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Ethan: Hello, everyone. This is Ethan Province, Regional Marketing Manager for Brainlab. And we thank you for joining our next Novalis Circle Clinical Webinar. Today we're gonna be discussing the Novalis Certified program. This is a certification specifically designed to address the safety and quality of radio surgical procedures. Today we have the pleasure of hosting two speakers. Sorry about that. We're gonna be hosting two speakers. First, we have Dr. Timothy Solberg, Professor and Vice-Chair and Director of Medical Physics at University of California San Francisco Medical Center. He's on the Novalis Certified Expert Panel and is gonna give an overview of the program and speak to some of the unique challenges encountered when delivering SRS or SBRT treatments. The second speaker is Jonathan Howe, Medical Physicist at Norton Cancer Institute at Louisville, Kentucky. And Norton was actually the first hospital in the U.S. to achieve certification. And Jonathan's gonna offer us some insight into his experience in participating in this program.

So as for a little housekeeping, if you have any questions for either speaker during the webinar, please go ahead and type them into the chatbox on the right-hand side. And we're going to host a Q&A session to answer all those questions following Jonathan's presentation. So with that said, let's go ahead and get started. So Dr. Solberg, thank you for being here today.

Dr. Solberg: Thanks so much, Ethan, and welcome to all our Novalis colleagues throughout the world. This is a really exciting webinar for me, and I think a very exciting webinar and opportunity for all of the Novalis users throughout the world. I'm really excited to talk to you about this. And as Ethan said, we're gonna talk about the Novalis Certified project. And it's a very, I think, important and attractive project. Many centers are coming online. Just to give you some disclosures, I am a member of the Novalis Certified Expert Team. You'll hear a little bit more about that in my talk. I am one of the auditors for the process and I do some lecturing for the Brainlab Academy.

I think we're all aware of some of the shortcomings that have occurred over the past decade or so in our field of radiation therapy, and some of those which have specifically pointed out some deficiencies with regard to SRS and SBRT. Whether they're systematic problems in measurements and calculations or kind of one-off problems where people have treated the wrong side, forgotten a cone, etc. So there have been a number of well-publicized errors. And I think maybe more importantly, there's a real need to standardize, not just eliminate errors, but standardize the whole radiosurgery process at a universally high level. And so that's what the Novalis Certified process is. It's a formal program for standardizing SRS and SBRT at universally high levels so we can maximize the clinical efficacy, minimize complications, and ensure the highest quality, and of course, prevent these errors that we've all heard about. So it's a certification process specifically for SRS and SBRT. And depending on where you are in the world, you might say, "Well, don't we already have some credentialing programs?" So for example, here in the United States, we've got the American College of Radiology program. We've got the ASTRO program. And so certainly in locations where you are, you may have some other certification or credentialing programs. So we certainly do have credentialing programs in radiation oncology, but that said, there are no specific credentialing programs for stereotactic radiosurgery and SBRT. And further, most of the programs throughout the world and certainly the programs in the United States, the ACR and ASTRO programs, are voluntary. And unfortunately in this country, only about 12% of radiation oncology programs in the country have elected to undergo this voluntary certification. So the Novalis Certified program fills a very critical gap. That is, there are no specific SRS/SBRT credentialing programs. That's why the program was designed.

In general, why would we want credentialing programs? And specifically, why would we want SRS and SBRT credentialing programs? Well, we have numerous documentation, publications, guidelines, recommendations, sometimes even regulations that point to the value of a credentialing program and aspects of a credentialing program such as independent external audits, of which is a part of the Novalis Certified program. So the International Atomic Energy Agency has said that independent audits are a really necessary part of the QA program. And that those audits should review all aspects of the program. So that involves staff, equipment, procedures, safety, and overall performance. The World Health Organization has stated that frequent audits and peer review processes of specialty programs are important in preventing errors and in elevating the quality of radiotherapy. And then of course in 2012, the U.S. organization, ASTRO, published their bulletin, "Safety is no Accident," again, emphasizing the importance of independent reviews or external reviews. And that particular document specifically recommends creation of mechanisms to support these kinds of reviews for special treatment techniques including SRS and SBRT. So we have a lot of guidance that tells us that peer review, independent audits, independent reviews are really valuable, and including for specialized procedures like SRS and SBRT.

