Meeting Transcripts Meeting Proceedings[217]

Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION Title: Advisory Committee on Medical Uses of Isotopes: Subcommittee on Remote Afterloading Docket Number: (not applicable) Location: Rockville, Maryland Date: Thursday, September 28, 1995 Work Order No.: NRC-339 Pages 1-277 NEAL R. GROSS AND CO., INC. Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W. Washington, D.C. 20005 (202) 234-4433 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ALSO PRESENT: JUDITH ANNE STITT ROBERT M. QUILLEN MEMBERS PRESENT: UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION + + + + + ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) + + + + + SUBCOMMITTEE ON REMOTE AFTERLOADING + + + + + THURSDAY SEPTEMBER 28, 1995 + + + + + ROCKVILLE, MARYLAND + + + + + The Subcommittee met at the Nuclear Regulatory Commission, Two White Flint North, 11565 Rockville Pike, Room T2B3, at 8:00 a.m., Judith Anne Stitt, Chairman, presiding. 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 LARRY CAMPER TRISH HOLAHAN ROBERT AYRES TORRE TAYLOR SALLY MERCHANT 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Agenda Item Radioactive Material, Item 6 . . . . . . . . . . . A G E N D A Page 28 Purposes for which Licensed Material Will Be Used, Item 7 Authorized Users, Item 8 . . . . . . . . . . . . . . . . . . . . . . . . . 36 43 Training for Individuals Responsible for Remote Afterloading Brachytherapy, Item 9.1.1 Training for Nursing Staff, Item 9.1.1.1 . . . 84 96 . . . . . Normal and Emergency Operation of HDR RAL device(s), Item 9.1.1.2.2 . . . . . . . . . . . . . . . . . 100 126 137 142 142 168 170 175 185 190 196 239 247 256 259 Training for Ancillary Personnel, Item 9.1.1.3 Training Contractors, Item 9.1.1.4 . . . . . . . . Records, Item 9.3 . . . . . . . . . . . . . . . . . Facilities and Equipment, Item 10 . . . . . . . . . Viewing and Intercom Systems, Item 10.1.1.2 . . . . Survey Instruments, Item 10.2 . . . . . . . . . . . Security of RAL Devices and Sources, Item 10.5 . . Radiation Safety Program, Item 11 . . . . . . . . . Implant Source Record and Inventory, Item 11.14 . . Area Survey Procedures, Item 11.15 . . . . . . . . . Operating and Calibration Procedures, Item 11.20 Maintenance of RAL, Item 11.22 . . . . . . . . . . Radioactive Waste Management, Item 12 . . . . . . . Returning Sources, Item 12.3 . . . . . . . . . . . 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: Good morning. P-R-O-C-E-E-D-I-N-G-S (8:28 a.m.) I am Larry Camper. I am the chief of the Medical Academic and Commercial Use Safety Branch, and the designated federal official. This is a subcommittee meeting of the Advisory Committee for the Medical Uses of Isotopes. This meeting was noticed; it's a matter of public record, in a Federal Register Notice published on the 21st of August, 1995. With me here today, two members of the Advisory Committee, and Dr. Judith Stitt, who will act as the chair of the subcommittee meeting today. And Mr. Robert Quillen, who Also is our states representative to the Advisory Committee. we have Dr. Robert Ayres, who is a member of the Medical Academic and Commercial Use Safety Staff, Dr. Patricia Holahan, member of the staff; Sally Merchant, a member of the staff; as well as Torre Taylor, who also serves as the administrative coordinator for the Advisory Committee on Medical Uses of Isotopes. This is the second subcommittee meeting in a series of three meetings. The first was held yesterday, and the purpose of the subcommittee meetings is to discuss a number of guidance modules that have been prepared by the staff to be added to the existing Regulatory Guide 10.8, which is the so called medical licensing guide. 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 proceed? MR. CAMPER: MS. STITT: Go right ahead, Madam Chair. Well we have in front of us the Today we'll be discussing the guidance module entitled, Remote Afterloading Brachytherapy Module. This module is a revision to policy and guidance directive FC 86-4, which underwent substantial revision updating, following a significant medical event in Pennsylvania 1992. This guidance document has been discussed in some form through a document identified as the brachytherapy issues paper with the Advisory Committee in total previously as well as with a number of professional societies. Currently these guidance modules are undergoing review and development, as I said for addition to 10.8 and will ultimately be included in a licensing manual, which is being prepared as part of our agency's business process reengineering initiative. So with those comments then I would ask Dr. Stitt if she would assume the chair of the meeting and we can proceed. MS. STITT: Good morning. How do you want to remote afterloading brachytherapy module, and if I understand right this is somewhat informal, but we're asked not to all talk at the same time. and keep turning? MR. CAMPER: That's fine. So do you suggest we start with page 1 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 nature. page 1. MS. STITT: And there are different colors of markers and handwritten notes on our personal copies, so I think that's what we're going to be working from. Should we just start on page 1. And do you want to make comments about certain things you're looking at there, sir, Dr. Quillen? MR. QUILLEN: Actually I have no comments on Those were just things to alert me and remind me of items that I needed to consider later on. MR. AYRES: I might make a general comment, this one's a little different than any of the others in that our region and other comments just came in and have not been incorporated. So I have a folder full of comments already. Is it worth trying to bring you those MS. STITT: up here or is that too convoluted? MR. AYRES: They're mostly of an editorial The only I guess policy issue really that's in these are some OGC stuff, which will have to start out -- is the state of Illinois comments. They're proposing much more stringent requirements on PDR than are in this module. MR. CAMPER: What I'd like to do on that, Bob, if In the we could, is yesterday we also had some comments. meeting yesterday we discussed mobile medical imaging module and -- What was the second module we discussed yesterday? MS. HOLAHAN: Radiopharmaceutical; radioactive 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 drug therapy. MR. CAMPER: drug therapy. We did have a number of comments from the regional staff on those modules, and we did share those comments with the committee members yesterday. I'd like to That's right. Radiopharmaceutical make sure that we also do that today; share those comments with the subcommittee members. And if the opportunity presents itself later in the day, to even perhaps take a look at any major issues, if there are -- If it's all editorial then fine, but if there are any substantial technical issues in there it would be nice if the committee could at least have an opportunity to glance through them to see if they have any thoughts about it. MS. STITT: Well Trish, I assume you have comments you're piping up, is that right? MS. HOLAHAN: MS. STITT: Yes. Just in general, a lot of this -- I It seems to mean this is not particularly new material here. be a different format for some of the things that we have in Part 35 and shuffling other things around, so I'm not sure how emotional we may find some of our meeting today. MR. AYRES: It's a rewrite of our current policy and guidance directive, with a few changes, and mostly minor, except a couple of them are relatively subtle, such as, the 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 bulletin had a requirement. changes from -MS. STITT: All right. Particularly those subtle If you'd like I can summarize the ones that maybe if we haven't enough coffee we didn't catch. MR. AYRES: From the current policy and guidance directive, one of the more subtle changes is the bulletin and the current policy and guidance directive called for the presence of the authorized user and the medical physicist or RSO. We deleted "or RSO". So we've implied that medical physicist is now required. MS. HOLAHAN: acceptable -MR. AYRES: A super alternative, and what I've Do we allow them to propose an provided in the way of guidance in this regard has normally been say a dosimetrist or something, similar professional that has had the specified training normal in emergency procedures on a device. For an authorized user we go along with a resident who's been trained and that sort of thing, or the next tier down in the professional level. One of the other things I deleted because technically it's not reasonable anymore because the size of these sources have gotten so small I deleted the requirement for checking the homogeneity of the source. MS. HOLAHAN: And that was discussed with the full ACMUI when we had the two physicists present? 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MS. STITT: MR. AYRES: Right, that was our last meeting. We had a discrepancy between 35.400 and the guidance in the bulletin on the appropriate serving instrument to use, and we decided to go with the bulletin guidance in lieu of the 35.400, so we have a licensed condition in lieu of exemption. I maintained all along that it was more appropriate to use a non-saturable iron chamber type instrument rather than a geiger saturable type instrument. MS. STITT: whole committee? MS. HOLAHAN: That's true. The one thing as Bob And we discussed that in front of the mentioned is, that it does a require an exemption to the regulations, currently, because we have not changed the regulations. process. MR. AYRES: deal with that one. MS. STITT: MR. AYRES: Are you dealing with that? Well I just got these comments in the I got some of them yesterday, and I OGC's querying that, so we'll have to But that can be done as part of the licensing last three or four days. still haven't got these two. MR. CAMPER: I'm sorry, Bob, help me out here. They're querying the need for the exemption? MR. AYRES: Yes. They're querying the 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 with them. I guess the only other significant one in here is allowing -- and Trish has written some guidance on this, and it's not incorporated in here. But allowing them to ship more have? MR. AYRES: Yes. From OGC's comments it's clear need -- Well actually, Marjorie is -- querying the need for all exemptions to 35.400. MR. CAMPER: Are they necessitated? MR. AYRES: Well, it's just more of a question -In the sense of, are they warranted? She's saying, well why doesn't it apply as written, and she doesn't understand the technical. MS. STITT: They need information that they don't that they don't understand that technically the 35.400 requirements as written cannot be met. MR. CAMPER: MR. AYRES: Oh, I see, okay. I think we'll have to work that out activity than can be installed in the device, so that for the convenience of the vendors and the users so that they can ship 12 curies. They can ship whatever the shipping container is certified for, but can't install anymore than the safe and the device is certified for. So I think pre-ship say 12 curies and schedule the installation at the time the source reaches 10 curies. 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: Bob, would you comment on the surgical intervention issue? MR. AYRES: MR. CAMPER: It hasn't really changed. But the point is, one of the things I want to try to make sure when we get to that point today is get some feedback from the committee, particularly from Dr. Stitt, is this idea that in doing procedures involving HDR, if you're involved in a procedure where a source could become lost in the patient's body that may necessitate surgical intervention to remove it I'd like to get some thoughts as to the way the guidance is currently structured. Is that a reasonable requirement? Is it a situation where we're not imposing upon medical practice or problem? MS. HOLAHAN: Okay. I just wanted to say, I don't believe at this time in the guide that we specifically say that you cannot conduct procedures unless you can do surgical intervention, and I guess the question is, is should we. Is that correct, Bob? MR. AYRES: say, 80 percent. Well, most the licensees do, I would But most of the licensees; That's a guess. response to that requirement is, is we do not do procedures that would require surgical intervention, and they primarily predicate on that the source is always enclosed in the transfer tube applicator system. Where we of course know 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 there have been multiple failures of transfer tube applicator systems. So it's a little bit of a concern, but we say, okay. You say -- Unfortunately it's a little bit of that philosophy, it can't break, that contributed to the Pennsylvania incident; the source can't break. Well, basically what most of the licensees are maintaining is, the containment system, the applicator transfer tube, can't break. multiple instances where they have. And we in fact know of So we take -- we say, just plan for it, and have at least something in mind if something goes drastically wrong. MS. STITT: And as I was reviewing this, the two aspects of an emergency -- and Trish, you addressed this in the document that you put together. medical and one radiation safety. The two aspects being one And is an institution prepared to address both those aspects. MS. HOLAHAN: I think this comes up particularly in the cases that we talked about before with prestanding clinics and something like that. And I know the question and I've sort of tried getting again some feedback too. Even though, as Bob says, it indicates that the source is enclosed are there possibilities, for example, endobronchial, that it could actually get caught or something and no longer be enclosed, and I have gotten some indication that it is a possibility. So what is a licensee prepared to do, or what should a licensee be prepared to do in those cases? 