ML23283A285
| ML23283A285 | |
| Person / Time | |
|---|---|
| Issue date: | 09/12/2023 |
| From: | Office of Nuclear Material Safety and Safeguards |
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| ML23283A056 | List: |
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| Download: ML23283A285 (27) | |
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U.S. NUCLEAR REGULATORY COMMISSION Transcript September 12, 2023, Public Meeng on Terminaon of U.S. Nuclear Regulatory Commission Recognion of the American Board of Radiologys Cer"caon Processes This transcript was produced using the Microso Teams soware. Edits were made to remove me stamps and repeang speaker names, to correct misspellings and incorrect words, and remove repeang words.
0:0:0.0 Sarah Lopas (She/Her)
Alright, so good aernoon everybody and thank you for joining us for today's and RC public meeng on the terminaon of the US NRC recognion of the American Board of Radiology cer"caon processes.
My name is Sarah Lopez, and I'm going to be your facilitator for today's meeng.
During this meeng, the sta will be discussing the American Board of Radiology or ABRs decision to eliminate its NRC recognized cer"caon processes and disconnue or stop issuing the ABR cer"cates.
The authorized individual designaons aer December 31st, 2023. So I'm going to put a link in the chat with the ABR leter. Or perhaps I already did. I have to double check either way. I'll put that link in there, but the leter that AVR sent the undersea and leng us know that that was their plan. I'll get that in the chat. And if you don't have access to the chat, you're on the phone. We have an Adams accession number for that leter. It's ML22091A272.
So the NRC sta is also going to be discussing how aected individuals can apply for authorized individual status today. In just a moment, Ms. Maryann Ayoade, who's a health physicist in the NRCs Oce of Nuclear Material Safety and Safeguards and a member of the NRC's medical radiaon safety team. She will be giving today's presentaon and the slides that Maryann will be presenng are publicly available also.
And I'll put a link to those slides in the chat as well. But if you again, if you don't have access to the chat, the accession number for those slides is ML23254A377 and you can also "nd the link to the slides in the public meeng noce for today's meeng.
So today's meeng is being transcribed, and we're also recording it so we have a backup to the transcript. There will be me for quesons aer Maryann is done with her presentaon, so when we get to that point in me, I'm going to be, I'm asking you to use the raised hand funcon if you're using Teams and I'll call on you. That way, if you've called in, if you're on your cell phone, you've called in using the teams bridgeline, you'll just press Star 5, and that's how I'll know that you want to make a comment.
That's how you raise your phone or raise your hand via the phone. Pressing Star 5 and you press star 6 to unmute yourself, but I'll go through that again when we get to that point. If you are calling on from the phone and you want your atendance recorded for today, so for the meeng summary that will go out eventually. And please email Maryann Ayoade and I will put her email in the chat as well.
And then also if you have addional quesons following up from today, you can either email Maryann or that we have a medical quesons resource email that the NRC's medical team keeps an eye on and responds to frequently. So you can send quesons either way. As I noted, we also have the chat open, so 1
I'll look for stu that I'll be posng in there. And as I said, please use that to communicate any quesons or comments to us. Once I stop talking, I'll be watching that. And if you're having technical issues, I'll try to help you out via chat.
OK. And so with that, I am going to turn the meeng over to Ms. Celimar Valenn Rodriguez. She's going to be giving her opening remarks. Celimar is the team leader for the NRCs medical radiaon safety team in the Division of Material Safety, Security, State and Tribal Programs. Celimar.
0:3:31.950 Celimar Valenn-Rodriguez (She/Her/Hers)
Thank you. Sarah, can you hear me? OK. Good aernoon, everyone, and thank you for atending this public meeng today on the ABR's decision to disconnue their recognion of medical specialty board processes. As Sarah introduced me, I am the medical team leader here at the NRC. We recognize there's a lot of interest around this topic, so we really appreciate you taking the me to atend this meeng today, and before we begin the meeng, I'd really like to acknowledge and thank Ms. Maryann Ayoade, who's taking the lead on this issue on behalf of the NRC's medical team, and Sarah Lopas and Chrisne Pineda for their facilitaon and project management for today's meeng.
So by way of background, the Commission, I just wanted to give you a brief background of where we are in terms of our training experience eorts within the NRC's medical team. You all might remember our training and experience requirements for unsealed byproduct material rulemaking plan, which was issued to the Commission back in 2020. We received a vote on that paper in January 27 of last year, 2022, and the Commission at that me voted to maintain our current training and experience requirements for the use of unsealed byproduct material in part 35.
However, as part of that Sta Requirements Memorandum, we received addional acons. One of them was to reevaluate or reconsider training and experience requirements for emerging medical technologies. This is being done as part of the emerging medical technologies, Rubidium-82 generator rulemaking. If you atended our public meeng a few weeks ago on the regulatory basis, you might have seen a lot of quesons regarding T&E for emerging medical technologies. We were also directed to complete an evaluaon of all medical specialty boards. So this was completed in July of last year and as a result of that evaluaon of the eleven boards that we recognize at the me, two boards, CBNE and AOBNM were found to be inacve.
And "nally, the Commissioner also directed us to develop implementaon guidance for training experience requirements. That is an ongoing eort which we plan to issue that guidance in the summer of next year. So as Maryann, we'll cover today in April 6th of last year, ABR informed us of their intent to disconnue their and NRC recognion of all their medical specialty board processes by December 31st of this year. So during today's meeng, Ms. Ayoade will provide an overview of the dierent pathways that we have at the NRC for becoming an authorized individual, including the alternate pathway, and what ABR's terminaon means for those physicians, radiaon safety ocers and medical physicists who will seek authorized individual status in the future. And she will also cover what our next steps will be regarding ABR's terminaon.
So as a reminder, in an eort to maintain the focus of this meeng on the ABR disconnuaon or terminaon, if you have any speci"c quesons about T&E requirements, about how to become an authorized individual or what requirements apply to your speci"c situaon or background, please 2
contact your regulatory authority or contact us. Sarah gave our medical quesons resource, which again is medicalquesons.resource@nrc.gov.
And with that, I will turn out the meeng to Ms. Ayoade.
0:6:57.40 Maryann Ayoade Thank you, Ms. Valenn, can you all, Sarah, can you hear me?
0:7:2.840 Sarah Lopas (She/Her)
Yes, Maryann, loud and clear.
0:7:3.960 Maryann Ayoade OK, good.
Good aernoon, everyone and again, welcome to today's NRC public meeng. Today's presentaon is focused on determinaon or disconnuaon of the NRC's recognion of the American Board of Radiology cer"caon processes as Ms. Lopas and Ms. Valenn menoned, I am a member of the NRC's Medical radiaon safety team and again I want to menon, as you heard from Ms. Valenn, that we will be taking quesons during this meeng about the informaon that's presented today. But this is not the forum for quesons related to speci"c licensing acons, because trying to respond to those speci"c types of quesons will take up a lot of me and go beyond the me that we have alloted for today.
And so for any quesons that you may have related to speci"c licensing acons or your parcular situaon, as I have already been receiving some emailed quesons, please do reach out to us or go to your regulators in your state if you're an agreement state or our licensing sta in our NRC regional oces that are within your jurisdicon.
Uh, so let's go ahead and get started. Uh, next slide please, Sarah.
OK, so for the presentaon today, I will be providing background informaon on how to become an authorized individual on a radioacve materials medical use license. And I'll go over the main training and experience pathways that quali"ed individuals may use to demonstrate that they meet the training requirements in 10 CFR part 35. I will also go over some of the background on the ABR's recognion from when they were "rst recognized to where they are today, with the pending terminaon or disconnuaon of your NRC recognion. And then I will be discussing the when, the what, and the why surrounding their intent as they have informed us that NRC.