So several years ago, Brainlab recognized that there was this gap to fill and convened a group of radiosurgery and SBRT practitioners and had them sit down and draft a standards document. We call this the Novalis Certified Standards Document, that would help them develop this program to ensure the highest standards and consistency. And I've underlined on this slide that this is set forth by an international panel of experts. On this expert group, there are people from Europe, there are people from Asia, and there are people from North America. This is not a U.S. program, it's an international program. And the guidance that's been assembled to support this program is international guidance. I mentioned earlier the World Health Organization, the IAEA. There's Towards Safer Radiotherapy which is a very important publication coming from the UK. The ASTRO bulletin as I mentioned from 2012. And then many, many other documents. ACR-ASTRO guidelines, AAPM Task Group Reports, and other examples that I have here. The UK SABR guidelines, RTOG protocols, Clinical Literature. All of these documents were then assembled and consulted by this expert panel in developing the Novalis standard.

I specifically want to re-emphasize again that this is an international program. So it follows standards and regulations from the local country and it doesn't impose unreasonable expectations. So if a center in Chile, South America, for example, wanted to be certified, we would not impose those kind of standards from Western Europe or from United States on a South American center. I also want to emphasize that the program is independent of Brainlab. That is Brainlab doesn't participate in the review. Brainlab doesn't receive any of the reports from specific sites. And Brainlab is not involved in the decision whether to certify a site or not. All of those things rest with the reviewer and with the expert panel. And then just as additional comment, the site is not expected to use solely Brainlab technology. What the reviewers and the experts wanna see is that the technology is deployed appropriately. And that may mean in many settings that a center uses technology other than just that from Brainlab.

So all of that then information went into the development of this Novalis standard. The standard is revised regularly. It's currently being revised again. This is about a 20-page document. Brainlab will provide this to anybody who's interested. And these are kind of the elements that the standard calls out and that a reviewer will look for when they do their review. The organization and infrastructure, policies and procedures, and documentation, personnel requirements such as training, staffing, credentialing, and then technology requirements, and QA requirements. And I'll go over each of those in a little bit of detail. So first of all, program organization and goals. We really like to see that a stereotactic program is well-thought-out, well-organized, and systematic and not really an afterthought. So in other words, we just don't say on a Friday, "Well, I've got this patient, and we should really treat them with SBRT to the long run Monday." So we'd like a lot more forethought put into the program. It's important to understand why a site wants to provide stereotactic services. I have a little clip from a center in Europe and you can see that this is a large regional center. They have a number of oncologists and so on. And there was a need in this region of Europe for a stereotactic program. And so you can see the justification that they've provided for developing such a program. And of course, we want to see that there's a commitment to dedicating the resources that it takes to deliver SRS and SBRT at the highest levels. Because, of course, it does require additional resources.

There needs to be a formal quality management program. I think this is essential part of any discipline in medicine, and certainly in radiation oncology, and certainly part of stereotactic programs where you have somebody who's identified as a QA manager. You have regular meetings of this quality assurance committee. You have documentation of the things you discuss, and the actions that you've taken. You regularly review and update your policies and procedures. You do things like failure modes analysis. Peer review is a really essential part of a quality management program. Both internal peer review and external peer review, we'll talk about that a little bit more. External audits such as a Novalis Certified program are a really important part of the formal quality management program. And incident reporting and incident learning, learning from your mistakes and learning from your near misses are really important part of a quality management program.

And of course, our colleagues in Europe have a couple of standardized reporting systems. We now have one in the United States that's run through AAPM and ASTRO. But many centers may have their own incident reporting systems. And then finally, what I like to call the culture of safety, and I'll spell out some of those aspects on this next slide. You know, the culture of safety is an organizational culture that acknowledges you have high-risk activities and you're gonna do everything you can to consistently be safe in those high-risk activities. Most importantly, a blame-free environment where individuals are not afraid to speak up, to report errors, to make suggestions, to take a time out, collaborating across all the ranks of disciplines. So physicists, physicians, therapists, dosimetrist, everybody so that you can understand any problems and have a safer environment.