13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Procedures. MS. STITT: And in the draft that we're looking here, the remote afterload and brachytherapy module, there is not a statement or is it real vague? MR. AYRES: MS. HOLAHAN: MS. STITT: referring to? MR. CAMPER: Item f of 11.21, Emergency B, is somewhat Yes, there is. About what's required? Section F? Is that what you're There are really two things. indirectly applies, but F is the more direct consideration. And as Trish pointed out, if you look at the words, it says identify the location of emergency source recovery equipment and specify what equipment may be necessary for the various equipment failures described in the procedure. At a minimum emergency equipment should include shielded storage containers, remote handling tools, and if appropriate supplies necessary to surgically remove applicators or sources from the patient, including scissors and cable cutters. Now, that doesn't go all the way, if you will, of saying, if you're going to do a procedure in which there's a potential for the source to be lost in the patient's body you must be prepared to intervene surgically if need be. And a fundamental question for us, and it's a terribly important medical question is, if were to take a stronger posture along that line would that be acceptable to the medical community, 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 covers it. issue. would be walking on the practice of medicine, or would that be a reasonable regulatory request under those circumstances? MS. HOLAHAN: Because there is a radiation safety issue associated with it obviously. MS. STITT: MR. AYRES: Right. I was just going to say, the other area that's not addressed here because it gets closer to the practice medicine I guess if you will although it's a radiation safety consideration, is do they have a plan to respond to a medical emergency not related to the HDR, but involving the HDR, and that is not covered here. MS. HOLAHAN: MS. STITT: During patient treatments. Of course the HDR isn't the only The more critical But this module This is a remote afterloading. issue becomes HDR because of it's high doses. in general applies to any remote afterloading. MS. STITT: This section of emergency procedures It doesn't have some of the detail that you -- If you've got a true radiation safety emergency with a high dose rate source, you in theory would need to be doing a thoracotomy, or another example was the case that we've been through with the prostate implant. emergency. That was a medical Well, it was a radiation safety emergency, and that patient had a surgical removal of those seeds of radical prostatectomy within five hours or something like that. And 15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 whether they had written procedures it described that's what they would do ahead of time. the event occurred. Some of my question has to do with how specific do we have to get in these to tell folks that you have to think about this ahead of time. MR. AYRES: With the remote afterloading I guess That is what they did do when part of the -- one of the considerations for leaving that out. Normally you would expect the devices to automatically retract the sources when you're responding to a medical emergency, to have a radiation emergency in conjunction with it would require a medical emergency which could do induce in equipment; kink the tube or something. But it would require that medical emergency to precipitate a failure in the device through the ability to retract the source, then creating your radiation emergency to go along with the medical emergency. MS. STITT: A question to ask of the staff, and If this comes just in the form of a clinical circumstance. this is what we end up with, which does touch on all those aspects, although it doesn't say, give me the name of your thoracic surgeon; it doesn't get that specific. But in example, let's say a free standing clinic somewhere that's doing high dose rate endobronchial, because that's a very common procedure. It's done in lots of places. If there's a source problem, if it's one of the clinics that my institution 16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 operates at there is no thoracic surgeon in the area. would be within a few hours. How much goes into this language and how much is left implied? MS. HOLAHAN: Well let me ask you another case, There because some of the responses that we had is, well a thoracic surgeon won't go into the patient if there's a source in there. MS. STITT: MS. HOLAHAN: That's the other response, yes. Is it sufficient to say that the authorized user would need to be able to do something in an emergency situation, or would an authorized user -- I mean could somebody other than a thoracic surgeon do the type of intervention you're talking about? MS. STITT: No. I mean the thoracic surgeon could crack the chest and get close anatomically, and then the authorized user could fish around. record, doesn't it? MR. CAMPER: matter here. But you're at the heart of the It sounds bad on the If you look at that what that really says in a private, free standing facility. MS. STITT: university hospital. MR. CAMPER: It could, but at least in that Well it could also happen at any setting you have access -- reasonable readily, you have 17 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 access -MS. STITT: interest in -MR. CAMPER: to a surgical suite. Right. But at least you have access You have access. You may not have Even though you don't have access to a thoracic surgeon you probably have access at lest to a general surgeon. You have a surgeon involved. But by contrast if you're in a free standing facility and you have an authorized user who is a therapist and this event unfolds you have an immediate, significant medical emergency on your hand. So then you have to ask yourself the philosophical question. procedure? Should they be doing such a Well they might respond by saying, yes, we an do this with a high degree of confidence because we assume the potential for failure of this type is extremely small in view of the design of the equipment, the catheters in particular and so forth, therefore we have a high degree of confidence in doing the procedure. Well that's okay, but unfortunately that one single event, even though it may be 10-4, when you have that single event you've got a problem. So then the question becomes for us as regulators, to what extent should we address this in the guidance? It would be inappropriate to impose a condition that says, thou shall be prepared to surgically intervene, 18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 because I think that's a medical judgment call. The question -- in advice space and guidance space, to tune them to the idea that, if you're doing these types of procedures you need to be prepared to intervene surgically. Now, we hint at it here by saying if appropriate, dah dah dah. MS. STITT: clue people in? MR. CAMPER: MS. STITT: Well, that's a possibility. Such a case might be recovery of a Should you put examples? Will that source that has broken off or a source become dislodged in a lung, and you might give some examples. It doesn't mean that it's -- you're dictating what they have to have available. But you can read these things on a lot of different levels. You can think of a source in a intracavitary vaginal applicator and that's much simpler to retrieve than a small iridium source that got dislodged in the right lung somewhere. MR. AYRES: We presume that in most vaginal cases the authorized user could easily remove the applicator. MS. STITT: My comment about an example, would at least tip the reader off to some of the most difficult cases to try to retrieve. To bring up another area along this same line of potential problems would be the intravascular use of high dose rate brachytherapy sources. That is HDR sources are being 19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 by the way. MS. STITT: MR. CAMPER: Today? No, at the upcoming ACMUI meeting. from there. MS. STITT: MS. HOLAHAN: MR. CAMPER: Okay. Yes. We are going to explore that topic Marcy Richards? only -MS. HOLAHAN: Because I spoke with the physician used or plaque therapy in vessels -MR. AYRES: That's an emerging field right now. We're kind of working with FDA and trying to be prepared in advance. But it's all experimental now, and the FDA's going The only one that both of to require IDs and the whole thing. us are aware of that's currently going on is at Scripps. MS. STITT: Are they doing it? How about Milwaukee at St. Lukes? I thought they were. They are hoping to do it. I don't MS. HOLAHAN: know if it's actually been approved for them to do it yet or not. MR. AYRES: Well as far as FDA knows, they We're going to talk about the intravascular -MS. STITT: Well the timing will be good because there is a subcommittee that's meeting at the ASTRO, which is the national radiation oncology group coming up shortly. 20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 day. MS. STITT: their mascots. MS. HOLAHAN: I was just going to go back to the They have fuzzy animals that are organize. MR. AYRES: MR. QUILLEN: MR. AYRES: MR. QUILLEN: MR. AYRES: I forget which one. MS. STITT: MS. HOLAHAN: They're all kind of the same there. Yes, they had a workshop on that It's led by Coffey. Joe Coffey? Yes. He was in Kentucky. No, he's with Midwestern University, MR. AYRES: MS. STITT: APM formed the committee also. And that's at least on the books to advantage of putting the examples in, because that also, sort of provides -- Some of the questions that I think we've sort of all heard is, why does the authorized user have to be present because there might never be a case where -- I mean it's the physicist who would be the individual going in. For example, a vaginal applicator as a physicist is not going to want to pull that out of a patient in an emergency. MR. AYRES: MS. HOLAHAN: Well in an emergency -By putting examples in it helps just reemphasize the need for the authorized -- 21 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MS. STITT: And it also gives people some things They may think of what that might not have thought about. they do most frequently, but not of some other circumstances that you might get into. MR. CAMPER: I'd even go a step further, I think physicists generally would be uncomfortable in intervening medically in any fashion. I mean the physicists, I am willing to bet, will look at their role as dealing with the radiological side, the source problem, the functioning of the unit, etc., etc., because clearly, there's a liability issue here. MS. HOLAHAN: comments we received. MR. AYRES: And I think it's very appropriate I was just referring to some of the because also the physician is often uncomfortable dealing at a detail level with the machine; the understanding of error messages and peculiar modes of operation and so forth. So what the whole thrust was, was to try and stay in state and regulatory language, which the authorized user and a physicist -- We want a medical expert and a machine expert there when treatment's going on. that way, in regulatory space. MS. STITT: MR. AYRES: Why can't you? Well you have to define, and then But you can't quite put it you'd have to define -- we'd have to go further than our 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that I had. MR. CAMPER: So Item F of 11.21. We'll be regulations currently do and define medical expert, which we really sort of do with the other end, but define machine expert. Since we're not writing new regulations we're trying to make this fit. MS. STITT: Well the two aspects of emergency really do come down to medical and radiation safety and I don't know that you have to necessarily define, but just to make people realize and you can again use an example to indicate that. I think we could use what we've got here which is nicely stated and then refine it by using some examples. MR. CAMPER: MS. STITT: Okay. Those certainly were the comments looking at Item 2F of 11.21, adding some examples as a followon. MS. HOLAHAN: MR. CAMPER: MS. HOLAHAN: Or possibly 2C. Or possibly -The last line of 2C indicates procedures should specify situations when surgical interventions may be necessary -MR. CAMPER: MS. HOLAHAN: Yes, you're right. -- and the steps that should be taken in the event that surgical intervention is required. MR. CAMPER: For example, dah, dah, dah. 23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 you work. MR. QUILLEN: to take care of. MS. STITT: Any other comments on that section? Does that mean we're That's for doctors and physicists section. MS. STITT: You don't have any emergencies where MS. STITT: And you could certainly go back to some of the problems that have passed through our desks as cases that have actually occurred. make them up; they're there. Are there other comments on the emergency procedures section? MR. QUILLEN: I don't have any comments on this You don't even have to How did we get to the end of the paper? done? MS. HOLAHAN: MR. CAMPER: MS. HOLAHAN: MR. AYRES: No. No. Sorry. I was summarizing the changes and we of course hopped around in the various sections, and then the last one, Emergency Procedures, caught everyone's attention and we sort of dove into that one. MS. STITT: Of all the things that I looked through it was one that I think raises a lot of questions and becomes one of the very important ones. 