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Now, I have the great honor of introducing myself. And so, I'm gonna give you an update on the Novalis Certified Program today. How many have you have heard about the Novalis Certified Program? Cool. And as I look around the room, I see at least five sites, five institutions on four continents that I know have been certified. So, that's outstanding, and then I know the rest of you are in the process of working on it. So, I'm gonna try to help you through that a little bit today. Yeah, so I have a few things. I really like this survey. This was done in the United States. You're looking at practice patterns and safety in general radiation and oncology. So, this was a survey of a number of institutions. I got 114 responses.

You can see some small institutions treating as few as eight patients a day, and some large institutions treating as many as 600 patients a day. There are not very many of those. And so, they scored different questions and categories from one to five based on whether you strongly agree or strongly disagree. And I just want to highlight a few things. So, the highest levels of compliance, not surprisingly, were all physics-related because we're very compliant people. So, we make sure we calibrate our equipment. We make sure we do pre-treatment verification. We make sure that we follow our regulations as regards to radioactive material use, and we do our chart checks, our initial chart checks, and our weekly chart checks.

So, very compliant. Highest levels of compliance among physicists. The lowest levels of compliance. And now it's a little bit scattered, but the lowest ranking item was a time out before we treat. So, a lot of us aren't doing time-outs, or a lot of our therapists aren't doing time-outs. We don't have standard operating procedures for a lot of things. We don't do an independent review of some things, even though I think as physicists we know we do that. Physicians don't...we don't do peer review for physicians or our treatment plans. I think that's not surprising. And a lot of departments still don't track their [inaudible [00:02:46.243] which is unfortunate. So, not surprisingly, the items that are most compliant were the things that...oh, sorry, had to do with regulatory aspects or billing. If there's money involved, we're gonna make sure we're compliant and we do it. And the least compliance related to activities, unfortunately, that we've known in the past have contributed to serious mis-administrations. So, even though we know about those, we still have a ways to go in terms of our practices to try to prevent them.

So, what's kinda neat is the world is getting safer, at least in some industries. So, if we look at air travel, we're all pretty...most of us flew here, so we're grateful that air travel is safe. And as you see, the number of passengers goes up and up and up, and yet the number of air accidents, air-related accidents, goes down, so that's a really good trend. What do we think about it in our profession? So, we know we have errors in our profession. Medicine, let's call it medicine. At least in the United States, I don't know where some of you guys are from, but we have errors in medicine in the United States. Enough of them that it's actually the third leading cause of death, preventable medical errors, in the United States. And unlike air travel, unfortunately, if you look at the estimates of that from 1993, from the early to mid-90s, somewhere around 100,000 or so. Now that seems to be going up. So, the complexity of medicine is going up. We're getting busier and busier, and we're making more errors.

We know in our profession, in radiation therapy, there have been a number of serious errors over the years, over the decades, including more recently some of the ones that you know about. So, there's a need to try to minimize those. I think with regard to our practices, and with regard to our Certified Program, probably the most important aspect, of what we do in the program, is having a just culture. So, a just culture recognizes that we do make mistakes. We're human. But we want to have processes in place so that we can catch our mistakes, and then those mistakes that we do make don't lead to harm. We know the greatest single impediment to minimizing errors is that we punish people for making mistakes. So, we have this philosophy in Novalis Certified, we have this philosophy at my institution that we don't punish people for honest mistakes. That exacerbates the problem. So, we want a just culture. A just culture makes it safe, and we know that occasionally we make errors and we hope that they don't lead to harm.

As opposed to at-risk behavior, so this is behavior that we engaged in, of course, that can be risky and then, of course, reckless behavior. So, honest mistakes are fine. Reckless behavior isn't fine. And this young gentleman learned the hard way what can happen when you engage in reckless behavior because he fell. Right. So, let's skip through that. So, with that kind of as the background, the Novalis Certified Program was established in conjunction with Brainlab, and largely independently to try to set a standard for the safe and effective practice in SRS and SBRT for sure, and also to minimize errors. There is no other program like Novalis Certified. Some of you in your countries have some certification programs that we do in the United States, and those are general programs. They don't address SRS and SBRT specifically, and of course, we know we're giving high doses in few fractions. There's very little room for error.

Many of the organizations, professional organizations from the IAEA to the World Health Organization to Astro, all recommend independent review and independent credentialing kind of programs and processes as part of our ongoing quality assurance. And just some of the references that the Novalis Certified was based on. So, when the program was developed, the people who organized the program looked around, took the best available recommendations, guidance, etc., from the literature. Not just from the United States, but throughout the world. And so, here are some of the documents that those are based on. Okay. So, with that background bit, the group developed what's called The Novalis Standard. It's a 20-page document. It's now translated in many languages, a 20-page document that lays out the expectations of what's involved in meeting the requirements of the Novalis Certified Program.

So, some of the requirements, you want to have a well-thought-out program. I think all of the presentations we've seen this morning, and maybe yesterday as well, really reflect that people are really thoughtful in how they approach SBRT. We're all physicists. We know that sometimes the physician will say, "Hey, I got this pancreas patient, and I've got no other options for them. I really want to give, like, two high-dose fractions on Monday." And that's the approach that we don't want to take. Right. We really want to think through this carefully.