Peer review. There's many documents in the literature talking to the value of peer review. I've listed some references here at the bottom, just talking about the value of peer review in radiation therapy and in stereotactic programs. Peer review means you've got a group of peers, people who are of the same background as you and you're open to having your decisions evaluated, and perhaps questioned and perhaps changed. And peer review comes in many different forms. Most of us have different series of conferences and rounds in our departments. And I'm just showing you a screen capture from one of the sites that was certified showing you some of their peer review opportunities. Whether it's a lung conference, a planning conference, a mortality and morbidity conference, and so on and so on. All of these are open to everybody and give everybody the opportunity to comment on the course of care for any particular patient. So peer review's a really essential part of these programs.

Policies and procedures. So not to be too onerous, but it's really important that policies and procedures are well-written and well-documented so that anytime anybody has a question, there's anything out of the ordinary, you can always point to your policies and procedures and say, "No, this is how we do things and this is why." And that ranges a large spectrum from planning directives, to clinical protocols, to how you manage motion, and of course, on the technology side, your policies and procedures for QA and for machine commissioning. You can just see again on the bottom, of course, this would have been one of the institutions in a German-speaking country, but you can see some of the policies and procedures or an example of a policy and procedure that's been developed. So this is a really critical element, the policies and procedures.

The clinical guidelines and clinical guidance. So the reviewers certainly want to see, is the way that radiation therapy and stereotactic radiotherapy being practiced isn't within the range of what's really considered the standard of care? And of course, there's a big range of standard of care. One center may treat acoustic neuromas in 28 fractions, that's certainly appropriate. Another center may treat them in one fraction, that's certainly appropriate. But what we really wanna see is that there's some justification for how the center has decided to treat different indications. That the justification is supported by literature. And that those indications are treated within what's considered a range that's a standard of care. So this is part of a document we call the self-study. I'll talk a little bit more about that in a minute. But this is just something that the site prepares ahead of time and fills in to give the reviewer an idea of how things are being done. That was for cranial indications obviously and this is for extra-cranial indications and then the lung, spine, etc.

Personnel. It's very important that there is adequate staffing. And that means not just physicians but therapists and physicists, etc., in general. If you wanna start and run a stereotactic program, it does require additional resources. Are those personnel properly trained both on their internal procedures as well as on the equipment that they're being used? Do they have job descriptions? Is their competency evaluated routinely? And is there a credentialing process in the institution for when you get a new employee, how you train them to be competent at those tasks?

Of course, technology is a huge part of any stereotactic program. So the reviewer will want to see, do you have the appropriate technology in place? And not just the delivery of technology but the planning system, the dose algorithm in their planning system, the imaging modalities, the appropriate measurement tools, dosimeters. So we want to see that technology is being used appropriately, that the appropriate technology is in place, and then along with that, that the appropriate commissioning has been done for stereotactic programs. That there's some realization that this end-to-end testing is really important to ensure that we can deliver the right dose to the right location. And also that there's some independent verification of how we calibrate our machines. And that can take many forms. Maybe the country has a standardized dosimetry lab that does this independent verification. Or maybe you just have your colleague from the neighboring town come in, make an independent measurement, and say, "Yep, your machines are calibrated properly."

So those are some of the key elements. And now I'll just take you through the process of becoming Novalis certified. There's a self-study template. Again, Brainlab distributes this to anyone and everyone who's interested. And at a point early on when a center is interested in becoming certified, they'll begin working with the reviewer. The reviewer will work with them to help fill in this template, to help assemble other documentation, and this process can take between over a month and years depending on the resources that the center is putting into it, how much work they may need to do in advance of this. But the important point here is that we try to give you all the tools to put this documentation together in an expedited fashion. And so this reviewer will work through the self-study with you and will work with you for as long as it takes in order to complete the process. Along with this self-study, which is about 20 pages, and you can see the kind of things that it's asking for. Who are your personnel? What technology do you have? What are your clinical processes? Along with this, there are gonna be some appendices that go to the policies and procedures I mentioned earlier on each of the specific aspects. Whether they're clinical aspects, general employee human resources aspects, or technical aspects. And again, the reviewer has a lot of material at their disposal to provide you as examples and to help you through the process.