Ill also go over what this all means for the current and future potenal authorized individuals and then also talk to you about where you can "nd informaon on how to become an authorized individual, as well as all informaon that's related to NRCs recognized specialty boards and also NRC's procedures for recognizing, monitoring and terminang or disconnuing the recognized boards.
I'll also then get into how to become an authorized individual again, but this me with more focus on the alternate training and experience pathway, which is currently an opon and will remain an opon even aer the ABRs recognion is disconnued. And then I'll go over the current status of the terminaon 3
and the next steps in the process. And then "nally, we'll take quesons that you may have. So I do have a lot to cover for today's presentaon, so let's jump right in. Uh, next slide there.
Alright, so in the next couple of slides, I'm going to provide some general informaon on how to become an authorized individual. And as you may already be aware, this is all about individuals successfully compleng the required training and experience and providing documentaon of their training to the NRC or agreement states to be reviewed and approved in order for them to become authorized and listed on a license.
And so to be authorized and listed on a license means that you're able to independently ful"ll the radiaon safety related dues of an authorized individual as you have been assigned on that license.
Next slide. All right.
So the NRC has three main pathways for individuals that are seeking to become authorized and listed on a radioacve materials medical use license under Part 35.
The "rst is the board cer"caon pathway. So here, an individual's request for authorizaon is primarily based on whether they are board cer"ed by an NRC recognized specialty board and have also received an NRC recognized cer"cate from the board. Now, in some instances, depending on the type of use that's being requested and the individuals training background, and also if they're seeking addional uses beyond what it is that they're cer"ed for, then they may need to also submit addional required documentaon of training that could be in the form of addional hours of classroom and laboratory me, addional supervised casework experience or addional device speci"c training.
The second is the alternate training and experience pathway where the licensee has to submit documentaon of all of the individual training and experience directly to the NRC or to the agreement states for review and approval. And so that is all of the required classroom and lab training hours, the supervised work experience and also any necessary device speci"c training. Again, depending on what they are seeking to be authorized for now, this is mostly similar to the type of documentaon that is submited to the boards when individuals are seeking to be board cer"ed, but a major dierence from the board cer"caon pathway is that in addion to the training documents, they also have to submit a signed atestaon, a signed writen atestaon from a preceptor individual that also meets the requirements for the type of use that's being requested.
OK. And then we have a third pathway for approval and that pathway is based on con"rmaon that an individual is already iden"ed on an NRC agreement state license for a similar or equivalent types of use.
And again, depending on the type of request and the type of authorizaon that that individual is already listed for, they may need to provide addional required training documentaon as I described earlier.
And so when a licensee, you know, comes to the NRC agreement States and they submit a request for an individual to be added onto a license, the licensing sta or the license reviewer is asking the quesons that you are seeing on this slide.
And so we are asking, is the individual board cer"ed and is that cer"cate that was submited, is that one that is currently recognized by NRC depending on the type of use that's being requested? Is the cer"cate enough or does the individual need to provide addional documentaon of their training? If the individual is not board cer"ed, have they submited all of the required documentaon of training and supervised work experience and also have they provided a signed, writen atestaon from a preceptor that also meets the requirements? Is the individual already listed on a license for similar types 4
of uses? Have they provided supporng documentaon of any addional training? If they're seeking to be authorized for uses beyond what it is that they're currently authorized for, uh, how? How recent is the training that they received? When did they receive their cer"caon and is the cer"cate sll valid for use or do they need to provide documentaon of connuing educaon? So those are the three main pathways that I just described.
And for today's presentaon, we will be more focused on the board cer"caon pathway and the alternate pathways because ABR's disconnuaon will aect more of the individuals that are not already listed or authorized on the license.
OK, next slide. OK, so this slide includes a table to further highlight the major dierences between the two pathways that we are focused on today. The "rst is that under the board cer"caon and alternate pathways to under both pathways, all individuals must complete the required training and experience that are listed in the regulaons for the type of use and the type of authorizaon that they're seeking.
So what does this mean for every type of use? Both pathways will require somewhat of a similar type of training and supervised work experience, and so, for example, a physician that's seeking to become an authorized user may see that the board cer"caon pathway may require compleon of training and experience through a residency training program, whether it's in radiaon therapy or nuclear medicine or radiaon oncology, or in a related medical specialty.
It depends on the speci"c type of use that that individual is seeking to be authorized for, and so also in some cases the regulaons may call for addional training in the form of supervised casework for some radio, pharmaceucal therapies or some addional device speci"c training, or radiaon safety related training to be completed even outside of the residency training program. Again, this depends on the type of use that is being requested, so those are some of the types of addional training documentaon that individuals would need to submit to the regulators in addion to the board cer"cates. Again, on a case by case basis.
OK. And so in essence, if an individual's training and experience is acquired through any of the required training routes or programs, like residency training program or college or a university degree or a clinical related type of facility that required training and experience from the hours of classroom and lab and the hours or years of supervised work, work experience and the number of clinical case work that is required by the regulaons, they will all essenally be similar for both the board cer"caon and the alternate pathways for that speci"c type of use.
The second thing to note and to point out on this slide is that is the examinaon requirement that we have for the board cer"caon pathway versus the writen preceptor atestaon requirement is for the alternate pathway. So, NRC requires that recognized specialty boards also administer an exam that assesses the knowledge and competency and areas that include radiaon safety, and you'll see this spelled out in the regulaons and the regulatory language that's under the board cer"caon pathway and also under the alternate pathway as well.
And so, depending on the type of use for the board cer"caon pathway, you will see the requirements here menon that the exam must test or assess the knowledge and competence in radiaon safety and radionuclide handling, quality assurance, treatment planning and certain types of clinical use. Again, all depending on the type of use that you're seeking authorizaon for, and then on the other side for individuals that are coming in under the alternate pathways.
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So those individuals that do not have recognized cer"cates or that are not board cer"ed, the preceptor atestaon is what essenally serves the purpose that the examinaon is serving for the other pathway, and so that atestaon statement is essenally con"rming that an individual has successfully or sasfactorily completed all of the required training, and it also speaks to the individual's ability to independently ful"ll the radiaon safety related work or dues for the type of use that they're seeking authorizaon on.
So again, just to note that in addion to successfully compleng all of the training and experience that is required, the examinaon and the preceptor atestaon are in essence what the NRC has determined to be the elements that show that an individual has the requisite knowledge, and so going through a structured board program that meets the required training and experience and also successfully passing the examinaon for the board pathway and then the signed atestaon statement for the alternate pathway, that is what serves as con"rmaon to the regulators that the individual has the requisite knowledge to serve as an authorized individual, that can not only go on to carry out the uses that they were approved for, but also they can serve as a supervising authorized individual for others as well. And this is why the training and experience and the regulaons surrounding them are very important to know and to understand. Next slide.
OK, so this slide and the next slide aer provides some background about when the ABR was recognized and the meline of the decision to disconnue their NRC recognion. So the ABR "rst became an NRC recognized specialty board in 2005 and this was when NRC had published a rule that amongst other things, updated the criteria that all specialty boards must meet in order to be recognized by the NRC or agreement states. So what this meant was that once a specialty board cer"caon process for a specialty area, once it became recognized by NRC or an agreement state, any individual with a recognized cer"cate from that board may move on to be approved to be an authorized individual.