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 not -MR. CAMPER: It's particularly problematic in the Well should we go back? MR. CAMPER: That's fine. When we get to the part where we talk about the presence of the authorized user and the physicist it would be interesting to get some thoughts from the committee members as to whether or not those are in fact -- that dual requirement is in fact a reasonable an appropriate requirement. There has been some comments of a negative nature about that. MS. STITT: Let me change text -MR. CAMPER: MR. AYRES: But not that many. I get an occasional call, but it's context of PDR, and the more criticism levied. MS. STITT: Yes, right. And maybe that's just a whole section to itself. Let me stop. fumbling around. We were at page 2, and kind of Let me just Everybody's been through this. go across the committee, and starting with Trisha. Of the things you were going to look at today, name the ones that are at the high point of your list that you want to make sure we hit. MS. HOLAHAN: MS. STITT: MS. HOLAHAN: Training. Probably PDR. Training, PDR. The emergency procedures, which 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 course. we've already addressed. Was there one more, Bob? There was one other one in here. MR. CAMPER: In your training comment, you're I'm trying to think. thinking about the physicists -MS. HOLAHAN: Yes. Physicists, the nurses, everybody that's involved. MS. STITT: And the QA/QC. Larry? In the whole document, Okay. what are the biggies for you? MR. CAMPER: Well emergency procedures, of And the question of the mandatory presence of the authorized user and the physicist, and whether or not that is overall considered to be a reasonable request, particularly as it relates to PDR. Similarly I have some thoughts and On the physicist in particular, concerns about the training. in the sense that what we have then, is we've taken the existing teletherapy physicist in the regulations and attempted to make it fit for the use of HDR. Now I think that ultimately the way to solve that is to do a better job in the regulations of defining a medical physicist and perhaps some categories of medical physicists, specific by modality. But just some thoughts as to whether or not that approach to the training for the physicist is appropriate and reasonable. MR. AYRES: And I don't think OGC is going to let us get away with anymore that there should be an authorized 26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 user, medical physicist present. MS. STITT: You mean the word "should" or what do you mean get away with anymore -MR. AYRES: Well they're not going to allow us to say we require them to be there because that requires rulemaking. MR. CAMPER: my big picture items. MS. STITT: fractionation. Okay. The one I had to add to is That's right. So anyway, those were That's a bugga boo that I've -- and others you've already named. How about you, Dr. Quillen? MR. QUILLEN: The medical physicist qualifications is the issue that I had at the top of my list. It's 8.5.l. MS. STITT: your list, Bob? MR. AYRES: MS. STITT: Yes. I just want to make sure. We spent Okay. And did we get everything on lots of time on these big issues, and if everything else is -there will probably be some rapid page turning, but -- Because this is not new to this group; we've discussed this since I've been a member of this committee. MS. HOLAHAN: little easier. Which is fine. It makes it a 27 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 page 2. a separate. MR. AYRES: In the comments I've received to date the only major technical -- the issue that was raised from the written comments has been by one state, thinking that the requirements on PDR should be a lot more restrictive than they are. MS. STITT: MR. AYRES: MS. STITT: MR. CAMPER: I wonder what state that is. Illinois. I was going to say -That's interesting. Well maybe when we get down to PDR it'll be kind of interesting to see what their thoughts were. MS. STITT: And I think we're going to do PDR as Is that all right? MR. CAMPER: MS. STITT: All right. However you like is fine with me. Try to break this down. I'm back on page 2 then, and I think that we just need to move through the things that seem to sit pretty well with people, and don't have to discuss each item. MR. CAMPER: MS. STITT: MR. QUILLEN: That makes sense to me. Radioactive material is Item 6. I have an item at the top of And it relates to the difference in the way states And that is, in the top operate and the NRC operates. paragraph, that you're saying you cannot comply with certain of your existing regulations therefore you're providing 28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 alternative language and license to cover those. In our particular state as an example, if you have a regulation you cannot through a guide, which is this type of a document, change that regulation unless that guide goes through a regulatory process. MS. HOLAHAN: MR. QUILLEN: Even through the exemption process? They would have to ask, and you would have to play the game, where they ask for the exemption and then you grant it to them, but you cannot change the regulation through a guide, which is basically -MR. AYRES: Well, we're not here either. What we're doing is we're providing the information that they should provide to ask for these exemptions. MR. QUILLEN: understand the -MR. AYRES: MR. QUILLEN: It's a fine point. -- the fine point you're doing I understand what you're saying. I here, but I'm just saying -MR. CAMPER: And what's happened here, Bob, And what's really is -- it's an excellent point you raise. happening here is sort of a backwards way of doing this whole process. I mean what we have here, we have an emerging technology that's emerged since the regulations were developed in '87, then in the midst of this emerging technology we have 29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it. MR. QUILLEN: You're going about it -- In our I'm a serious event of consequence, patient death, subsequently followed by an effort on our part to enhance guidance and to impose through either the exemption process or the imposition of conditions what we hope is a reasonable level of regulation for this modality, which has obviously significant radiological consequences, possible. But you're right, it's a strange way to go about particular state we could get challenged on doing it. just telling you that. MR. AYRES: Well, the advantage of this of course is, all of these standard licensed conditions as we call the, which are exemptions in lieu of. You go back and look on page 38, all the conditions are almost all in lieu of to change the requirements that can't be met in the existing regulations by remote afterloaders. In other words, you can't count the sources and that sort of thing. The advantage of doing this way is we go through and this is all pre-approved by particularly OGC, so we don't have to run every time a license comes in from one of these devices this doesn't have to go over to OGS for -- These exemptions can be granted by regions without coming into headquarters and getting them approved for every license every time, again and again. 30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: It's interesting again your comment, in the sense that, if I look at Part 35 today and I look at brachytherapy I see really two significant flaws in regulations. One is that, we need to do some adjustment with I mean, regards to 35.400, which is brachytherapy at large. the fact that we list specific sources for example as opposed to saying, for any use which has a sealed source and device registration on record. saying. In the second one of course is HDR. HDR is And that's what we really should be unique enough and the consequences of its use are serious enough that it warrants a separate subsection. MR. AYRES: afterloading. MR. CAMPER: That's right. Now we have a ruling Actually it's in the entire remote by OGC that HDR is captured under the 35.400, and we have tried to work to clarify then what we expect. But what we ultimately want to do is to make it explicit and clear in the regulations, put it through the due process and so forth. And we were going to go down a pathway -- We had made a decision at one point to pursue specific changes to Part 35 that dealt with brachytherapy only, and we were going to go through sort of -- if such a thing exists -- an expedited rulemaking to deal with these issues. But then a decision was subsequent made to do it all as part of the major 31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that up. revision to Part 35. Because, well you know we have the National Academy of Science report, and we want to take a look at that, bring that to bear. major effort. And so we're doing it all as one I mean not the But I agree with you totally. way I would prefer to do it, but given the technology and the possible consequences we had to do something. MR. QUILLEN: Well I understand what you're doing, but I'm just saying that presents a particular problem in our state. We have a statute which says, you can't make policy through this kind of a thing, you have to go through a regulatory process. MR. AYRES: Well, we do too in a sense, and so some of the language in there in fact has to be changed. Where there are some "shalls" or "musts" they have to be changed to -MS. HOLAHAN: MR. AYRES: MR. CAMPER: MR. QUILLEN: "Should". "Shoulds". That's right. That's what I was going to follow up on because there are shalls -MR. AYRES: MR. CAMPER: Yes, that's got to be fixed. And you're right, we have to clean We had We can't use "shall" in a guidance document. a couple of "shalls" I think yesterday and we were focusing upon "should". Excuse me, we didn't have "shall", we had 32 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 page 2. so. Do we need to do this line by line? MR. AYRES: I think that sort of thing has all "must" MR. AYRES: MR. CAMPER: MS. STITT: Some of that. You can't use "must" either. Is that stronger than shall? I think been well captured by OGC's comments. MS. STITT: Does Item 7 also relate to the discussion that we're having right now, "Purposes for Which Licensed Materials Will Be Used". Is this the same problem you have within the state, that other states may also have? Other comments on 6 or 7? MR. QUILLEN: There's a note at the bottom of I'm not sure whether it goes to the top of page 3, but I couldn't understand -MS. HOLAHAN: MR. QUILLEN: No, it's just separate. At the top of page 3 it just says, on my copy, "registration certificate for the device, and/or source, period." MS. HOLAHAN: MR. CAMPER: bottom of page 2. MS. HOLAHAN: MR. QUILLEN: Yes, that is part of the note. Okay. Is there a brachytherapy Oh, then that is part of the note. It follows on from the note on the 33 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 module registration certificate? MS. HOLAHAN: No. Where it says, RAL brachytherapy module, just that's the footnote at the bottom of each page. The note should be three lines and the last part of it goes from "as set forth in the registration certificates." MR. QUILLEN: MS. STITT: page 3 and page 4? MR. QUILLEN: two sentences -MR. AYRES: him, then I see it. Mine's been fixed. I couldn't follow On the bottom of page 4, the last Okay. I've misread it then. How about other comments you have on I have a copy where -You have the only correct copy. So you have the correct copy with The last two MR. CAMPER: MR. QUILLEN: the verbs in the sentences then, right? sentences need verbs. MS. STITT: sentences what? MR. QUILLEN: Say that again, the last two Well for example the last sentence says, "In addition the manufacturer's name, address and telephone number for each device requested." requested, are requested -MS. STITT: We have an incomplete sentence, It has to be is 34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 folks. MR. CAMPER: MR. AYRES: MR. QUILLEN: MS. HOLAHAN: MR. CAMPER: MR. QUILLEN: MR. AYRES: should "changed". MS. STITT: move to Item 7? MR. QUILLEN: MS. STITT: Sure. Okay. Item 7, "Purposes for Which Comments on Item 7? Are you ready to Okay. Where are you at? Right here. The last paragraph. The bottom of page 4, Bob.l This one here, the change is made. And that's actually "charged", it Licensed Material Will Be Used". You've got some copy there. Did anything come in from your associates that we need to talk about? MR. AYRES: Minor editorial, except the OGC is again querying the basis for allowing broader use of the sources. For example on page 5, Item 7, third sentence, it says, "One of the objectives listing in the 35.400 is to ensure the sealed source is used has undergone some appropriate safety review." What is this based on? It's not apparent in the language that the registry and so forth -- And down at the bottom they say, "The sealed source safety section concludes 35 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the registered sources which pass testing criteria for institutional use, could be used for intercavity or topical. And again, we'll have to wrestle some of these out. This appears to be a generic exemption, which is not permissible. We have in fact been doing this in current licensing practice, so there are some of these things that OGC is again balking on. MS. STITT: So is that something you have to deal with outside of the subcommittee issues. MR. QUILLEN: That was one of my questions, which When is more a challenge for you people than it is for me. you talk about intraoperative or non-human use, and in particular non-human use, you're getting into experimental procedures or animal procedures, and that certainly -- well it should be described in sufficient description detail. There's a very subtle way of saying, you've got a lot of things you need to tell us. MR. AYRES: Yes. And I have some comments on that -- about that from a couple of the comments sheet. One of the problems that comes up here and I was trying to address with this language, the sealed source and device of safety reviews, often separate but can be done together. In other words you can have a registration You can have a registration And then in some cases you have a certificate on the source. certificate on the device. 36 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 registration certificate on the combination of a source and device. There's three major HDR devices used in the United States currently, and there may be some more coming which is the Omnitron and it's successor, and the Nucletron and the Gammamed. Well the reviews have been done by multiple entities, agreement states and us. And the language in them Some of the on the use of the source varies all over. registrations state what the source can be used for, and others completely ignore it. So, to try to put some language in here that can be used in accordance with the limitations on the registration certificate doesn't work very well. tried to actually say what you could use them for. MR. CAMPER: Bob, I have two questions for you. I haven't looked at this for The last two And so I Help me out here with something. a long time. But I'm struck by a couple things. sentences of the first paragraph. MR. AYRES: MR. CAMPER: Which page? Of page, of item 7 on page 5. We say, if you intend to use a source for purposes other than specified in 35400, you should request and receive an exemption to the regulation prior to use. Now, they may also choose to go the route of having the source or device reviewed and approved. And I 37 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 believe the material that you submit is set forth in 32.210, is that correct? But, in reading this, it's not as clear to me that the reader would understand that you have an avenue available to you. If a manufacturer has chosen not to have the source or device reviewed and approved for a particular use, that the licensee can also submit the same kind of information, go through the same process that a manufacturer. MR. AYRES: If you look at the first paragraph, page 2, I refer them to the guide for Preparation of Application for Radiation Safety Evaluation Registration of Sealed Sources Containing -- which is what they would follow to do this. And there's an error there which I'll correct. refer to both guides as 10:11. MR. CAMPER: MR. AYRES: One's 10:10, one's 10:11. I Let me see, where were you? Item 6, first paragraph, on page 2. What I do is, I talk about the radiation safety evaluation and I cite the guidance for having that done. I could go back to the section that you're referring to and recite it. That's where the process for -MR. CAMPER: Oh, okay. Maybe what you might do right there is insert a sentence that would remind them of that. Because if they're reading that and they think, well I've got to go the exemption route, well that's not the only 38 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 exemption. MR. CAMPER: There would still be an exemption, way. Okay? Although, I guess that would ultimately result in an exemption too. MS. HOLAHAN: They'd still have to get an but it's a little bit different, I think, than we set forth. MR. AYRES: MR. CAMPER: Yes. Then, in the final sentence -- and Medical again - help me out with this, I just can't recall. broadscope licensees are not limited to the conditions that you specify in 35400. But even a broad can only use it, can they not, for a use that's been reviewed and approved? MR. AYRES: According to Steve, sealed source devices -- I didn't think this case -- I was trying to clarify that. My understanding is a broad can design their machine and not have to have it reviewed. MR. CAMPER: I've heard that too. MR. AYRES: Okay. I understand that and I think It would be interesting for me -That came up with intravascular about device review for these -MR. CAMPER: Well, it would be worthwhile to fully understand or revisit why it is that even a broadscope could do it absent that particular device or source being reviewed for such use. Clearly broad scope institutions have 39 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 area. MR. CAMPER: MS. STITT: That's interesting. Okay. either. a higher level of sophistication and can probably use these things safely. But it would be interesting to know the intricacies of the regulatory basis for that to occur. MR. AYRES: Yeah, I don't fully understand that Like one In fact I know there are some exceptions. broad scope licensee recently discontinued -- built their own HDR. And in fact it had a custom review, Howard. MS. STITT: MR. CAMPER: Howard University. That's interesting. I'm just I'm not saying that's not acceptable. saying I'm a little bit perplexed as I sit here remembering all the intricacies of just how that happens and what the regulatory mechanism is that allows it to happen. It's something that I would like to take a look at, at some point. MR. AYRES: Well, OGC has competence in this So, then, how are we doing on item 7? Did we go through the issues you had? MR. QUILLEN: apply for this. MR. AYRES: Yes. Well, I'm not sure we have. I Have you had any veterinary schools know Sealed Source and Devices got involved in the approval of what they call the pig wire which was a HDR source intended 40 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 for experimental use on the intravascular area with pigs. Whether we -- a number of veterinary licensees are very small. know. MS. HOLAHAN: Most of it's broadscopes that are Whether any of them are using ACR, I don't doing the veterinary work. MR. AYRES: wouldn't know about it. MS. STITT: be doing it. MR. QUILLEN: Well, it's not a medical That's probably the places that would A broadscope could be doing it and we broadscope, it's a university broadscope. MR. AYRES: MS. HOLAHAN: Yeah. Well, many of our broadscopes are university broadscope which would be broad research and broad medical. MR. QUILLEN: The reason I say this is because our veterinary school has their own linear accelerator and they do their own -MR. AYRES: Oh, yeah. We clearly have veterinary But I'm personally teletherapy installations. I know that. unaware of many veterinary applications of HDR by our licensees. MR. CAMPER: MS. HOLAHAN: Similarly, I'm unaware of any. Does CSU have one? 41 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. QUILLEN: CSU has a linear accelerator. So, I'm just assuming that the next thing they'll want -MS. STITT: The next step is HDR. Well, our vet school has our old cobalt unit. But if it's going to happen, If HDR is used at the it's going to happen in his state. vets, that's where it will start. Other issues on item 7? MR. QUILLEN: MS. STITT: MR. AYRES: MS. STITT: None here. Bob? No. Trish, no? Everybody's happy. Are we ready to move to item 8, authorized users? I'm getting a couple of shakes over there. Let's see, am I right. intense area of concern list? MS. HOLAHAN: Yes. Now let me -- what I wanted Is this part of our to say is there are some issues that are applicable to all of the modules that are being developed that have actually been moved up into the body of 10.8. So if you notice under authorized users, there is no physician authorized users, that is because that is dealt with in the body of reg 10.8. Because it is the regulations, per se. MR. CAMPER: Why don't you just expand on that a little bit, so that Bob and Judith would fully know how the staff is doing that. 42 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 then. licensing modules, is take out those items that are applicable to all modules. For example, who do you submit your license to? MS. HOLAHAN: Okay. As part of the overall Sort of effort we are revising what is currently 10.8. updating it now. At this point we haven't updated the appendices and I think that is something that we'll explore a little further. Then it will all be tied in and folded in to the business process re-engineering licensing manual. But what we have done with developing these Basically, training for authorized users, waste management, certain types of equipment are addressed up in the body. And that's why, in some ways, as you go through you may feel that there are things that are missing. might be missing from the module, but not up front. MS. STITT: Got it. So, at item 8 under They authorized users we're looking at physicists, authorized afterloading physicists and that's the substance for section 8. MR. AYRES: MS. STITT: Yeah, that's correct. Okeydoke. Let's jump into commentary The section that follows that is training which is another high-priority topic. Trish, you spent a lot of time on this. Why don't you summarize the issues that are your areas of concern and 43 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 getting. MR. AYRES: Not really very many. This is one of any feedback that you've gotten. MS. HOLAHAN: Okay. And maybe I'll let Bob address the physicists first and then I'll get into the nursing staff. MS. STITT: MS. HOLAHAN: comments that -MS. STITT: The comments that you've been Okay. Bob, do you want to focus on the those areas that I think we are certainly headed for in general with part 35, if we ever get there. I think the feeling from the committee and all the input I get, and of course, from some physics professional societies, of course, is that a medical physicist is a necessity for a brachytherapy program in general, but a high dose rate in particular. Obviously we agree with that position with relationship to the high dose rate program. The problem becomes, again, this regulatory -making it fit. We don't have a description for other than a So what we've done in this is tried to teletherapy physicist. expand on that a little bit and define what we mean by brachytherapy physicist. Without saying -- we'd be very happy to have you substitute brachytherapy experience for teletherapy experience, et cetera. 