Let me just show you a couple of these clinical guidelines that I'm referring to here, these site-specific protocols for either cranial, radiosurgery, or extra-cranial. And again, these are examples that came from sites that were subsequently certified. So this is for lung SBRT obviously. And the center goes through a little narrative about why they want to do lung SBRT. And fundamentally, they wanna perform lung SBRT because it's effective. They expect if they do things appropriately, that they can have high levels of local control in these patients with early-stage lung cancer and lung metastases. So this is kind of the rationale for why they're beginning this lung SBRT program. Of course, there are indications and contraindications for patients who may not be able to have this procedure. There are pre-planning tests. So we want a lung function test. We want a staging PET scan perhaps. We want a contrast CT. Of course, we want pathology. So all of this is in the initial workup to determining whether a patient may be appropriate for lung SBRT. And then there are the treatment aspects, how we position the patient, how we do the imaging. Maybe we do a 40 CT scan, how we manage motion perhaps. This particular center talked about how we do define our target volumes. So we wanna use certain window and level to identify our target. And here's how we make our GTV with including some internal motion.

This site talked about how we define our organs at risk. So again, there may be certain windows of low levels on our CT scan, or how we define the central zone as opposed to the proximal zone as opposed to the peripheral zone, etc. How we do our treatment planning, what kind of dose coverage and hotspot specifications we want. So they want a maximum dose, it's not over 140%, for example. The fractionation schedules. So here, again, in a little more detail is what we had in that self-study. Well, for small tumors, we'll use 3 times 18. For larger tumors, we'll use 5 times 11. And for central tumors, we'll use 8 times 7. So this is a really nice well thought out clinical guideline. What kind of constraints do we use? So among the 20 min lung dose, etc. Here's some additional constraints for chest wall, for ribs, etc. And then finally, how we follow up the patient. And some of the references that were used to generate this document and to determine how these patients are gonna be treated. I actually like this part because they even included it in this document, one of the versions of the CTCAE toxicity scores.

So that's one example from one center. Here's another example from another center on site-specific guidelines. This, of course, for spine. And again, the process is somewhat similar although not quite as elaborate as the last one. You know, what's our motivation? Well, we should be able to get better local control, more durable palliation if we treat these eligible patients using this technique. And so what patients are eligible? What patients are not eligible? Again, how do we work these patients up? How do we image, plan, define our targets? What are our dose constraints and so on? And then of course, obviously with spine, there's always the issue that you may be re-irradiated, sorry. And so in that case, the dose and number of fractions may be modified somewhat. And again, I like this one because they included the consensus target volumes that had been published from one of the consensus groups. So this one was about four pages, the lung one was about seven pages. And these are just really nice examples of the clinical protocols that we'd like to see in place.

Okay. So just a couple of slides left and I'll turn it over to Jonathan. What's the process? So an institution informs Brainlab, "We'd really like to be certified." And then the expert group working with Brainlab assigns a reviewer to the site. And this reviewer works with the site very closely. As I mentioned, the process may take a month, it may take a year. And whatever it is, this reviewer is in frequent contact with the site helping them through the process. The site will submit the self-study and the appendices that we went through. Once a reviewer feels that, "Yep, things really look good, all the processes are really well-defined and in place," the reviewer will come on site for one day review. This is primarily just to observe the interaction with the different team members to review any documentation that could be reviewed ahead of time and just kind of see what the culture is at the institution. At the end of that, the reviewer will complete a report. It's very detailed. This will be provided to the institution. If there are any things that require follow-up, the reviewer will ensure that those things are completed. And there's always some recommendations that go along in the report. The reviewer provides a recommendation to the expert group. And then the expert group determines, "Yeah, the site should definitely be accredited or maybe there are a couple of things that still need to be worked on." And if that's the case, the expert group says, "Yeah, why don't you go back and work on a couple of things?" Then this process just repeats with the reviewer continuing to work with the site. Yep. So just to highlight that, the reviewer is your colleague. He or she is one of you, a physicist or radiation oncologist. He or she will guide you through the process and help you and advocate on your behalf. So to date, we have over 160 sites who have registered for the program. We have nearly 40 sites that are certified, and something like 115-120 sites still in progress. And I think we're getting more and more sites all the time.