And I say maybe because there's sll that next step to authorizaon of subming your request to the regulator for their review and approval before you can be added onto a license. And so the request for authorizaon must be approved through our regulatory licensing process. Next slide.
OK, so now fast forward to today and jumping into the when of the disconnuaon and when it goes into eect. So ABR no"ed NRC in March of 2022 and they also submited a formal leter the following month, in April of last year as well. And they submited the leter nofying us of their intent to stop maintaining NRC's recognion of their cer"caon processes aer December 31st of this year. So December 31st of 2023, which is in about 3 months from today, the link to the ABR leter has been included as Sarah or Ms. Lopas menoned earlier, she has included that in the chat, but it's also included on this slide and it's included in our medical toolkit web page under the announcement secon. Uh, the links to the dierent sites are hyperlinked in the slides and again you can "nd them on our website.
And so their leter explained that they intend to stop maintaining the part of their cer"caon process that allowed for them to be recognized by NRC, which means that they will no longer issue their cer"cates with the authorized individual eligible designaon stamps for the dierent authorized individuals. So the authorized user, the authorized medical physicists and the radiaon safety ocers aer December 31st of this year. Next slide.
OK, So what exactly is being terminated or disconnued? What is going to be disconnued is the recognion of ABR cer"caon process for certain specialty areas. Speci"cally, they intend to no longer maintain the part of their examinaon that tests the knowledge and competence in radiaon safety in 6
accordance with the requirements in part 35, and, as I menoned earlier, the board cer"caon pathway does require that their candidates complete and pass an exam that tests and assesses their knowledge and competence in radiaon safety as part of the requirements for NRC's recognion. And so you will see on this slide and in the table here that all six of the current NRC recognized ABR specialty areas are impacted. And so the authorized user eligible designaon that you will see on some of the ABR cer"cates that is for physician candidates and supports recognion of ABRs cer"caon process for three specialty areas in diagnosc radiology and intervenonal radiology and diagnosc radiology. The Joint IR/DR program and also in radiaon oncology. And then for the radiaon safety ocers, the RSO eligible designaon that you will see on the ABR cer"cates supports recognion of the ABR cer"caon processes for two specialty areas that you see in this table in diagnosc medical physics and in nuclear medical physics. And then, for the medical physicist candidates, the AMP eligible designaon that you see on the ABR cer"cate is what supports the recognion of the ABR cer"caon processes for the therapeuc medical Physics specialty area. Next slide.
Hey. So I think go back one more slide, please. Yes. Did you? I'm not sure if we were on this slide. I think you skipped this one, so the why of the terminaon?
Why is the terminaon or disconnuaon happening, and are there any reasons behind this? OK. So the ABR has explained to us that NRC that maintaining their recognion falls outside the de"ned focus of the board's mission, that it diverts the resources from their fundamental objecves, some of which include re"ning their examinaon processes and providing the ecient customer service that they do to their candidates. And also they noted that there's no speci"c correlaon or required link between being board cer"ed and having an authorized individual eligible status because individuals could be authorized in a license without being board cer"ed and individuals may also be board cer"ed without ever becoming authorized individuals. And then lastly, they noted that a direct pathway exists with the NRC and agreement states for verifying an individual's require training for authorizaon.
And so, at the botom of this slide, you will "nd links to addional informaon that the ABR has provided on their decision. The "rst two links on this slide at the botom are for an informaonal webinar that ABR hosted in March of last year. So, in March of 2022 and they provided the webinar to assist the aected individuals with how to navigate through this transion. And then the last link is to another ABR web page with quesons and answers that they've provided. Related to this issue and to their decision as well, next slide.
So, what does all of this mean for individuals and in our NRC authorizaons? What are the potenal impacts? First of all I want to clarify that prior to that December 31st disconnuaon date, so between now and the end of the year, because ABR will connue to comply with NRC's regulaons, and unl this date ABR is sll able to issue NRC recognized cer"cates with the authorized individual eligible designaons. And so this means that these cer"cates will remain valid and can be used to seek authorizaon through the board cer"caon pathway. The ABR website has informaon on when their candidates can sit for their exams to be able to receive a recognized cer"cate before this December 31st date. And it is my understanding that as of today, the last administraon of the exam will be on December 5th according to whats posted on their website, and the applicaon window for this exam has already passed.
So you can go on to the ABR website to "nd out informaon on all of this, but also keep in mind that the recognized cer"cates will again remain valid for seven years from when they were obtained or issued, 7
and this seven year requirement is in accordance with the regulaons for recentness of training or what some may see as connuing educaon, which is in 10 CFR 35.59.
And then we also have the board cer"caon pathway opon for individuals that wish to obtain cer"caon from a dierent NRC recognized Specialty board, which you can "nd listed on our on our NRC recognized specialty board web page. And we also have the alternate training and experience pathway, which I will be going over some more in coming slides, next slide.
And what is going to happen aer December 31st? So aer December 31st, ABR will not maintain the NRC, their NRC recognion. And so in other words, the cer"caon processes will no longer be seen or recognized as being in compliance with the applicable NRC regulaons. And also there the ABR cer"cates will no longer be issued with the authorized individual eligible designaons and cannot be used for authorizaon for medical use through the board cer"caon pathway. And so the last four bullets are similar to what was presented in the last slide.
As I menoned, individuals with valid or recognized cer"cates that were issued prior to December 31st can sll use these cer"cates to request authorizaon through the board cer"caon pathway. The seven year recentness of training requirement will connue to apply, and then the opon for individuals to use a dierent NRC recognized specialty board is sll available and the alternate training and experience pathway sll stands. Next slide.
OK, so where can you "nd informaon on how to become authorized and the NRC's recognized specialty boards? The slide includes hyperlinks with all of the relevant informaon for individuals that may be seeking NRC authorizaon on a medical use license through the board cer"caon pathway and beyond.
The "rst thing I want to point out on this slide is that we do have a public NRC web page for just about everything related to medical uses for our licensees and the general public. And that is our NRC medical uses licensee toolkit Web page. On this web page is where you will "nd a secon on the recent announcements that we make on several ongoing medical related projects including this ABR terminaon or disconnuaon. And then you will also "nd the link to our dedicated NRC recognized specialty board web page and that includes informaon on the boards, the dierent specialty areas and cer"cates that we recognize and also those that we no longer recognize. And this page also includes informaon on how to become an authorized individual. You will "nd there a link to our NRC procedures for recognizing, monitoring and disconnuing of the cer"caon processes of specialty boards and also our most recent evaluaon that NRC conducted in 2022 of all of the recognized boards and their status.
We've also included on this slide some other useful links that are on the medical uses licensee toolkit web page, like the NRC's Advisory Commitee on the Medical Uses of Isotopes, the ACMUI, they have a dedicated web page, and also you will "nd informaon about their Training and Experience Subcommitee report on the ABR's decision. And so that report includes their thoughts, their recommendaons, and their feedback on the impact of this issue at hand.
Also included is a link to the NRC's medical related Q&A, or frequently asked quesons, and the NRC's medical list server. If you aren't a part of that already, you can sign up to receive or automated email no"caons of medical related informaon and even medical related Federal Register noces. Next slide.
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OK, so now this slide has been added as a reminder because in the next couple of slides and as I menoned earlier, I will go over the alternate pathway opon in a litle bit more detail and that opon can be used to get authorizaon and be to be listed on a license if you're not cer"ed by a board that the NRC recognizes, or if you do not have a recognized cer"cate from a board.