44 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 experience. MS. HOLAHAN: And that, again, if you recall, was one of the issues we discussed, should they have specific experience with HDR. Currently, the way the regulations are written for a teletherapy physicist, is they must have experience with a teletherapy unit and they must understand the teletherapy regulations. Well, again, as Bob says there is no regulatory basis for the brachytherapy physicist, but we feel that it's important that they have HDR experience. So if they've come in and said no, we haven't done teletherapy but we've done all this brachytherapy HDR work and we'd like to be licensed as a HDR physicist, then we are considering that as equivalent experience. MR. AYRES: And we conclude with the fact that we made need to bring some of these to the committee. MS. HOLAHAN: MS. STITT: Right. Well, you've used the phrase here, And one of the things that I've kind of groused about in the past was terms that were sort of made-up terms. Granted, teletherapy physicist has been in there for a while, but the physics community doesn't have specific licensure any more than the medical community does for a brachytherapy physician. certification. I mean that's not a board It's not even a certificate type of thing. But that's not to say that experience in 45 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 teletherapy or experience in brachytherapy can't be -- I think those are different sort of things. It may not sound that way but I think that the way that the community actually works, they are different. MS. HOLAHAN: MS. STITT: Yes. In the other issue -- and as you read through this, it's relatively mild mannered -- the issue of remote afterloading which is what this module is. When you move to high dose rate remote afterloading is really one of intensity, not only the source, but the involvement. I think probably some of the comments that you get Bob, have to do with communities where the physics support is by contract and somebody comes by and looks at your cesium stock and reviews your plans. And that's very different from being there on site when you're using a high dose rate source. I think that's really where the problems can really develop so far as administering therapy. the NRC address that. Can we, can We'll get to that when we get to the presence of authorized users. MR. AYRES: were trying to change. -- Was in fact one of the things we Because the practice was, in fact, in The physicist was a contract many licensees, continuing. physicist who dropped by occasionally and was not necessarily or often was no present during treatment. MS. STITT: Right. 46 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 feedback? MR. AYRES: Or even during the treatment planning, in some instances. MS. STITT: And that's probably an adequate mode When you change that of function, under some circumstances. remote afterloading from low dose rate to high dose rate, I don't think it is. MR. AYRES: MS. STITT: No. What are you getting from your How does the committee review this particular issue -- I guess we've sort of already moved on to the presence of the authorized user. MR. AYRES: Well, the only formal input we've got on this, of course, is from one of the physics professional societies who think part 35 should be changed to require medical physicists for all brachytherapy. MS. STITT: MR. AYRES: MS. STITT: to gain by this? MR. AYRES: But, in particular in remote For all brachytherapy? Yes. Gee, do you think they have anything afterloading in high dose. MS. STITT: I guess I've strayed. I've moved on before the a descriptive -MR. CAMPER: MS. STITT: I've got a couple To get us back on track here. 47 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: the physicist training. Let me just sensitize the committee members to a couple of things ourselves in today. about the dilemma that we find And again, this sort of gets back to what I had a couple of comments here on Bob pointed out, Bob Quillen pointed out earlier this morning. Kind of where we are and how we are approaching this thing. You know, we refer here in the guide to the training specified in 35.961. Well, if you go look at the training in 35.961, you'll find again, as in all of our training requirements, we've got the certification route and certain board certifications are identified. And then we have the so-called "or" pathway which is a degree of some type of academic training and some specified and specific experience. Well, there are two things that we need to do when we start the revision of part 35 to really tackle these issues. One is -- first of all 35.961 is teletherapy What we need to do is explore with the Should there be physicists only. medical physics community what we should do. a medical physicist identified in the regulations and in certain subparts that are identifying teletherapy physicists or brachytherapy physicists or whatever. But we can't solve that now, but must bear in mind for the future. The second thing really is that we accept certain certifications. For example, we accept certification from 48 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 true. the American Board of Radiology in therapeutic radiologic physics; Roentgen ray and gamma ray physics, x-ray and radium physics or radiological physics. Then the question that we will have to re-explore is are those board certifications addressing the question of brachytherapy, remote afterloading being required in training programs that often lead to studying for the certification examination For years, the agency has relied upon -- every time you see a board certification or regulation, the process that has been gone through historically is we have talked with the boards and determined what they are actually requiring of their residency certification programs, and then we ultimately bring that board certification to the advisory committee on the medical use of isotopes and they say, yes, this would seem to be adequate and you may list it in the regulations as being acceptable. Well, there's been some criticism in recent times about whether those boards are or are not requiring training that we think is appropriate. been mislead to some degree. And perhaps maybe we have even Or what we were once told as a commitment is in fact not going on today. And I'm not saying that's either true or not I'm just saying it is something that we will have to explore when we revise part 35 and see what board certifications really mean. 49 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 The other thing that comes to mind is, if I look at this training experience -- and this is just so you'll have a real world understanding of what we've run up against. go to the "or" pathway, it identifies certain masters or doctorate level degrees in physics, biophysics, radiological physics or health physics that has completed one year of full time training in therapeutic radiological physics and an additional year of full-time work experience under the supervision of a teletherapy physicist. Now, that poses a couple of problems for us. One You is that we get people who come in with degrees, for example, with backgrounds in engineering. But yet they have had work So then experience and training in the medical physics arena. the question becomes is that an equivalent academic preparation comparable to a degree or masters degree in health physics? And then the idea that if one looks as the regulations literally, why do I have to get one year of supervision under a teletherapy physicist? What if I've been working for one year under a brachytherapy physicist, particularly one dealing with HDR. apropos if you are trying to do HDR. But it is a problem with some of the existing regulatory language. So what we've tried to do then, having said all Now, obviously that's more 50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that, is on page 6, item 1, bring to bear the fact that we're looking for experience in HDR or PDR sources. But most of the time, we can work our way through it when we get these unusual outlyers. We were about to bring an engineer who wanted to do HDR brachytherapy but then we pressured that there wasn't enough experience and they withdrew the request. And he's getting more experience. MR. AYRES: MR. CAMPER: We're processing one now. I share that with the committee to kind of sensitize you to a couple of the problems that we see. I recognize that eventually we will have to do something about it in the regulations. But with those kinds of problems and issues in mind, does it seem that we have put forth the best possible effort at this time under 8.5.1, items 1, 2? pertinent HDR or PDR experience. MR. AYRES: Item 2 is a policy issue that Janet To capture raised and I don't know if it's been resolved. MS. HOLAHAN: MR. AYRES: Not yet. Apparently, it's in the old reg guide but it's not really in part 35 about whether we accept equivalency from NRC. MR. CAMPER: MS. STITT: We have not resolved that yet. Do the attorneys have something to say about that or is that not their area? 51 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 physicist. MS. HOLAHAN: And I think our interactions to sorry. definition. MR. AYRES: It's not a -- it's not provided for in the present part 35 is my understanding, as one of the acceptable certification methods. MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: MR. QUILLEN: It's listed as a -Licensee. licensee or user. Well, my comments include that -- you've defined particular issue, but they also because teletherapy physicist which you have in the existing regulations, now you've got a brachytherapy or medical physicist which is not in the existing regulations. MR. AYRES: MR. QUILLEN: Right. And not in this guide, either, as a So you've got two terms here that are undefined. MR. CAMPER: Those two terms being what, Bob, I'm Teletherapy physicist. MR. QUILLEN: Teletherapy physicist or medical date with the community have indicated that we should, to include the ACMUI, that we should go the direction of looking to have a broad medical physicist with specific, you know, requirements underneath, depending on what they're going to be doing. If it's other than board certification. MR. AYRES: If we actually formally include one 52 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 physicist? easier to -MR. AYRES: first sentence. MS. HOLAHAN: Except that the title calls it an That's what I used if you notice the think. MS. STITT: Right. Could we just use medical It may be terms. MS. HOLAHAN: MR. QUILLEN: Okay. Maybe use one, but not both. glossary? MR. QUILLEN: Yes, if you are going to use the or both of these revisions of part 35 they would clearly need to go into this definition part, 35.2 is it? MS. HOLAHAN: Right. Correct. So, are you suggesting that it should go into the Medical physicist is sufficient, I I think it leaves plenty of leeway. authorized RAL physicist and I think we're getting into confusing -MR. AYRES: I was making an attempt here, and of course one has to do the dance with OGC on this whole area. But making an attempt here to use medical physicist and then sub divide down below that. You want experience in the areas in which they're applying to do work, of course. MR. CAMPER: Yeah, I think medical physicist would be the more commonly accepted term. 53 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: understanding. MS. STITT: Right, it certainly is. And it means It is within the industry, is my you don't have to come up with definitions that are viewed as being artificial by the industry. MR. AYRES: It's a case here that I think the way that part 35 was structured, that teletherapy, being the older technology had the bad accidents first and got this area addressed in the detail that we're now -MR. QUILLEN: Can I ask a broader question here? The guide pertains to not just high dose brachytherapy or pulse dose rate brachytherapy. It also says it applies on page 1 to low dose rate and if you ever have it, a medium dose rate. If I read the guide, it says here, I could read it to say that if I have a low dose rate facility I wouldn't need a brachytherapy medical physicist's qualifications because they're not covered in this section. MR. AYRES: Right. It says for HDR and/or PDR. That's where we feel a physicist is essential at this point. We're not imposing it on LDR. MR. QUILLEN: MR. AYRES: which I agree with. That was intentionally? And it goes along with an argument And until we change part 35 if we wish to I think it is a very cognizant address it then, it's correct. 