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There has always been pressure on the Histology Lab to do more with less money, less people and less time. Automation in Histology has somewhat stalled over the past few years and is difficult to implement. Automation is only a multi-disciplinary process to integrate manufactured machinery and software to perform manual tasks that will allow the lab to capitalize on technology that will provide new and improved processes, increased quality and, most importantly, improved patient safety. The continued evolution of innovation in Histology, both sustaining and disruptive, has taken us from inferior processes to replacement with superior processes. So, why are these processes so critical to success? Developing Innovative Solutions is a demand of the patient and embraced by your management. This workshop will provide learnings/outcomes from implementation projects and identify opportunities for success and will provide the attendee a new understanding of how automation/ innovation can move your lab from niche application to integrated process.
- Identify opportunities for automation
- Formulate automation/innovation solutions
- Develop improvement processes
William N. DeSalvo III has 40+ years of experience in the Anatomic Pathology field, 36 years as a Registered Histotechnologist (HTL) by the American Society for Clinical Pathology (ASCP), 11 years as a Clinical Histology Laboratory consultant and 12 years as a Product/Marketing Manager. He earned a degree in Biology/Chemistry from Southeast Missouri State University, received training in Six Sigma and LEAN methodologies for process improvement, an active practitioner of continuous process improvement, process improvement consultant and has developed a Quality Management System for the Histology and Anatomic Pathology laboratories. For the past 15 years, he has provided educational presentations and published multiple articles on process improvement, standardization and automation in the Histology laboratory to organizations and laboratories located in the USA, Canada, Europe, Japan, South Africa and Russia. He is currently working as an Anatomic Pathology System Manager, Consultant, Editorial Staff Member (Clinical Laboratory Products), Clinical Coordinator and Adjunct Faculty for the Applied Sciences Histotechnology Program for Phoenix College and has previously volunteered as an Executive Board Member and Membership Committee Chair (Digital Pathology Association).
I hope we can have a little bit of a discussion about automation and innovation, but what I want everybody to do right now is just look at that first slide that we have here from Leica Biosystems, Vision 24. That's exactly why we're going to talk about automation and innovation. This is what our patients have an expectation of us in the anatomic pathology lab.Within 24 hours they want results, they expect results, and as you know it's all those little boxes up there. They want some very detailed data and information from us. So, this is why I've been involved in and have been trying to make sense out of what kind of automation works for us in the histology lab and those other innovative tools, which most of you know as LEAN and Six Sigma, and they're even expanding past that. Let's get started with some of the other slides and see where we go.
Our learning objective today is to identify opportunities for automation. All of you should be well aware that’s some difficulty for us in the pathology lab. We’re a very manual multi-step, multi-critical task process. There are opportunities.We want to evaluate automation and innovation solutions. Again, there are multiple opportunities and multiple solutions here.This is why it's so difficult for us, and our third learning objective is to discuss improvement processes, because automation and some of these tools that have been around for several years will not help or fix all of our issues and create a better patient safety environment. It's a discussion as I’ll call it.
So our first one is histotechnology today, and there's even been a couple of articles out recently.We are a 150-year-old process. What we're doing today in the histology laboratory, even with all of the new instrumentation and everything else, that process is over 150 years old. So we have a conflict of need and to our current processes. This is my own little timeline that I have put together for my time in the lab. When I started in the clinical lab we were basically doing a diagnosis. That was it.As you can see, we had H&E, some special stains. We had diagnosis, then we moved forward to the differential diagnosis and IHC and then we started adding molecular, a little star here basically is that's when companion diagnostics came out and I hope all of you have heard about those companion diagnostics because that seems to be the new opportunity for us in pathology and our participation in cancer management.
Then, in 2011, we created that only with the probes, but then in my particular situation, NextGen sequencing became pretty much a standard in the clinical diagnostic process, which involves pathology. Today we moved from the digital pathology system that has now been FDA approved that finally brings us in the US to the rest of the world, and we have a system that can be used in the clinical lab. It’s not that much different the system and/or the new systems that come about. They’ve been used in there search and in other areas other than a clinical primary diagnosis.
All of this takes us from a specificity and sensitivity process, and again the acceptable type of result was developed. The process was developed in 150 years ago, and now we're being asked to do much, much more with our process. That leaves us to, where do I start?What is the demand, what is the need, and I will tell you it’s being patient-centric, being patient safe, and patient quality.Each and everything we do in the lab if it's not tied to that I will tell you, why are we considering? So, with that timeline in mind,the tried and true, but old process that we have and I think everybody needs to understand, we provide very good and accurate information. In my mind, how much longer can that be true?
So, there is many opportunities…there’s types of automation in histology I would venture to guess that all the participants are using some sort of automated immunohistochemistry. My issue with starting there is that that’s at the end of the process. And there are so many things from the selection or taking of the tissue sample to getting to IHC, but that seems to be the trend for the last15, 20 years of my experience in the lab that automation as it comes out and becomes available, and it becomes affordable to us in the histology lab, typically it’s designed to be at the end of the process. The newest automation for the clinical lab is digital pathology. That’s at the very end right before and replaces that delivery of the slides. Everything seems to be skewed to the end and then it creates its own issues.
Types of innovation in histology are, how do we move from conventional tried and true methods to more small batch and rapid—and that seems to be the term everybody uses—rapid processes. It is, and there is a lot of truism to the fact that if you move into smaller batches you have a better control of your quality, quality control, and your quality assurance which leads to improved patient safety and results. Most use automation in histology. I would say the two are number one your IHC stainers and then your H&E stainers
The other innovation with the H&Estainer that has come about is that the vendors quickly have learned how touse one of the innovative tools of co-location to bring two critical tasks or two methods and processes together,they added some robotics and now a lot of us have H&E strainers that not only stain, but then move right to cover slipping, that’s the co-location.The new automation is automated and betters are coming at us, new microtomes, more of the automated microtome and there will be many more opportunities and offerings in digital pathology, so that’s the type of new automation that is coming at us.Stop and think for a quick moment.How am I going to put that in to my laboratory? It’s difficult and it’s hard, it's expensive, and there is a process that you have to go through before you decide to purchase these instruments. In the last… in my career. We went from $20,000 to $40,000 for a piece of instrumentation to $200,000+ for a piece of instrumentation.
Wow, where am I going to come up with this? It has a return on investment, but it has to have a lot more thought. So, you have to focus on how you're going to connect and integrate a piece of automation with the rest of your manual process.But all of that, where you decide to start where you decide to change from manual to automation will all help you become more patient-centric because anytime we remove a manual task and replace it with automation and/or connect extra automation, it will improve the quality, it will improve safety, which means our ability to confirm that result as the pathologist continues to perform their review of the information and release it out to our clients the physicians, and then ultimately our primary client, the patient.
Four types of automation
There is lots of opportunities and I will tell you, I don't have the answer of where we start. Each and every lab is still so diverse and different. It is a discussion about where you're going to start at and/or what your next step in automation will be.When we look at the automation, we also as I just spent the last couple of minutes talking about only instruments. There are really four types of automation that we need to talk about. Yes, absolutely instrument automation is necessary for us to get out of the tedious and repetitious manual tasks. But then, communications. By communications I mean how is that instrumentation connected and tied into your