So since today's presentaon is focused on ABR, I will use that in my explanaon as an example. So if you're an individual or a physician or a physicist that has been considering and is working your way towards geng an ABR cer"caon next year, what do you need to do? Well, "rst of all, you should hopefully already be aliated with a licensee from an NRC agreement state, because the process to request authorizaon starts there. The request for authorizaon for an individual to use radioacve material must come from the licensee or an applicant or enty that is seeking to use radioacve material. And so you'll noce the note that I've included at the botom of this slide that says that NRC does not issue licenses to individuals, but rather to licensees and NRC authorizes individuals to be listed on a license.
And so we do get quesons somemes related to this issue. So we have included that on this slide for further clari"caon. OK, so the licensee submits the request to add someone to their license and they have to include all the applicable training and experience documentaon for the individual, and they also have the opon of using our NRC forms, which is a version of the NRC 313 applicaon form that is inially used to apply for a license. But these forms are the NRC 313A series of forms for dierent types of authorized individuals, and the dierent types of uses that can be requested. And I've included a link to those forms, along with the accompanying instrucons and guidance, which is our NUREG-1556 volume 9. I've included that along with the speci"c secons in that document to help complete these forms, and so you can also "nd all of these links in the presentaon for today. Again, just by Googling our NRC medical uses licensee toolkit web page and you can "nd all of these links in there as well.
I also wanted to point out that it's important to know your agreement state program if you are in a state that is not under NRC's jurisdicon, you will need to check with your state's program because some states may have their own forms that you can use to provide this informaon as well. Next slide.
OK. So on this slide and the next couple of slides, you will see about 5 to 6 pages of one of the types of 313A forms that I menoned that can be used to submit documentaon of an individuals training as well as a secon for the preceptor individual to complete and sign. And so I won't be going over the forms in detail today for the sake of me, as there's so many dierent opons to complete depending on the type of the request and the individual's training and work experience.
But I will walk you through the types of opons to expect when you use these forms, and so for today I will be using a sample blank form for a physician that wishes to use material under 10 CFR 35.400 and 600, which is for manual brachytherapy uses and for ophthalmic or eye related use of stronum-90 and also for use of remote aerloader teletherapy and gamma stereotacc radiosurgery types of units.
So on the "rst page is where you will complete informaon about the proposed authorized individual.
Now in this case it will be for the proposed physician authorized user because of the form that we're using. And so you will include informaon about the individual and where they're currently licensed.
You will also include informaon about the type of use that's being requested, so you'll noce the "ve boxes of opons at the top of the form that you can check, and then you can get and then you go into part one, part one of the form, which is where you start to indicate whether youre board cer"ed by an NRC recognized board or if you're already an authorized user in a license and are seeking addional 9
authorizaon for uses that you checked earlier. Or if you don't fall under these two "rst two categories, then the third item takes you to where you can provide informaon for the alternate pathway, starng with details of your classroom and laboratory training the locaon.
So where did you receive your training? The number of hours of the training and then when the me frame, the dates that you received, the training, you put all that informaon into this secon of the form, and you'll noce the box at the end are at the botom for the total number of required hours of training to be added there as well. Next slide.
OK, so the next three slides are including this slide gives you tables where you can provide details of the required supervised training and work experience for the dierent types of uses that are being requested. Again, you'll see the secon to include the total number of hours of work experience, and also at the botom a secon for the supervising individual to provide your signature and evidence of their current stance as an authorized individual, which will be in the form of a license number that they are already listed on. And just like the previous slide, you will also need to complete informaon about where and when you received the training. Next slide.
OK, so this slide shows the page that you would complete again the supervised training and work experience for the other types of uses that this form allows. So for the ophthalmic treatments at the top and then later on for the remote aerloader teletherapy and gamma knife type of uses, you will include the training and work experience in this secon of the form. Next slide.
And then that connues here again with the supervised work and clinical experience for the dierent types of uses. Next slide.
So back one, there you go, and then you get to where the preceptor informaon can be provided that would be on the last two pages of the form. And so on this slide and the next slide that you will see, this is where the preceptor individual is atesng to or in essence they're vouching for the training and work experience that has been provided to that individual. And as the form itself says, here they are atesng that the proposed authorized individual has sasfactorily completed the required hours of classroom and laboratory training, as well as the required hours of supervised work and any required years of supervised clinical experience that the regulaons call for.
And so they are atesng that the individual is able to independently ful"ll the radiaon safety related dues as an authorized individual. In this case, an authorized user for the speci"c types of uses that are being requested. So that's what you will see in this secon of the form. Next slide.
And here the preceptor atestaon connues into the last page of the form. I want to point out that this page also includes where informaon about the preceptor can be provided. So if they are authorized individuals, in this case an authorized user, or if they meet the requirements to act as a preceptor using the residency program director route, the catch here is that there has to be at least one residency program faculty member that is an authorized user for similar types of uses being requested and that authorized user faculty member does agree or concurs with the atestaon that the residency program director is providing. And so all of that speci"c informaon that requirement for the preceptor that I just menoned, all of that is spelled out in the regulaons for you, for this type, for these types of uses, next slide.
10
OK, so as another "nal reminder and then important takeaway from today's presentaon, this table has been included with informaon that you saw and heard earlier about what to expect between now and the end of the year. And then what happens come January 1st of 2024? And so remember that prior to December 31st, ABR will connue to comply with NRC's regulaons and they will maintain the recognion and individuals have the opon to obtain an NRC recognized cer"cate from the ABR. But aer that date, any cer"cates that are issued will not include the authorized individual designaons, as the ABR will no longer have criteria that fully meet NRC's requirements, and also just to take note of the other criteria that I spoke to already, and they apply now and they will connue to apply even aer this date. And that is the criteria that you see here in the blue secon of the table related to the recentness of training or connuing educaon and also the alternate pathway that connues to exist. Next slide.
OK, So what is the current status and what are the next steps in this process? And so the disconnuaon or terminaon of their recognion is set to occur on December 31st and we will be issuing a "nal disconnuaon leter to ABR someme in the November, December meframe of this year. We've already been communicang this news informally through our dierent relaonships with the professional sociees and through our agreement state counterparts and now via this public meeng today. So aer that "nal leter is issued to ABR, we will send out a communicaon to the medical community and the public at large using our medical list server and through announcements on our medical uses licensee toolkit web page and also in our communicaons with the medical professional sociees and our agreement state counterparts.
And so we ask that licensees and potenal authorized individuals start now if you haven't already started out to pracce keeping good track of your training documentaon and also complete your NRC 313A series forms early if possible. You want to get familiar with the training and experience regulaons in part 35 and any requirements in your agreement states as well. And of course, we're here to assist you.
Your regulators and NRC and agreement states if you have any quesons, next slide.
That includes the abbreviaons that were in the presentaon for today and the next slide takes us to our queson poron for today. Again, as a reminder, this meeng is not a meeng about speci"c training and experience requirements, but if you do have quesons related to T&E or queson about your parcular situaon or licensing acon, I ask that you reach out to your regulators, reach out to us separately for your speci"c situaon. But yes, Sarah, we're ready for quesons.
0:46:6.290 Sarah Lopas (She/Her)
OK, So what I'm going to do everybody is I'm going to enable everybody's microphones, but if you don't touch anything, you will stay muted cause you control your own mute buton. I cannot unmute you, but I'm going to allow everybody's microphones. And so this will allow you to unmute yourself.
So I'm going to ask, we do have a number of quesons that came in via the chat. So we'll start with those, but go ahead and just hit that raise hand icon, which should be maybe somewhere towards the top right hand of your Teams screen. So you just hit that and I'll use that to call on folks.