54 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 here. argument that if we impose any additional requirements beyond those that we really, really feel are necessary on low dose RAL, remote afterloading, we discriminate against an advantageous ALARA procedure as opposed to conventional remote afterloading brachytherapy. So, any additional requirement that we put on LDR just discriminates against that technology. Because the hazard level other than a mechanical failure, at least on dose rate-wise, is no different than conventional brachytherapy. MS. HOLAHAN: And we haven't been specific and we'll discuss that tomorrow in the manual in terms of the requirements for a physicist, except generally along with other medical support staff; a dosemetrist, etc. MR. AYRES: That's the way I've treated LDR in To try to not impose anything above and beyond what we Except those things impose upon conventional brachytherapy. that are appropriate because the quality controls on the device and that sort of thing. and sources and so forth. MR. QUILLEN: What if somebody came into you with And in lieu ofs for inventory an application that said my experience is in low dose rate remote afterloading technology and now I want to use high dose rate? MR. AYRES: MR. QUILLEN: You mean a physicist? Yes. 55 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MS. HOLAHAN: Who was not board certi -- who did not have any of the certifications in the regulations. MR. QUILLEN: It says in here that you don't have to provide that information, specifically. MR. CAMPER: MR. QUILLEN: MR. CAMPER: MR. QUILLEN: Where Bob? In 1. Now, for HDR they do. I know. But I said what if somebody has that kind of experience and comes in? MR. CAMPER: Well, if you go down to 1 though, it says include information on the individual's experience in the use of HDR, PDR, RAL, brachytherapy and use of dosimetry systems used to perform the calibration measurements of HDR. If someone came in with only LDR experience they would not be satisfying the criteria they were asking for in item 1. MR. AYRES: And there certainly does -- the calibration of the sources between LDR and HDR are substantially different. MS. STITT: What comments have you been getting? I mean this has been out for a while. MR. AYRES: the physicist. classes; Very, very little. Almost nothing on What we -- the comments generally come in two and they've been very small across the board. It started with process with bulletin which is 56 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 where most of this originated. And the comments have been from a few physicians like how dare you tell me I have to be there to take care of my patient. The physics side has been really quiet except the professional organizations and almost all medical physicists are -MS. STITT: MR. AYRES: in support of it. MS. STITT: MR. CAMPER: certification. MS. HOLAHAN: That's right. They would prefer What a surprise. Well, they tend to favor board Very supportive. All lined up right behind the other that we only had board certification. MR. CAMPER: board certification. MR. AYRES: The other general comments we heard But, again, we can't only rely on mostly from the committee were mostly from the economic side of this issue. MS. STITT: The other aspect of economics is when It becomes very expensive. you don't do it correctly. MS. HOLAHAN: MS. STITT: Very economically -So, I think this is not an issue -- well, I think this is an issue that many people would agree with and we're happy with the way it reads. 57 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 35.2. too. MR. CAMPER: No, authorized users is addressed in with here. MR. AYRES: Well, it replies to authorized users, take on. MS. HOLAHAN: I haven't had a chance to discuss point? MR. AYRES: I guess my personal position is here a little bit, if we require it, it sort of levels the economics a little bit. MS. STITT: MR. AYRES: How do you mean? That doesn't give an institution the option of not having a medical physicist and trying to compete with an institution that does in a more thorough manner with trained professionals. MR. CAMPER: MR. AYRES: MR. CAMPER: Bob, let me ask you a question. Yeah. Are we exploring with OGC at this Or Trish, have we been exploring this question of recognition of physicists named on a state license? MS. HOLAHAN: because she had -MR. AYRES: That was one that Janet was going to I need to follow that up with Janet Definition of authorized users in 35.2 points out that agreements state if your named on an agreement state license it's acceptable. 58 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: MR. CAMPER: Okay. Yes. If you go back and look at authorized users, then it goes on to say, identifies an authorized user on a permit issued by a commissioner agreement state specific license of broadscope is authorized to permit the use of byproduct material. users -But it doesn't say that for the teletherapy physicist, and of course it is silent on the term medical physicist or HDR physicist. MR. AYRES: MR. CAMPER: Right. That is interesting. I think from Identifies and authorizes an operating perspective I would like to see the agency be able to accept the physicists that have been reviewed and approved by an agreement state, but you're right. interesting policy. MR. AYRES: Well, Janet's position was to bring That is an it to your attention as a management issue. MR. CAMPER: (LAUGHTER) MS. STITT: Trish, I have a question. On the Well, it has my attention. physician, granted about physicists, but we've made some statements here about physicists being present. In 10.8 does it say physician as the authorized user or the authorized user 59 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 then. MS. HOLAHAN: MR. AYRES: It does. We're just -- I'm just completing the must be present for -- is there a corollary somewhere? MS. HOLAHAN: down within the guide. MS. STITT: MS. HOLAHAN: Okay, keep going. It's in item 10 in that we say that It says -- we address that further the authorized user must be physically present. MS. STITT: That does appear in this document second or third round on the bulletin where essentially we have all of our licensees committed to that authorized physicist user presence with perhaps some RSOs. MR. QUILLEN: subparagraph 1. I understand what you're saying here, but from experience I've had in looking at some applications, this is really kind of vague, what you're asking for here. If I could Let me interject something here on suggest some additional language between individuals and experience if you could put in specific experience? MR. AYRES: MR. CAMPER: yeah. Bob, in your situation, do you expect to see or ask for number of cases involved? MR. QUILLEN: Well, the one case we had to deal with was actually not in the area but in the gamma knife area. 60 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 records? MR. QUILLEN: It wasn't a falsification. It was MR. CAMPER: MR. QUILLEN: Right. At the time we had to deal with it In retrospect we there was no guidance for gamma knife. didn't do a very good job of it because the person involved claimed experience, which in latter viewpoint,we couldn't document. And that's why I was trying to tighten up some of the language you have here. MR. CAMPER: Was there a falsification of just, you talk about experience, yes, I was there. MR. CAMPER: MR. AYRES: apprentice-type system. MS. STITT: MR. AYRES: authorized user. MS. STITT: You got it. Isn't that what medicine is? Well, for both the physicist and the Oh, I see. I know of the gamma knife it's an Well, I have to put in a plug, not that this group's going to go out and sign up, but I think, as probably many of you are aware, that it's been many years in coming, but the American Brachytherapy Society has developed a school of brachytherapy and we're having our first school this December. 61 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 And the school of brachytherapy is a 14-module course that will be given over time. going to be able to do three modules. session. sites. This year we're only GYN is a whole day Half day of intraluminal specifically, lung, GI And then a half day of systemic isotopes, P32, strontium. And different physicians and physicists in the field have put together these teaching courses. the GYN course. My point is that we will have experience that folks can decide to take or not to take. Institutions can pay I'm running the $1,000.00 to attend the session and this may start showing up as the trail that you see on qualifications. We're actually, in the GYN section, doing four hours of lecture and then four hours of hands-on with phantoms where we can do insertions of applicators, perineal needle insertions and case discussions. So it's the first organized attempt that the medical community has been able to put together. It's really on-going education in brachytherapy, and it will be all forms of dose rates. It's exciting for me to be involved with because it is something I've been hoping to do for years. least gives some focus so that if you want to be a brachytherapy physicist, whether we call it that name or not, And at 62 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 physicists. MS. HOLAHAN: with the ABS meeting? MS. STITT: Yes. This year the meeting comes And then on It's being given in conjunction there at least is some formal education. MR. AYRES: Are these courses oriented toward the authorized user, the physicist or both? MS. STITT: Both. The course that I'm in charge of has myself for high dose GYN, Patty Eifel whose well known in low dose rate, Beth Erickson is known for her work in interstitial, and Bruce Thomadsen who is one of the physicists that was submitted. So, our goal is to track physicians and first and then the school is Monday and Tuesday. subsequent years, the annual meeting is going to be six months off. So that the school is going to be given every December and the meeting is actually going to be in the Spring. MS. HOLAHAN: MS. STITT: Oh, they're moving? Yeah, moving the meeting. But that means that folks can come, get training in brachytherapy in great detail. physics. And it will be a combination of medical and In fact Bert Speiser is putting on one of his emergency procedure sessions where you have an emergency and proceed. So, I think it's going to help the community a 63 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to say. MR. AYRES: The only question I have do we do comment. MR. CAMPER: one step further, Bob. MS. HOLAHAN: MR. CAMPER: Give examples. And I'm wondering if we should be I do too, and I would only take it great deal. MR. CAMPER: MS. STITT: MR. CAMPER: MS. STITT: MR. CAMPER: MS. STITT: MR. AYRES: That's good news. And we're here to help you. That's right, you are. Trying to make your life easier. We're all for that. On item 8, other comments there? I added the "specific". I liked that requesting the number or types of cases? MR. QUILLEN: This is the next thing I was going that for the teletherapy? MS. STITT: MR. AYRES: Do you have to? Under training and experience I think you sometimes get it on the certification. MR. CAMPER: Well, what the regulation says, and I'd really have to take a look at the teletherapy guide to give you an explicit answer. But on a regulatory basis what we're looking for is the academic course, one year full time 64 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 training in therapeutic radiologic physics, which is fairly explicit, and an additional year of full time work experience under the supervision of a teletherapy physicist that includes the tasks included in 35.59, 35.632, 35.634, 35.641, which all deal with evaluating the beam, the various checks and so forth. MR. AYRES: Well, having looked at some of these, that's a fairly typical thing to be put down going this route for an authorized user. teletherapy physicist. MS. HOLAHAN: The other thing is you are asking But I don't recall seeing it for the for the number of cases and types of uses does not address the quality control checks that they are required to do which is what the teletherapy, I think, is getting at. MR. AYRES: That tends to be more like the current one that we have pending that Torre has on the authorized physicist. MR. CAMPER: If you were to do it, your sentence -- what you do is you put a parenthetical "e.g." following brachytherapy where it says include information on the individual's specific experience on the use of HDR, PDR, RAL, brachytherapy. For example, numbers and types of cases. And then go on to say and the use of dosemetry systems because Trish, your point is well made, it's not just about the clinical involvement. That doesn't satisfy the idea 65 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 so. members? of knowing the dosemetry systems and so forth. MR. AYRES: Yeah, I've also got some comments on some of the other material that I might need to factor in here. It includes also, of course, what Trish already mentioned, experience in the QC procedures related to these devices. MR. CAMPER: What is the thought of the committee Or do Is there any value in getting that or not? you think just the insertion of the term "specific" before experience, is that enough? MS. STITT: think you can ask. I think specific certainly helps. I You don't have to say you must have x- many, but you could ask for a listing. Are physicists accustomed to that? certainly are. Physicians Essentially all board certification requires you to list the number of laparoscopies that you've done by patient identifier. MR. AYRES: I'm speculating, but I don't think Most of the applications I've seen for physicists don't tend to put that kind of information in. MR. CAMPER: MS. STITT: MR. CAMPER: See, what you had -Process rather than the case. If you were to do it, and I'm not necessarily advocating that we do do it, I think the term "specific" inserted is a very good suggestion. 