So with that, I'll say thank you. I know there are probably questions of which we're leaving till the end. And I will now turn it over to Jonathan Howe. As Ethan mentioned, Jonathan's center, the Norton Cancer Center in Louisville Kentucky, was the first U.S. center that were accredited. Jonathan has subsequently become a reviewer in no small part because his center was so well-prepared and so well-organized and is really a model for Novalis-certified centers. So I'll turn it over to Jonathan. Jonathan is the Chief of Physics at the Norton Cancer Center in Louisville, Kentucky. Thank you very much.

Jonathan: Thank you, Tim. I appreciate that introduction and I just want to make everyone aware that the Norton's Cancer Institute's a community-based radiation quality center in Louisville, Kentucky and I wanted to share our experience with Novalis certification and hopefully provide the listeners with the tools to proceed with the application in the Novalis certification. So as you mentioned, I work with Brainlab in the Novalis certification process as an auditor also. And in this presentation, I'm gonna split it up into four different sections, specifically the beginning to the end of the Novalis certification process. As Dr. Solberg introduced, the reviewer will start with the site on an introductory webinar. And that looks at the pre-audit self-study and really looks through every single element of that with the institution. And the reviewer will help provide some guidance on how to complete that document given the dialogue between the site in terms of what technology that they have in place, what their staffing is, what their training is, and also what their quality management process is and their structure. During that webinar, there's also the opportunity to look at some of the sample documents that Dr. Solberg has presented here already. And also to look at the institution's documents if they have something that they want to present at that time.

So moving on to the pre-audit self-study document. So with this, it encompasses a large part of your program in terms of structure, in terms of what disease sites we manage, the number of patients for each disease site. And that really sets the foundation for the application. So beyond that, we need to submit some supporting documents to demonstrate that the institution is meeting the Novalis standard. So the documents will be pretty comprehensive and quite lengthy. So I'm gonna describe in a little bit more detail the supporting documents that we submitted as part of our application. And how we've decided to do this is really to look at the Novalis standard itself and to segment out the different components of the standard. So the program structure and goals, personnel requirements, technology requirements, quality assurance requirements.

So looking at the program structure, so we're looking at the administrative clinical and technical infrastructure that you have in place as well as your clinical protocols. And this is an example that we have for one of our clinical protocols for AVM that looks at the unique features of the imaging for that process, as well as the clinical checklist to guide through the imaging process. And also the prescription, organ at risk constraints, and the technology. Not necessarily just a list of the technology but also how that technology is implemented. Different institutions may have different applications, the same technology. So being able to describe that in the pre-audit self-study is helpful for the reviewer.

In terms of personnel requirements, it's important to look at your staffing model. I mean, our institution, we reviewed our physicist/dosimetry staffing last year, and one of my colleagues had a pretty comprehensive review in terms of number of patients, complexity of programs that we manage. So if you're able to describe the staffing that you have in place, make sure that you have sufficient staff in terms of physicists, therapists, and the clinical staff. And over time as well, I think the roles and responsibilities of staff evolve. So I feel it's very important to look at staffing...

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Jonathan: Apologize for the delay. We had some technical difficulties there. But just to review real briefly personnel requirements. It's important to ensure we have sufficient staffing. We completed an analysis of physicist and dosimetry staffing levels as our radiosurgery program has grown to ensure that we have enough staff to support the developments as well as the additional treatment sites which added another layer of complexity.

Training and education. We keep good documentation of vendor-provided training for all staff as well as in-house training. This is an example of an in-house presentation we had from our physics team that shared some of the nuances of the exact track system with our therapists who are the users of the exact track system. The other component of the personnel requirements is to make sure that your staff are qualified. So several of these documents may be contained in personnel file. So if it's not appropriate to send that in advance for the review, a lot of that may be reviewed on site. In terms of technology requirements, or review of your commissioning for each component.