And then if you're on the phone, which I don't think we actually have anybody on the phone, but if you happen to be on the phone and I don't see you, you'll be pressing star 5.
So let me get started with some of the quesons that came in via the chat and then we'll go. I see a couple hands raised.
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0:47:5.470 Maryann Ayoade OK.
0:46:59.220 Sarah Lopas (She/Her)
So Maryann, there was one queson came in that Celimar responded to and I just want to read it out loud and then I can either read Celimars response or you can just reiterate it.
So Mark Winslow asked, Will previously recognized board cer"cates sll be recognized? Hang on a second. I'm "nding his whole. Will previously recognized board cer"cates sll be recognized or all ABR board cer"cates no longer accepted. Or does this change only apply to those that are newly boarded?
0:47:32.760 Maryann Ayoade There.
0:47:32.370 Sarah Lopas (She/Her)
And you want me to read?
0:47:33.80 Maryann Ayoade Did you say? Oh, I wasn't sure if you said you were going to read the response.
0:47:36.70 Sarah Lopas (She/Her)
I can read you have to.
0:47:36.720 Maryann Ayoade I see it and then I can add on to that response.
0:47:38.990 Sarah Lopas (She/Her)
Yeah. So I'll read the response. So Celimar responded that cer"cates with the AU eligible RSO eligible or AMP eligible designaon issued prior to December 31st, 2023 will be accepted. New cer"cates issued by ABR aer December 31st, 2023 will not have those designaons and will not be able to be used.
0:48:1.720 Maryann Ayoade OK. Thanks, Sarah, and I can clarify that some more. Again, as Celimar menoned in there, it's the ABR recognized cer"cates that are issued prior to December 31st.
I say ABR recognized because ABR does issue cer"cates without the authorized individual designaon.
What gets you the designaon is the part of the NRC requirement that asks that the board ful"lled the examinaon poron and the examinaon has to be passed by that individual, right? So the way ABR 12
does it is they have these examinaons and there is a secon of the way they grade examinaon which is called the radiaon isotope safety examinaon or RISE, and that poron is what addresses fully all of the radiaon safety related areas or topics that NRC requires.
If the individual completes the examinaon and passes that poron that is speci"cally what earns them that authorized user eligible designaon because they have fully met NRC's requirements in addion to all of the training and experience documentaon that ABR has reviewed.
So once they put that on their cer"cate and they submit that to the NRC, if it was issued prior to December 31st, you know it's that that cer"cate, it's valid to be used again, anything before that.
We also have to keep in mind the seven year recentness of training or connuing educaon requirements and so if that cer"cate falls within seven years, they can use that cer"cate.
If it's beyond seven years, then they have to provide that addional documentaon of connuing educaon in that me frame.
0:49:51.440 Sarah Lopas (She/Her)
OK. Thanks, Maryann. I'm going to get through a couple more of these chats and then I will go to the two hand raises, I promise.
OK. So the next queson here on the chat is from an unknown user says Will NRC be stang up to support a greater demand for AU requests via the alternate pathway? What is the esmated? And here's the second part of that. What is the esmated meframe from submission to approval, assuming all the paperwork is in order and correct?
0:50:24.130 Maryann Ayoade OK. Thanks Sarah. Oh, that's I mean that's a good queson and that is something that currently NRC we're monitoring you know the terminaon hasn't gone into eect yet.
We do have the alternate pathway which we have goten feedback from our regional sta, our license review sta that they do get a good amount of licensing acons with individuals coming in under the alternate pathway even before, you know, this request from ABR came in.
Again, it's not just NRC. We're also in contact with our agreement state regulators and they have, you know, a lot more licensees. And so we're also going to be in contact with them as we move forward in this next phase with the expectaon to see more acons or requests for individuals coming in under the alternate pathway.
And then as far as the meframe, again with the alternate pathway, it's dependent on the speci"c, the type of requests dependent on the type of individuals of training that they already have, because we have to review again, if they're, if they don't have a cer"cate, but they had a cer"cate that was recognized, but yet before the seven years, we have to take a look at the type of connuing educaon that they have. So there's a varying amount of meframe.
13
Our advisory commitee, the ACMUI, did talk about this as a potenal challenge as we move forward and they did give us, you know, some feedback on, you know, there isn't any like set meframe to review our licensing acons through the alternate pathway. But this is something that we're going to be monitoring as we move forward.
Celimar I don't know if you wanted to add anything to this one.
0:52:19.880 Celimar Valenn-Rodriguez (She/Her/Hers)
Yeah, I mean with respect to the esmated meframe at, in the NRC, we have diering melines for dierent types of licensing acons that can range from 90 days up to 180 days. And if you have renewals that might take longer, also it will also depend on the quality of the applicaon. If you have most or all of that documentaon that the license reviewer will need, then you'll probably have a more speedy approval of that authorized individual. So that's very important and I will also note that agreement states have dierent milestones and meframes for their own licensing acons. So that will also vary state to state.
0:52:59.620 Sarah Lopas (She/Her)
Yeah. And I'm going to follow up with one of the quesons from the chat related to that.
So this is Margo. Shoot, she's, she asks when should the forms be submited with residents graduang June 30th? How much in advance or how far in advance for residents graduated June 30th.
0:53:19.470 Maryann Ayoade I mean to that I would say it depends on when they want to start using the license. Like Celimar said, depends on the type of license. See if it's a new license applicaon or a new license, we have a dierent meframe for that. If it's for amendments where youre amending a current license to add the individual, we have a dierent meframe that depends on the agreement state that you're in. So I would say, you know, reach out to your, to us, your regulators or your agreement states that you're in depending on when you're looking to have that individual, you know, start. That's, I think what you should go with as far as meframe for subming, but I would say start keeping track of your training and experience as you move forward and you can use that form to document it, yeah.
0:54:9.850 Sarah Lopas (She/Her)
All right. One more and then I'll go to the two hand raises and then I'll connue with the chat quesons.
0:54:15.740 Maryann Ayoade OK.
0:54:15.550 Sarah Lopas (She/Her)
So Todd and I'm going to mispronounce your name. Todd. Todd Senglaub. He asks, will the ABR include AU eligible when someone renews their board cer"cate aer 12-31-23, assuming they were previously eligible?
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0:54:32.310 Maryann Ayoade OK, so even currently, because we do not recognize their re-cer"caon, uh, process, they are not able to issue AU eligible when they renew the board cer"cate. They have to come to NRC with that, along with documentaon of their connuing educaon, because again, it's very case by case or speci"c to the case at hand. And so right now, no, ABR aer this date will not be issuing any cer"cates that will include the designaon for the authorized individuals because there are no longer trying to maintain, you know, their recognion with NRC.
0:55:25.550 Sarah Lopas (She/Her)
OK. All right, now we're "nally going to get to our "rst hand raise. So is it Kenneth? You can go ahead and unmute yourself and I just ask that you introduce yourself, maybe start with your aliaon and then go ahead and ask your queson.
0:55:40.730 Traegde, Kenath (DPH)
Yeah, this is Ken Traegde. Im with the Massachusets Radiaon Control program and I am a supervisor for licensing. I just wanted to ask, as a result of this change, is the NRC going to amend this series of 313 forms with any new informaon based on the ABR cer"caon?
0:56:6.30 Maryann Ayoade Thanks for your queson. Uh, so right now there is nothing that we see that we need to revise in the forms based on this ABR decision or intent to disconnue. And that's because there are sll other specialty boards that we recognize. So that board cer"caon pathway is sll an opon. This is not a change to anything in our requirements.