66 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of part 35. MR. CAMPER: So, I think what I'm hearing, for But, what I'd like to think would ultimately happen, again, in rule space, is that we'll work with the physics community to define some appropriate levels of training. We'll revisit what we have for teletherapist, we'll talk about medical physicist and they'll help us in developing specific words for requirements. And that may or may not include some clear identification of cases. MR. AYRES: It's clearly worth exploring revision now, just the insertion of the word "specific" might be enough. MS. STITT: Well, and the other thing just to keep in the back of your mind is certainly, any brachytherapy but particularly high dose rate is really an episodic sort of thing, even involving the dosemetry and the QC sort of thing. So, if at some point of time, the listing of cases is important, rather than the teletherapy which goes on all the time, all the time, all the time, but brachytherapy is a scheduled event and it wouldn't be unreasonable to say, show me the number of cases and what they involved. But right now may not be the time. MR. AYRES: Yeah, I am aware that some high dose rate programs have very low treatment, a frequency of one of 67 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 effort. MS. HOLAHAN: So, they could come in and say two a month. MS. STITT: Oh, right. And that's the other reason you may want to be specific about that, because brachytherapy is less than 5 per cent of radiation oncology. Many places it is zero per cent because it is too expensive and too high risk. Even with low dose rate sources, not worth the they've done a year of experience but only have done six cases. MS. STITT: That's right. And that's why the teletherapy is so different than brachytherapy and I don't think it is unreasonable to hold brachytherapy to some different standards. MR. QUILLEN: We had a facility that lost their therapist, their oncologist and did contract work for about a year. And during that time the HDR unit just sat there; never was used. MR. CAMPER: Let me ask again. I think I'm hearing -- Judith, I think you're comments just now were a fairly compelling argument for asking for the number of cases. Because you are right; one year's experience might be two episodes. 68 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 available. MR. AYRES: important than types. I think of the two, numbers is more Now, that does raise a problem. types. MR. CAMPER: Or we could be even more specific. That would be even MS. STITT: Right. But you might have seen them from the back of the room with 23 people standing in front of you. So that's some of the other quality issues that this has brought up. But I don't think this is -- I'm not picking on physics at all. This is the same for physicians. It is also an area where you can be very quantitative about and -MR. CAMPER: Well, I think what I would suggest then, barring any strong objections, that we would insert say a parenthetical "e.g." following brachytherapy where we say number and type of cases actually involved with. MR. QUILLEN: MS. STITT: I think that's a very good idea. You could put list the number and List the number and types of cases. stronger. MS. STITT: Because that data is easily Because then, if you are the reviewer in the region and you look at this, the question then becomes, what is enough? MS. STITT: the time being? Right, aren't we avoiding that for 69 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 would do. work with. MR. AYRES: MS. STITT: MR. QUILLEN: Well, we are, yeah. I think we have to. At least it gives them something to Because when you come into the ACMUI, the ACMUI at least then knows if the person has done one case or a hundred cases. MR. CAMPER: Right. And I think that's what I At some point there will be notes inserted in here for the reviewers, under the SRP approach. And I think that's what we can tell them. If there some question as to whether or not there seems to be an adequate number of cases presented, and not specify a number, then refer that to the advisory committee. MS. STITT: I think that you can be a medical physicist or a radiation oncologist and you don't have to link other terms to that, i.e. brachytherapy physicist, et cetera. You can be a medical physicist with a list of procedures and it tells your colleagues, it tells your regulatory agency, it defines your practice. MR. CAMPER: MS. STITT: requiring this? MS. HOLAHAN: next question. Actually, that was going to be my So, I think it works together well. Okay. Back to the physicians. Are we Because I'd mentioned to you that it was up front, but it is very general in terms of just reciting the 70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 a lot. My understanding, one agreement state requires specific HDR experience for physicians. In particular, my experience. May. requirements in part 35. Now, in part 35 it does have specific, obviously, board certifications that you can be an authorized user. Also, there is an "or" category in the clinical experience for which you must have three years of supervised, clinical experience. Examining individuals, reviewing case histories to determine their suitability for brachytherapy treatment, selecting proper brachytherapy sources. But there is nothing specific as to having HDR And I know we did explore this with the ACMUI in And I think, at that time, it was a good idea to have the HDR experience. Should we bring back into this a specific section to focus on the experience required for an authorized user. And Bob, maybe you can address as to whether that has been considered. MR. AYRES: Well, I'm not sure we've discussed it understanding is that the emphasis is they at least want the physicians to understand that this treatment, in most cases, must be fractionated and cannot be given in one fraction. that's the state of New York. I haven't seen a copy of their requirements, but And 71 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 I have heard they have some specific requirements for authorized users in HDR above and beyond the normal certification requirements that we have. MS. STITT: I think I would be enraged if I were a physicist to see that you were putting some things in the statement about me but colleague the physician has a different standard. The way I understand it, we're not saying you must do x-number. We're just saying, list. Right. And I think that's very acceptable MR. CAMPER: MS. STITT: and gives a feel. MR. AYRES: Well, one controversial thing that I have heard more adverse comments about is further down in the training. We do require the physicians to be trained on the device on normal and emergency procedures along with the physicist. MS. STITT: MR. AYRES: MS. HOLAHAN: You're getting some heat about that? Yeah. So, I think from what I'm hearing, we should probably include a section in here on the authorized users. And if they are not board certified -- and again I think Larry has pointed out that this is one of the questions -- how do board certification programs address HDR? MR. AYRES: My understanding from earlier 72 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 information from Dr. Flynn is that they don't. MS. STITT: MR. AYRES: MS. STITT: MR. CAMPER: On HDR. It depends on the program. You can't be assured of it. No. We're headed for some sit-down specific discussions with the boards and so forth and so on, somewhere along the line as we revise part 35 and get an understanding of what they're doing and not doing. we can come together and make it work. For now, maybe what Trish is suggesting is the idea, here under authorized users, we would insert a section with physicians and we could draw their attention to the requirements and the regulations under 35.940. But, it probably would be worthwhile to make a comment or two in there where it talks about the 500 hour supervised work experience, it talks about emergency procedures, it talks about the three years of supervised clinical experience that we would expect a demonstration of experience with HDR specifically. MS. HOLAHAN: MR. CAMPER: MS. STITT: Or PDRs. Or PDRs. All radiation oncology residents have And see if to keep a list of all patients, no matter what kind of therapy is being used. Brachytherapy, teletherapy, so, physicians are accustomed to listing and I don't think it will be out of the 73 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 movement. here? MR. QUILLEN: MR. CAMPER: Yeah, I think so. Well, it is a fairly significant ordinary of what they've seen before. MS. HOLAHAN: MS. STITT: It shouldn't be a problem. It may be a problem, it's just not out of the ordinary for what's expected of them. MS. HOLAHAN: MR. CAMPER: MS. STITT: Okay. So, that approach seems reasonable? Are they talking us into something I think it's a reasonable one. MS. STITT: But it's a big difference in what we've said and making the statement that we, and when I say we I'm talking about NRC, requires x-number of cases. That's very different from saying, "list". MR. CAMPER: MS. HOLAHAN: MR. CAMPER: That's correct. And I don't think we're saying -We would be saying that we expect to see specific experience in HDR embodied within these broader guidelines of the numbers of years of clinical experience. opposed to saying that we expect, as you just said, x-number of cases. MR. AYRES: I thought I'd captured that to some As degree with the training requirements for authorized users. They receive eight hours training on the device. 74 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 looking at? MS. HOLAHAN: trouble finding that. MR. AYRES: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: Ah -The normal and emergency operation? Yes. That's actually, and that was Where is that? I was having MS. STITT: Now, is that in the section we're another question, it's under the section for training for the medical physics staff which doesn't include the authorized user. And I noticed that one of the comments that we received was that we should require the same training for the authorized user. MR. AYRES: this section. MS. HOLAHAN: MR. AYRES: users, physicists. MS. HOLAHAN: Oh, okay. You're right. Maybe we Where? The licensee authorizes physician Yeah, it says authorized users in need to modify that title the same we modified if for yesterday. MR. AYRES: Well, if we put in an extra one for We didn't have one for authorized authorized user under 851. users where we had the section for physicist, so I didn't have 75 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 training. well. You're right, it does say authorized user; maybe it just needs retitling. MR. AYRES: general title is -MS. HOLAHAN: The subsection you've got it under And I think Oh, the title looks okay to me. The a place to put it. MS. HOLAHAN: Yeah, but we don't want that in there because that's what training experience that they have to demonstrate to us. What this is is what annual and refresher So I think we just need to modify this section as says, "Training for Medical Physics Staff". yesterday in the discussion on radioactive drug therapy we changed the title of that section to "Training for Staff Directly Involved in Administration and Monitoring of Patients Undergoing Remote Afterloading Therapy". MR. AYRES: MS. HOLAHAN: MS. STITT: MS. HOLAHAN: Oh, okay. Right. Rather voluminous title. A much longer title. That's right. But I think the question was who is actually considered medical physics staff. MR. AYRES: MS. HOLAHAN: MR. CAMPER: Yeah. And so I think we can -Yeah, if you make it clear that they 76 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 else on -MR. AYRES: I have a real good comment that I good point. MS. HOLAHAN: MS. STITT: MS. HOLAHAN: Okay. Are we working item 9 then? Yeah. Does anybody have anything even. are involved in the administration or MR. AYRES: the monitoring of -- Well, we might need to move that one. Maybe move it over under -MS. HOLAHAN: Up front. MR. AYRES: under general training. MS. HOLAHAN: MR. CAMPER: Right. I'll have to look at that. It's a Normal and Emergency Operation of -Under the general title, perhaps, want to introduce from region three on nine on training and it deals with nurses training and other staff. I'll just present it for comments. "We suggest, in addition of a descriptive sentence to the text in either the nurses' training section or as a definition in the glossary to better emphasize that all care givers need appropriate training to participate in RAL therapy. Especially low dose rate and pulse dose rate. The new sentence reminds licensees and applicants that the term 'nurses' includes registered nurses, licensed 77 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 We suggest this because we have occasionally observed licensees who directly train only registered nurses or head nurses in brachytherapy therapy radiation safety procedures, while licensed practical nurses and nurses' aids actually render the bedside care for the patients. The trained nurses are then expected to train the bedside care giving nurses in a pyramid manner and this training style may not be as comprehensive or effective as the direct training provided by the qualified instructors." MS. HOLAHAN: I think that sets up the point that practical nurses, nurses aids and supervisor head nurses, any and all of whom may care for RAL patients and need the training specific in that module. Dr. Flynn has raised at several meetings in terms of the nurse training. And I just wanted to give as a lead-in to that, this list we had included in the module that was discussed at the last ACMUI meeting for the manual brachytherapy therapy and we did get comments back from Dr. Flynn. Now I think we have expanded or modified it and tried to address it to remote afterloading. I guess the question is, is everything included for remote afterloading that we would need for manual. 