was overwhelmed with paper, and we just needed to do something to improve.” She continued, “Although we’re not completely paperless yet, I do see us getting there eventually. We’re well on our way.”
Time savings
When discussing the numerous calculations performed throughout cell processing, Katie noted, “These calculations can be time-consuming, and if performed incorrectly, can lead to errors in reporting. Chronicle™ software performs all of the calculations, using formulas that were programmed into the eSOPs at development, and it requires very little data entry by our technologists. Because of that, the time savings are phenomenal. And you get the added bonus of knowing that your calculations are correct.”
Additionally, they were able to save time regarding auditing. “If you’re using a paper-based system, you know how time-consuming it can be to locate and gather all the documents you need,” Katie said. “As an electronic system, Chronicle™ software lends itself to capturing all this information.”
Space savings
”A lot of lab space was taken up by paper,” noted Scott, ”not only on the bench, but in binders and in file cabinets throughout our space. We already have a limited amount of space available to us. Being able to optimize for lab operations, and not for storing paper, is very beneficial to us.”
Compliance
As with any software integration, compliance is a significant consideration. Katie says it’s “important during cell processing to capture the identity of individuals performing significant steps. Chronicle™ software gives a date and time stamp along with the identity of the individual that performed each step, be it significant or not.”
Advice for organizations
Initially, Scott noticed the team transition from fear of new technology to confidence in automation as they began to work through the project. This led to the generating of new ideas and ways to use Chronicle™ software, but also brought them “to a point of being concerned with scope creep.” Scott’s advice? Be patient with everyone. “It can be quite the shock to the system going from a paper-based approach to an electronic one.”
Implementing a tool like Chronicle™ software is “truly a start of a digital transformation and really a journey that you will be undertaking,” according to Per. “But, as we've seen in the presentation, you can do this implementation in an agile fashion with one step at a time.” Per continued, ”I would even stretch as far to say that these types of tools will be critical for the success of the whole cell therapy industry.”
Ready to take the first step in your digital transformation? Contact Cytiva today to see how Chronicle™ software can help your facility.