The training and experience requirements connue to remain the same in both pathways, so no, we are not revising our forms because or due to anything related to this issue. If we update the forms, which somemes we do periodically for other OMB requirements, that would be something separate, but not as a result of this ABR disconnuaon of recognion.
0:57:1.660 Traegde, Kenath (DPH)
OK. Thank you.
0:57:3.270 Sarah Lopas (She/Her)
And Maryann, let me ask a follow up queson from the chat.
0:57:6.790 Maryann Ayoade OK.
0:57:6.170 Sarah Lopas (She/Her) 15
That's kind of related to the 313 form. So John Lichtenberger asks, can you brie"y explain the dierence between NRC forms 313 AUS, AUD, & AUT?
0:57:19.880 Maryann Ayoade Yes. So the form that I presented, the sample form that I used was the AUS and that was for physician authorized user candidates for the 35.400 and 600 uses. Some of the other forms are 313 forms, which we don't always do a good job at highlighng.
Are the 313 ARSO forms? That's easy to remember. Then we have the 313A AMP for the authorized medical physicist or the ophthalmic physicist.
And then we have the 313 ANP for the authorized nuclear pharmacist and then the AUD and the AUT are for physician authorized users for the other types of uses. So for 100, 200, 300 and then for 300, because that's a whole category on its own under 300, it has dierent categories or types of uses. And so, the forms are we tried to or they tried to leter them according to the types of authorizaons or authorized individuals.
But then as you can see, once we get to the AUD AT and AUS, that's where it's for the dierent types of uses 100, 200, 300 or 100, 200, 500 and then a separate one for 300, which is the AUT form and then the form that I use in my example.
The AUS was for the 35.400 and 600 uses, so I hope that clari"es or answers your queson.
0:59:3.440 Sarah Lopas (She/Her)
That's good, Maryann. Thank you. OK. So just a reminder to hit the hand icon on the top right hand side of your screen. If you want to speak out your queson or comment, maybe also put it in the chat.
We're going to. We're going to get through those. So David, you've been waing very paently, David Vassy, you can unmute yourself.
0:59:21.150 Vassy, David Oh, thank you. I'm David Vassy. For 40 years I've been an RSO, at a good sized hospital system and I've brought people onto our licenses both before and during the era of AU eligibility. And so, I would just and I, one of the other speakers menoned that the quality of -- how long it takes to process these requests is somewhat dependent on the quality of the applicaon.
0:59:53.270 Maryann Ayoade Exactly.
0:59:53.510 Vassy, David And you've all seen from what was presented here, the complexity and level of detail of the various 313 forms. So, I would, I'm here just to make a pitch for the fact that if we're going to survive in a post AU eligible world that we've got to "gure out how to make sure that nobody gets out of their residencies without that form already being "lled out before they leave the building. Uh, I worked in a me when AU eligible was not a thing and it is very dicult to get aer the fact accurate informaon about the dates, 16
mes and places and who and the whats. Uh, they've got to come out of their residencies with that informaon recorded and signed o by the appropriate preceptor and so on. So, I would make a pitch. I would I do something very strong-armed, like I would, I would cancel that radiaon or that residency programs license if they don't send those kids out with those forms already "lled out.
1:1:8.0 Maryann Ayoade Thank you, David, for that feedback, and that's you know something that we, you will hear from the ABR if you listen to that video, they're encouraging, you know, their residents and the residency program faculty to encourage their residents to start to do the same thing. And we encourage that as well. Like I said, pracce now to start "lling out the form because you know if you, if you aren't familiar, if you're not as involved with maintaining or keeping track of your training as you move forward towards your board, earning your board cer"cate, you should start now.
1:1:49.410 Vassy, David Yes, ma'am.
1:1:51.490 Sarah Lopas (She/Her)
Right. Thank you, David.
1:1:53.580 Vassy, David Yes, ma'am.
1:1:53.770 Sarah Lopas (She/Her)
That's it.
1:1:54.220 Vassy, David Thank you.
1:1:54.990 Sarah Lopas (She/Her)
Good advice. This is a general T&E queson. This is from Jonathan Porter -- is training/experience in Canada considered valid for this form given that preceptors and supervisors are generally not NRC designated AUs, but the Canadian equivalent?
1:2:14.210 Maryann Ayoade That's a good queson, and you may, Jonathan may have already responded to some of your queson with foreign trained individuals. In this case, physicians, we don't have a recognized specialty board from Canada for the physicians, the Specialty Board that we recognize is for the physicists right now. And so what that means through the board cer"caon pathway or even outside through the alternate pathway, is that what the block or the challenge for Canadian or foreign trained physicians is that supervised work experience and also the preceptor that's going to be signing o on the training and the 17
work experience. And so it does have to be the training has to be supervised by an authorized user, and that's where it has to be from an NRC agreement state licensee.
1:3:15.860 Sarah Lopas (She/Her)
Right. Thank you, Maryann. Here's that queson from Kevin Nelson. Does NRC expect a shortage of AUs in the years to come now that ABR cer"caon will no longer be recognized?
1:3:31.960 Maryann Ayoade Thank you, uh, Kevin for that queson, that is a good queson. That's something that we are going to be on the lookout for. That's something that has been in discussions with our advisory commitee, as I menoned, and you will see that they did have that discussion. If you look at the meeng transcripts and their report right now, you know we are again just looking out for what to expect as a result of this. And so it's on our radar because we know ABR is a board that, you know, holds a lot of candidates and dierent specialty areas. And so we're on the lookout for that right now. And we are looking, we have our ears through the ground and we're going to be listening to see what to expect as we move forward.
1:4:24.10 Sarah Lopas (She/Her)
Thank you.
1:4:23.810 Celimar Valenn-Rodriguez (She/Her/Hers)
Maryann, and I just wanted to add, I think you've reiterated this point throughout the presentaon, but the alternate pathway is sll available to anyone who wants to become an authorized user and authorized individual. And also umm, you know you can actually work under the supervision of a current authorized user. So in that terms, unless you're actually going into an AU role.
If you're sll working under the supervision of any AU and you do not want to become an authorized user at this point, you, that pathway is sll available for those who don't want to atain that designaon, so.
1:5:2.640 Sarah Lopas (She/Her)
Alright, I'm going to read two comments. I think by the same person, unknown user. If oered, would it be possible for AU candidates to take the RISE exam via third party exam site and submit their results and ABR cer"cate to sasfy the same requirements and then the follow up I think is since the ABR will connue to include the rise poron in their exam, will the NRC recognize this training to be used to complete the required NRC forms? OK.
1:5:39.30 Maryann Ayoade Sir, I don't think I caught all of the second part of your queson because I see it was OK. I see it.
1:5:46.120 Sarah Lopas (She/Her)
Yeah.
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1:5:44.50 Maryann Ayoade It was submited aer, OK so but I can start with the "rst part. So again, currently, because our regulaons were for the dierent specialty boards and they're supposed to maintain or meet our criteria, right? Right now, we do not have any, you know, opons to receive informaon from a third party that, as you pointed out, may be able to do, you know, similar or what it is that ABR has oered as far as what gets you the AU eligible. So right now, we do not have an opon for that or a pathway for that. It's a comment that we're going to take back and consider, and I don't know if Celimar, if you wanted to add anything to this one.
1:6:38.740 Celimar Valenn-Rodriguez (She/Her/Hers)
No, I think for this. You know, if I'm reading it correctly, I think what's important is to look at our requirements and make sure you ful"ll those requirements. I think what the RISE examinaon and the process that ABR submited to us is speci"c to their own cer"caon and their own special specialty process, recognion process. So, I mean, I always point people to our requirements and that's what really you need to meet and that's what you need to submit. So, anything that you would comply with during your compleon of an ABR cer"caon, you can keep the 313 form and use that to kind of keep track of that training and experience and use that towards your alternate pathway applicaon.