You need a very robust quality management program. I think most of us have those, you know, with elements of management, regular meetings, documentation, how you distribute the minutes and results of the documentation. Peer review, whether it's reviewing each other's plans, or reviewing each other's patients, etc. External audits like this, and incident reporting system. And we saw from early on that despite the fact that we know that incident reporting is really useful, still, a lot of us aren't doing that. As an example, and I'm gonna show you a number of examples, and all of these come from centers that have been certified in the past. So, as an example of peer review, this particular institution has a neuro spine conference, a lung conference, a multidisciplinary tumor board, patient consultation with multiple specialists, etc., etc. And so all of these kinda things where all of the individuals get together, talk about course of treatment, talk about how a patient's done, review each other's work, really essential part of ensuring high quality.

Policies and procedures. This is...there's a couple of areas whereas institutions start to embark on this process, they go, like, "Oh my God, this is gonna be a lot of work." So, I think many of us have policies and procedures written for many things. Some of us maybe are lacking in some areas, so it may require generating some policies and procedures. But again, we really want to see that your program is well-thought-out and that you, you know, you have thought about what you're doing and you follow it.

Clinical guidelines. So the group that evaluates this eventually consists of neurosurgeons, radiation oncologists as well as physicists, and we want to make sure that people are practicing within what we consider a range of care that's standard. Of course, there's a lot of room for diversity within that, but there are outliers too. So, we want to make sure, as an example, catch any outliers. And so, perhaps somebody might be treating acoustic neuromas in a super-fraction of 18-gray. That would probably trigger some discussion about that particular kind of dose. The same for SBRT. So, this is an SRS/SBRT program. You're going to see some examples from centers, and just their general approach to these kinda things. We want to make sure that you have the right number of staff, that the staff you have are properly trained and credentialed, that you have job descriptions, and that you have ongoing education programs.

We want to make sure that you have the right equipment. In my career, I've certainly been in a situation where they buy you a new $6 million machine, and then you ask for a stereotactic diode and they don't have the money for that. So, you know, it's not just the machine, but it's all things that we need in order to do our job properly. Right. So, those are some of the elements, and now I'm just gonna take you through the process a little bit. So, it starts by having a reviewer assigned to your site. A reviewer works with you, provides you with The Novalis Standard, with lots of documentation, with lots of examples that I'll show you. The first thing we ask to do, the site to do, is to fill out what we call a self-study. It's just fill-in-the-blank. So, you know, what do you treat? Who are your personnel? Are they trained? What kind of equipment do you have, etc.? And then along with that, then is the accompanying documentation of your site-specific protocols. I'll show you some of the policies and procedures. And of course, physics [inaudible 00:13:06.824].

I'll just show you a couple of examples. Again, you know, physicists tend to be pretty compliant people, so we have pretty good documentation for what we do. Often what we find is lacking is the same well-thought-out approach to how we approach patients clinically. So, just a couple examples of some of the site-specific clinical guidance documents that people have...that we've observed out there. So, here's one for the treatment of lung metastasis, or, sorry, early-stage lunch cancer. So, first of all, why do you want to do this? Why do you want to start a lung SBRT program? Well, we know if we do it well that the patients have a 90% rate of [inaudible 00:13:55.929]. So, you know, why do we want to do it? What patients are eligible? What patients are ineligible? How do we work them up? Pulmonary function tests, staging PET scans, etc. So, how we work them up, so we know this patient is appropriate for SBRT. And then, of course, how do we image them for the purposes of treatment? How do we manage motion? How do we create our PVTs and so on? How do we define our OARs?

What are our prescription doses, and again, you can see, you know, as a function of size they may have different stratification for our doses. And what are our constraints? So, this particular example for lung SBRT was about eight pages long. This is a pretty extensive example. I'll show you a little bit shorter one for spine. And again, these all come from sites that have been certified. So, here's one for spine. It's about four pages long, but the same kind of content is there. Why do we want to do this? What patients do we want to treat? And what patients shouldn't we treat? How are we gonna prepare the patient for treatment? How are we gonna plan them? How are we gonna image them, etc.? This one looks nice because, of course, it incorporated some elements from the literature about how they're gonna define their target volumes.

So, prepare the self-study. Work with a reviewer to go through that. Submit the self-study and other documentation. When the reviewer...some places this takes a couple of months, some places it takes two or three years. That's fine. The reviewer is there to work with you through the process, back and forth, whatever assistance you need. Then there's a one-day on-site review, and that's really an informal process meant to kinda get a sense of the culture of how you're staff interact with one another. We observe some treatments, and again, see how your staff interacts throughout the process of the treatment. The reviewer then writes a fairly extensive report and gives that report with some recommendations to this group, who are called the experts.

Again, neurosurgeons, radiation oncologists, and physicists. And those experts that review. They provide some feedback. Finally, the report goes to the center, and you pass. So, so far nobody's failed. I think we have 45 centers throughout the world that are certified. Maybe the last comment I want to make on this is as much as possible, it's independent from Brainlab. So, Brainlab never sees the report. Brainlab never hears what the experts have to say. It's completely independent.

Yep, and so here we are. Again, I think we have 45 sites certified. Many sites in the process. We're working with a number of you, and a number of you that we're not working with are certainly interested in getting involved in this. So, thank you from San Francisco, and now...