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[00:40:29]

Jonathan: So we're having some connection difficulties there. Apologize for that. We completed comparison of our beam data at the time of commissioning with that of another institution which was essential for the success of our commissioning process. And also acceptance testing on radiosurgery hardware and software. This is an example of one of my colleague's work on acceptance testing for a localizer box. We participate in research studies, and as part of that, we're able to irradiate and having evaluated a phantom from MD Anderson, this is results for radiosurgery phantom and spine phantom. If you have a similar mechanism at your institution or in your country, this is a very powerful end-to-end test. And of course, in terms of quality assurance, if your quality assurance program is well-documented, the whole framework for that should be submitted in your documentation as well.

[00:41:34]

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[00:42:39]

Jonathan: So we're looking at the on-site review process. This was an example of our schedule for our Novalis audit. It looks at the different components and requirements of the Novalis standard at different time intervals. And this really gave us the opportunity to pull different members of our team into the different meetings at the relevant time points. We can adjust this as needed in terms of the amount of time to look at each aspect of the program, but should also incorporate the opportunity to look at the implementation of your program in terms of CT simulation, in terms of treatment planning, treatment delivery. So we started our day looking at the multidisciplinary clinic tumor board at the Norton Cancer Institute. And that really gave our reviewer the opportunity to look at all the different professionals that were involved in the decision-making process for radiosurgery for patients looking at the structure. And also, the care path, the process, in terms of bringing the patient into the clinic and managing the patient's care as well as the multidisciplinary nature of the radiosurgery decision-making. And also at this meeting, we have the opportunity to look at the potential to enroll patients in research studies. So this gave us a great start to our days. Not necessary, but our institution gave a reviewer a good introduction to our program and the process.

The on-site visit, we had SRS simulation. So our reviewer is able to see the process for mask manufacturing, to look at the CT protocols, make sure that they were in keeping with the standard and also discuss the experience with the staff and their training in terms of the SRS work that they're engaged with. And also look at the workflow and the checklists and safety barriers that we have in place at each stage of the radiosurgery process for patients. We looked at the radiosurgery treatment on the same day. This was a review of the patient's setup, walking through the checklist for pre-treatment that was performed by therapists, as well as the imaging. At which time points our physicians and physicists engaged with the treatment delivery? And we also had the chance to look at the treatment plan for this patient as our treatment planning system, we were able to view that over a network environment.

This is just one example of our checklist. This is a checklist that's developed in a record and verify system which is Aria. So this is our encounter in their terminology for trigeminal neuralgia. So this says specific and unique verifications require pre-treatment. In terms of the documentation review on site, we laid out and shared our documentation according to the different elements and components of the study of the evaluation rather. Other things to consider is your institution should have a well-developed incident reporting system. One of the feedback that we received as part of Novalis certification was that although our system work well, there was an opportunity to add near misses to the incident reporting rather than just actual events like which patients. So we've since expanded that and greatly improved our quality and safety for radiosurgery. You have to have a clear mechanism and process in place for documenting safety notifications from vendors. So this is just a description of our process, as well as equipment maintenance and verification. And also the utilization of your equipment. This is just a flowchart to document our simulation process. We had two different accelerators, and at the time of simulation, we needed to determine which accelerator we were gonna schedule the patient. So there's some complexities in that because the machines were not operating on the same software version. So just any description of how your system is implemented.

Then at the end of the day, we complete an exit interview. And that, again, includes all the stakeholders in your radiosurgery program: administrators, positions, therapists, physicists. The reviewer will describe the findings from the offsite review as well as the on-site review to give the clinical indication of the level of success with the application process. And then once the process is successfully complete, you receive a certificate of compliance, which includes action items for quality improvement. And we've really taken those action items instead of quality improvement groups in order to address those items. I think also the Novalis standard is a very powerful tool to just demonstrate the implementation of your radiosurgery and SBRT program.

So I'll just conclude by making some suggestions to ensure success. I would encourage anyone who's undergoing this process is to start early. You may discover when you look at the standard and you look at some of the processes involved, that you may need to change the structure within your department in terms of quality committee meetings. And that will really help focus on driving some of the other components of the Novalis standard. At our institution, we had great buy-in from our clinicians, from our therapists, from our physics team, and dosimetrists as well. So getting everyone on board and actually distributing some of that workload between the entire team really helped us complete the application, complete the paperwork, and update our procedures. And as Dr. Solberg mentioned as well, the reviewer is also a great resource as part of this application process to ensure that your study documents and your policies and procedures are in place and are in keeping with the standard.