1:7:30.810 Maryann Ayoade Yeah. And I can add cause I just, Sarah, I just got to the second part of the queson that says since the ABR will connue to include the RISE poron in the exam, would NRC recognize the training to be used to complete the required NRC forms and to respond to that because ABR has made the decision to no longer maintain the recognion, we can't put them on hold. If we change our regulaons and they're not meeng our regulaons, right, and so we can't sll hold that RISE poron of the exam or any part of their cer"caon process to the same standard that we're holding them to now because they're recognized.
And so again, all of the informaon that would be, would have been submited to the boards to be able to sit for the exam is what you would have to sll submit to NRC because we're going to be the ones reviewing the training records to make sure that each individual has sas"ed the requirements.
We're not. What? What's happening is that we're not pung it on the American Board of Radiology anymore to maintain that they're meeng our requirements. So just wanted to clarify that.
1:8:47.900 Sarah Lopas (She/Her)
I think I'm going to follow up with the related queson. The queson is kind of related to this, so Suke Patel asked, are there any NRC recognized training courses available for AUs to meet the T&E requirements?
1:9:5.210 Maryann Ayoade So I'll have Celimar follow up with me on this, but I know we have courses for our regulators. So, for our license reviewers at NRC and you agreement states to be able to review and approve, but we do not have that. I'm aware of have a generic licensing course for non-regulator sta.
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1:9:34.150 Celimar Valenn-Rodriguez (She/Her/Hers)
Right, and we don't, we do not endorse any training and experience or courses from outside organizaons. So, if your queson is if there's any course that a physician could take to comply with our T&E requirements, we don't endorse or review any of those types of courses. So, you would have to go through your medical state board or through some professional society and look at what they oer or any courses that they may endorse. But the NRC does not endorse any training courses.
1:10:4.880 Maryann Ayoade And I know that a couple of the professional sociees have started having conversaons of what they want to oer or put out there to help their dierent members that are associated with their, with their sociees, so.
1:10:21.640 Sarah Lopas (She/Her)
Right. There's a related comment here in the chat that says SNMMI had a few 80 hour9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> AU courses.
So. Umm OK, I am going through the chat and it looks like some people are giving hints for how to decipher the AU. The 313 forms a AUT therapy, AUD diagnosc and I am looking for any addional quesons here. There, see. I don't see anything.
1:10:55.440 Celimar Valenn-Rodriguez (She/Her/Hers)
I don't see anything else, Sarah, that we haven't addressed.
1:10:58.980 Sarah Lopas (She/Her)
No, I don't see anything else either. OK, one more, one more, just popped up maybe. Oh John, John, you had a number. Let's see. So, John, your queson was, I think yours was a speci"c a speci"c queson here, John. I'm trying to "nd it, no.
1:11:16.90 Celimar Valenn-Rodriguez (She/Her/Hers)
Yeah. His queson was what form for diagnosc radiologists. So, I guess what 313 form?
1:11:23.170 Maryann Ayoade So that would be the form for uses under the diagnosc right, so 100, 200 and so that would be the AUD as people reminded me. Yes, the designaons S, T, & E are for diagnosc therapeuc and sealed source related types of uses.
1:11:45.290 Sarah Lopas (She/Her)
Have.
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1:11:47.240 John Lichtenberger (Guest)
Umm. And if they do iodine, they also have to do a AUT, so 2 forms.
1:11:51.950 Maryann Ayoade It depends on what they're requesng for, if theyre requesng for uses of iodine with less than 33, greater than 33. But yes, the AUT form is for the 300 uses in general, and then you have to "gure out the types of use that you're requesng, or if you're requesng use under all the categories in 300.
1:12:16.350 John Lichtenberger (Guest)
And if that's true, all the categories is 2 separate forms.
1:12:24.720 Maryann Ayoade If it's all the categories under just 300, then it's the AUT form. When you "rst menoned diagnosc radiology, I wasn't sure if you were looking to do other things beyond 300, so in 100 and 200.
1:12:36.830 John Lichtenberger (Guest)
But OK, thank you.
1:12:38.500 Maryann Ayoade So you're welcome.
1:12:42.40 Sarah Lopas (She/Her)
Great.
1:12:43.550 Sarah Lopas (She/Her)
And related to this, Celimar maybe just um, I know you menoned that I think we're doing some, we're issuing some sort of guidance T&E "lling out these forms or some sort of guidance, right? That's coming.
1:12:58.350 Celimar Valenn-Rodriguez (She/Her/Hers)
Yes.
1:12:56.440 Sarah Lopas (She/Her)
Maybe this coming summer or I'm not sure.
1:13:0.70 Celimar Valenn-Rodriguez (She/Her/Hers)
Yeah. So, we're preparing implementaon guidance, this will, this can be used by licensed reviewers and NRC agreement states, but also by licensees and even individuals who are seeking authorized status.
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We'll be clarifying roles and responsibilies of people who are involved in training and experience. So, what's your role as an AU versus what's your role as an AMP or so, etc. You know, we always get a lot of quesons about how to count hours towards work experience casework, that kind of thing. So, we'll try to provide some clari"caon there. Clari"caon on supervision. So, it's just, it's a bit more than just "lling out the forms, but there's going to be a lot more informaon in that guidance to kind of help answer some of these quesons that we see from me to me and that will hopefully assist folks in providing beter responses and or beter record keeping or 313 forms. So that should be coming to you all next year. And I just want to remind people that our NUREG-1556, volume 9, Revision 3 also has informaon about the dierent pathways for becoming authorized individuals that has checklists and also informaon about what you need to submit depending on what type of use, what type of authorizaon you're seeking. So that's a really good resource for now. And so that's something that folks can use in the meanme as well.
1:14:30.790 Marc Benayoun And.
1:14:30.350 Sarah Lopas (She/Her)
And. Who's that speaking?
1:14:34.660 Marc Benayoun Sorry, I had my hand raised but I don't know if it went down or it's like.
1:14:37.770 Sarah Lopas (She/Her)
Uh, yeah, I don't see it. You could just introduce yourself. But is that Mark? Hi Mark.
1:14:41.980 Marc Benayoun Yeah, it's me. I'm a professor, head of nuclear medicine at Wake Forest. So, I've got a lot of radiology residents who are going to be looking at me as their AU preceptor. And I just, you know, looking at it carefully, like if I look at any of these 313 forms, I'm going, it used to be that I would "ll out the "rst part where it said board cer"caon because we were going to provide an AU eligible cer"cate. I'm assuming now I have to skip down to the third opon where it, you know, it doesn't talk about.
1:15:16.730 Maryann Ayoade Yeah.
1:15:12.330 Marc Benayoun It's like I think that's what you guys mean by the alternate pathway where I'm pung in all the details of radiaon physics and instrumentaon training, etcetera, correct, right.
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1:15:20.730 Maryann Ayoade That's correct.
1:15:20.490 Marc Benayoun I'm just going to "ll out the botom part now instead of the top. That's literally what, that's all we're really doing dierently.
1:15:25.890 Maryann Ayoade Primarily, yes, you do sll need to include.
1:15:31.470 Marc Benayoun Sure.
1:15:28.240 Maryann Ayoade You know the individual's name and the type of use that that "rst part of the form. But yes, that's the alternate pathways item, I think I there's three and the "rst page of the form, so item 3 should be for the alternate pathway.
1:15:42.970 Marc Benayoun OK.
1:15:44.650 Sarah Lopas (She/Her)
OK. And I think some of these quesons might be very now into more kind of speci"c sort of quesons that might be best for your regulator. But maybe we can "nish up with a couple of these quesons so.
313 -- This is just a statement and I don't know if Maryann or Celimar wanted to comment on this.
313 forms are not designed for microspheres. Those are regulated that are 35.1000 emerging technologies. And then I think a follow up queson is can we then use internal preceptor forms for Y-90 microspheres? That's generally what we do. Then have the preceptor write a leter.
1:16:25.570 Maryann Ayoade Yeah, and that's "ne.
1:16:29.330 Sarah Lopas (She/Her)
OK.
1:16:27.410 Maryann Ayoade There we can take these quickly. So, I think I'm seeing there's a bunch of other comments as well related 23
to this. Uh, we do not have designated 313 forms for any of the 35.1000 uses, but we have had people try to use the 313 forms to "ll out for microspheres. Use. Some people do not enjoy doing that.
We are currently at and I believe Celimar menoned that we are, there is a potenal or ongoing rulemaking for emerging medical technologies. In general, we have chosen not to create forms for the technologies on the 1000 because they're always changing. Microspheres, for example has so many revisions right now, and so those forms would have to have been updated a lot and so our goal is to, once we, depending on the way the rulemaking goes once it's codi"ed, then we will look into having a set 313 forms for the type of use, whether it's microspheres or you know, beyond, so.
1:17:37.950 Sarah Lopas (She/Her)
OK. Thanks, Maryann and 1 last hand raise. Ron, you can go ahead and unmute yourself Ron Parsons.
1:17:48.340 Ron Parsons (Guest)
Uh, yeah. I was just wondering if, uh, seeing you had a litle blurb about pung informaon on the medical list server. Is that an informaon noce, or are you not doing that?
1:18:3.360 Maryann Ayoade So some I don't know if you were trying to, if you were about to say something, I could start on the medical list server is not what we call our formal generic communicaon or type of informaon noce.
It's just a portal of how we send out all kind any or all informaon related to medical informaon.
Noces are a separate type of NRC generic communicaons, and so I'm not sure if you're asking if we're pung anything out in an informaon noce or via the medical list server. We do send all, any kind of announcements that we have to make to the general public using our medical list server portal, so.
1:18:51.180 Celimar Valenn-Rodriguez (She/Her/Hers)
No.
1:18:50.590 Ron Parsons (Guest)
Yeah, I was asking if you were going to send informaon noce.
1:18:54.220 Celimar Valenn-Rodriguez (She/Her/Hers)
Work.
1:18:54.920 Maryann Ayoade OK.
1:18:54.600 Celimar Valenn-Rodriguez (She/Her/Hers)
It's something we're considering, Ron. We'll de"nitely be sharing the STC leter to agreement states, but I 24
think you're asking for an informaon noce because that would go to all licensees versus just regulators, so that.
1:19:6.810 Ron Parsons (Guest)
That we send those out prety quick and we generally atach the NRC informaon noce.
But if y'all don't send one, we're probably going to send our own.
1:19:17.50 Maryann Ayoade OK. Right.
1:19:17.20 Ron Parsons (Guest)
Umm, so we were just wondering general what we do is we atach the NRCs informaon noce, send it to our licensees just to let them know of major changes, something this prety major change. But if y'all don't do one, then we're probably going to do one here prety soon because December 31st coming prety quick. So, I was just wondering if that's in in the works and if you'll have any meframe on that.
1:19:44.10 Celimar Valenn-Rodriguez (She/Her/Hers)
It's something we're considering. Um, because since we usually use informaon noces to share operang experience. But in this case, that's something we're considering now. So, if we were to issue that, it would probably be around the me when we send out a no"caon. So, by the end of the year, if we were to do one.
1:20:3.450 Ron Parsons (Guest)
And that disconnuaon of what you said youre going to post on the medical list server when the disconnuaon is "nalized? That'd be aer December 31st, right? That'd be when it actually happens.
Or would that be before?
1:20:21.810 Maryann Ayoade Yeah.
1:20:18.480 Celimar Valenn-Rodriguez (She/Her/Hers)
Maryann, I think we're thinking about sending it before, correct, because that would be a leter to the ABR.
1:20:26.260 Maryann Ayoade Yes, that's correct. And that's, I believe I menoned in the presentaon in November, December me frame.
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1:20:34.380 Ron Parsons (Guest)
OK. Thank you.
1:20:34.420 Celimar Valenn-Rodriguez (She/Her/Hers)
But it will also be updang Ron. We'll be updang our page where we post our specialty boards and we'll make sure that that page is also updated so that leter can be available to anyone on the public website.
Yes.
1:20:58.690 Maryann Ayoade Yeah, that is publicly available, so yeah.
1:20:59.10 Ron Parsons (Guest)
OK. Thanks.
1:21:7.490 Sarah Lopas (She/Her)
OK. Umm, I think with that and I'm looking through the chats again, I'm just seeing some chat amongst the parcipants. That's great. I wish you all had your own litle separate site where you could all share your experiences with "lling out these forms and whatnot, but at this point I'm going to turn it back to Maryann or Celimar to close this out.
1:21:33.920 Maryann Ayoade Tell him.
1:21:34.830 Celimar Valenn-Rodriguez (She/Her/Hers)
You.
1:21:34.280 Maryann Ayoade I don't know if you wanted to go ahead.
1:21:36.620 Celimar Valenn-Rodriguez (She/Her/Hers)
No, I was just going to say thank you to everyone who stayed past 3 O'clock. I know this meeng was originally scheduled for one hour. We "gured we'd provide a lot of informaon to you all up front because we are recording this. Umm, this meeng. We're also transcribing it, so we hope to make that available to you all. I thank you for sharing your experiences, for sharing your quesons. As Maryann has reiterated during her presentaon, please reach out to your regulator if you have any speci"c quesons.
Also, reach out to us at medicalquesons.resource@nrc.gov if you'd like to sign up for the medical listserv. If you go to the link that was posted for the NRC's medical toolkit in the chat that has an opon to subscribe to the medical list server, we usually send out informaon and any publicaons that are publicly available through that through that list server. So, you don't expect to be receiving, you won't be 26
"ooded with no"caons from the NRC. But that is a way to maintain contact with us here in the medical team.
So again, I want to thank Maryann for her through presentaon. She's our subject mater expert on training experience here at the NRC and she is our lead for emerging medical technologies, rubidium-82 generator rulemaking, so she's very busy, but she's also very knowledgeable and I really want to thank her for her command of the informaon provided today. So, with that, please again if you have any quesons. Medicalquesons.resource@nrc.gov and we'll de"nitely send out a no"caon through our medical list server when our transcript for this meeng and the slides and the recording is available.
And we'll post that to the medical toolkit. So, they will both be publicly available.
So, thank you all. And Maryann, if you want to have some parng words, if not, then we'll adjourn the meeng.
1:23:30.320 Maryann Ayoade No, thank you all and we look forward to helping to answer any quesons that you might have.
1:23:36.360 Traegde, Kenath (DPH)
Thank you.
1:23:39.600 Sarah Lopas (She/Her)
I thank you everybody. Bye bye.
1:23:40.810 Celimar Valenn-Rodriguez (She/Her/Hers)
Thank you.
1:23:44.30 Chelsea L. Smith Thank you.
The meeng concluded at 3:23 PM.
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