So at this point, we'll move towards questions and answers. And I do apologize for some of the technical difficulties we had during my presentation. Hopefully we can address some of those now.

Dr. Solberg: This is Tim. Can everybody hear me okay? We do have a couple of questions. I think I may still be muted.

Jonathan: I can hear you, Tim.

Dr. Solberg: Okay. So I have a question. There's a question that came in for Jonathan. Why did you decide to proceed with certification and how pleased were you with the process and what's the results?

Jonathan: We decided to proceed with it because we wanted a lot more thorough review of our procedures. And at our institution, we knew that our radiation oncologist had plans to expand the program to more complex disease sites. When we went through the review process, we were either just beginning or just considering expanding a program to functional disease. So we really wanted the assurance that our systems were well-commissioned, that our quality management program was rigorous, and in order enough to proceed with the expanding of the program and the development of the program.

Dr. Solberg: And how do you feel the process went and how pleased were you with the results?

Jonathan: I think the process went very well, and what it's really given us in terms of results and moving forward is it's given us a framework to move on as we develop new treatment sites, as we commission new technology. You will also often look back at the standard and some of the documentation of the standard and the principles of the standard and we'll keep that in mind as we proceed with our practice of radiation oncology and medical physics. So we were happy with the results. And as I mentioned in the presentation, some of the outcomes and the recommendations, we put it as quality improvement projects and really helped us move our program forward.

Dr. Solberg: That's great. Thanks, Jonathan. There's another question that's come in. I'll maybe take this one. What's the overlap with the ACR and the ASTRO accreditation programs? That's a really good question. You know, in theory, there's really no overlap. They're separate. And this could apply to other certification programs and in other areas and countries too. They are separate. Neither ACR nor Astro specifically look at the stereotactic programs. So the Novalis Certified is specifically for stereotactic programs, and it is the only stereotactic accreditation program. That said, if a center is ACR or ASTRO accredited or is going through that process, there's certainly a lot of kind of general preparation and documentation that applies well to the new Novalis Certified program. So, you know, all of the kind of things that are standard with regard to personnel issues, training, staffing, credentialing, all of the things that are related to policies and procedures, these are all things that ACR and ASTRO will also evaluate. And so there can be a lot of synergy if a center is already ACR or ASTRO accredited. They're gonna have already 90% plus of the information in place for the Novalis Certified program. And similarly, if they're going through the ACR or ASTRO process, these things can function very nice in parallel. You can really do both of the programs in parallel. So I hope that addresses that.

Jonathan: There's an additional question here. Are any of the accreditation programs, including Novalis Certified, review themselves?

Dr. Solberg: Okay. Sorry, Jonathan, can you repeat that question?

Jonathan: Yeah. So the question is, are any of the accreditation programs, including Novalis Certified, review themselves? I think what they're asking is, is there a review mechanism for the accreditation programs itself?

Dr. Solberg: Yeah, that's a very good question. So there's an ongoing process of the Novalis Certified program with the experts. And occasionally, some experts leave the program and others join. But there's kind of a continual review of the Novalis Certified program through that expert process. As I mentioned, the Novalis standard is being reviewed and updated. It was originally written, I think, in 2011 or '12. And certainly, there's been a lot of developments in the field since that time. But there's not another formal body that accredits or certifies the Novalis Certified program.

Ethan: All right. Well, it looks like there aren't any more questions. So thank you so much, Dr. Solberg and Jonathan, for your time and effort with these presentations. And if anybody else has any questions about Novalis Certified, you can always reach out to either one of these folks or your Brainlab representatives for more information. A couple last-minute things here. As far as this webinar, you can find the recording at novaliscircle.org. And also, it's been CAMPEP, MDCB, and ASRT accredited. So you're gonna get a follow-up email, follow-up survey following the webinar that you can go ahead and request those credits. As for the next webinar, we have a technical webinar presented by Brainlab coming up November 2nd from 12:00 to 1:00 p.m. Central Time. This is going to go over the multiple brain mets SRS element and we're gonna go through some complex clinical scenarios and, you know, how to address those as far as the planning algorithm and planning element go. Thank you all so much for your time and we look forward to having you join us at our next webinars.