78 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: Well, I guess the short version is they want us to make it clear that training the head nurse or the RN is insufficient if they are using LPNs and nurses' aids to actually provide the hands-on care. We would expect them to receive the training first hand from the trainer. MS. STITT: Well, when you read through various appendices that the NRC staff sends out several times a year regarding low dose rate, be it manual or remote, it's commonly nursing staff or ancillary staff that's involved in a slipsource or an applicator that's on the floor. clear that the system is not working. So it's Or it's so diffuse that it's hard to get everyone trained at the same level. And the head nurse is not making rounds on these patients; she's making schedules. MR. AYRES: Right. I think this point is well taken, and I intend to incorporate it. MR. CAMPER: MS. HOLAHAN: receive direct -MR. AYRES: care whatsoever. MS. STITT: Caregiver is the term that was used. All nurses who provide any patient Yeah, that's right Basically, that all nurses should And that's kind of a catch phrase, but it describes that lots of care is given by lots of different named individuals. Well, we've got a lot on item 9 to slog through 79 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 training. here. Do you want to take a break? MR. CAMPER: MS. STITT: Yeah, 10 - 15 minutes. Yeah, we're a small group. We can rely upon ourselves to get back here in some orderly fashion. (Whereupon, the meeting recessed at 10:08 a.m.) CHAIRMAN STITT: Back on the record, then, and we left on Item 9 and we've been discussing training, so, let's jump back in. Is that where we left? MR. AYRES: Yes. We're on Item 9, yes. And, there's lots of pages of CHAIRMAN STITT: So -MS. HOLAHAN: Okay, I just want to, unless somebody has some comment specifically on the first 9.1.1, I just wanted to make a comment that came out of yesterday's -CHAIRMAN STITT: MS. HOLAHAN: Okay. Again, yesterday, they were Okay. talking about the radioactive drug therapy module and one of the recommendations was in terms of training for nursing staff to retitle that. And, again, that gets somewhat back at -- it's called training program for professional staff responsible for the care of patients undergoing H or remote afterloading therapy rather than specifically nursing staff. 80 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 CHAIRMAN STITT: comment you made -MS. HOLAHAN: And, I think they also wanted to I agree and it relates to the highlight the fact that the training should be commensurate with their duties because the comment was that there was a lot of detail training in here. And, there may be some nurses or caregivers that don't necessarily need the level of -- another comment, and I just wanted to outline what they had addressed in modifying these, because what many of the modules had very similar training programs in was the basic radiation biology. They felt it was more important that it was a basic radiation effects. That they didn't necessarily need to know radiation biology per se. MR. AYRES: You'll notice the second sentence in the first paragraph it says that individuals should be instructed in the following topics commensurate with their duties. MS. HOLAHAN: Yeah. They just wanted that bolded and underlined and I don't know what this subcommittee's thoughts are as to whether or not we should emphasize that or not. CHAIRMAN STITT: Well, in a clinical fashion I If you're talking about feel that that's exactly the issue. nursing staff there on the night shift with a patient with 81 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 sources in place, they don't necessarily need a lot of detail but they certainly need to know what applicators look like and isotopes look like and specific hands-on what do I do if this event occurs. And, this is a very awe inspiring list of general training topics. And, I like the idea of bolding the commensurate with their duties. And, again, you could also use examples if you wanted to do that. Not to be all inclusive but what should the caregiving staff that's making rounds on the patient what should they be looking for. That might get into too much detail. here's something. Number 18. Yeah, Dose to embryo/fetus limits. So, we'll Which people need to know what things. leave it up to the institution commensurate with the duties. MS. HOLAHAN: Yes, and I think, generally, in terms of the reg guide that is out on the instructions to prenatal workers, they also recommend that all, not all staff, but at least all supervisors and all female staff should receive that instruction before they actually become pregnant. CHAIRMAN STITT: MS. HOLAHAN: Um-hm. So, sort of up front. Right. And, I CHAIRMAN STITT: MS. HOLAHAN: So, there is guidance. think the other document actually referenced the Reg Guides' 82 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Sally? MR. AYRES: I don't think it should go. I think specific that could be used for some of these instructions. The only other comment that they made yesterday was they took out the last two items. 26. MR. QUILLEN: out the last item, too. MS. HOLAHAN: MR. QUILLEN: MS. HOLAHAN: MR. QUILLEN: The questions and answers? Yes. Okay. I wasn't sure how you instruct I was going to recommend you take What's here is 25 and somebody in questions and answers. CHAIRMAN STITT: The issue about previous incidents, why did they want that out? MS. HOLAHAN: Sally, do you want to address that? that's all from valuable lessons learned. CHAIRMAN STITT: MS. MERCHANT: I agree. That was one of the suggestions They did not want that it be changed to say lessons learned. that to be interpreted by some applicant slash licensee to mean that you had to provide your history to the -- in the training session even though it must be available. Legally, it must be available to the staff. That doesn't mean you have to stand up there and beat your breast 83 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and say we had incidents -CHAIRMAN STITT: Um-hm. MS. MERCHANT: -- and we were involved and -CHAIRMAN STITT: Or, you could take it to mean you have to have an incident before you can -MS. MERCHANT: -- they said does that mean that anyone who did not have any kind of incident, who had a perfectly clean record, should not have to address that point. In other words, it's a question of how's that going to be interpreted. MS. HOLAHAN: Okay. Because we weren't necessarily meaning it to be incidents at that facility. MR. AYRES: I've got a comment on that. Well, that came up. MS. MERCHANT: MR. AYRES: It's very good. That came up. So, the feeling was MS. MERCHANT: that most lecturers are going to use anecdotes. CHAIRMAN STITT: MS. MERCHANT: that would happen anyway. Right. And, that it would be something But, if it was going to stay in, they would have preferred it to say lessons learned rather than give anyone an impression, because keep in mind, as we had discussed earlier, it is guidance. These are not regulatory requirements and, unfortunately, people follow these as though they are gospel. 84 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. QUILLEN: Right. And, but the way this is phrased find. CHAIRMAN STITT: Well, the phrase examples can be very instructive and it doesn't imply that it's a previous incident. It could be an example from other incidents and, you know, that are in print or something you've just made up because folks learn best from example or -- what was the phrase you used? MS. MERCHANT: CHAIRMAN STITT: Anecdotes? Anecdotes. But, examples of circumstances or examples of situations. MR. AYRES: I have a comment here I'm trying to It addressed it very well. CHAIRMAN STITT: MS. HOLAHAN: Yes, Bob. Okay, the other point is, I mean, there is one information notice that's out in terms of some of these types of incidents and, you know, that would probably be made available anyway but not necessarily to new staff coming in. MR. QUILLEN: One of the things you want to get across here is the fact that there have been incidents. MS. HOLAHAN: of putting it in. Um-hm. I think that was the intent it could be interpreted as there was an incident at this 85 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 -CHAIRMAN STITT: How about something that says it to you. facility. MS. HOLAHAN: examples of situations? MR. AYRES: This one is very nice. Let me read So, examples of -- would you say It's a good comment. It says please confirm that for all workers and authorized users refresher training will include components that will serve to maintain an awareness of radiation safety with respect to changes in license, changes in regulatory requirements, and lessons learned, experiences derived from NRC information notices, NRC/NMSS newsletters, and NRC inspection findings at your own institution. MS. MERCHANT: I don't think they're required to give inspection findings from their own institution unless there's -- I mean it's got to be available. But, I don't think that they should have to interpret this as you have to include your inspection findings in your training. MR. AYRES: Well, this is a for example list but examples of clinical circumstances, clinical cases, clinical situations, any of those phrases? I mean a lot of times I will lecture and I just make up a case. 86 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 myself. MS. HOLAHAN: Examples of clinical situations. Combine several things that will CHAIRMAN STITT: make several -- the teaching points that you've been through. So -MS. HOLAHAN: lessons learned? CHAIRMAN STITT: MS. MERCHANT: CHAIRMAN STITT: this section on training. PDR devices. Well, I guess we -- if I ignore it for the time, where does that take us? MR. AYRES: MS. HOLAHAN: Is 9.1.1.2 for the PDR? Um-hm. Sounds good. Okay. Let's keep talking about Examples of clinical situations and Let's ignore, for the time being, Yes. No. No? Well -I had to reread it CHAIRMAN STITT: MR. AYRES: Okay. CHAIRMAN STITT: No. All right. The only reason I was trying to separate that out is PDR's got some issues that -MR. AYRES: What I tried to do here, and maybe not entirely successfully, this was a change from policy and guidance directive. Policy and guidance directive just, more or less, went down the topics serially and then had a license 87 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 here -MR. AYRES: -- it's tough to -CHAIRMAN STITT: MR. AYRES: -- I suspect that they are. successful. reviewer's guide that said this one applied to this and this one applied to that, a check list. This one, because it's more of an outline format, I tried to sub-index, LDR, HDR, and PDR, as appropriate and anything that didn't specify one or the other specifically was intended to apply to all. And, like I said, I may not be totally It's tough writing this for all of the remote afterloading modalities because they converge and a section will apply to all. Then, it will apply to a sub-set. come together again and apply to all. set has to be broken out because -CHAIRMAN STITT: those who have to use it? MR. AYRES: Well, that's what I'm saying -Because if we're confused at all Will this be understandable to Then, it will And, then, another sub- CHAIRMAN STITT: I think the intent is to provide -- is add a check list to this in the future? MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: For the license reviewers -Yes. -- there will be check list. But, 88 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 page 7. problem. to -Tell me your major sections. The major sections are what? MR. AYRES: It's easiest when you look at the Let me start from smaller. CHAIRMAN STITT: way that it's -- okay. the one's. But, again, I think it's more of a format Now that I understand how it's laid out it's easier Okay. So, it may just be the again, this will be going out to licensees and, I guess the question is is it confusing -- should PDR be dealt with at the bottom of the section on training? Should we go through possibly considering the training programs? CHAIRMAN STITT: I'm just -- as I look at the format -- I'm having format problems and maybe content problems. But, definitely, format. general training. On page 8, there's On page 11, there's general training. And, I'm not sure what they refer to. MR. AYRES: Well, that's because this is the nursing staff which we're changing to professionals responsible, on page 8 through 10. On 11, we start medical physics staff. It's I'm having trouble with the dots and 89 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 9.1.1. out. MR. AYRES: MS. HOLAHAN: Yes. So, if we took out that training index and where they're indented. MS. HOLAHAN: Actually, the first section we probably need the 9.1.1 because that's general under the training program and we can just start, then, the nursing staff as 9.1.1, I think. That may make -- at least get one set of numbers program for individuals responsible for remote afterloading the personnel should be instructed in, that first section is your general introduction. CHAIRMAN STITT: MS. HOLAHAN: Okay. I'm with you now. Okay. And, then, we -- CHAIRMAN STITT: MS. HOLAHAN: Then, the next section could be Take out one set of one's here. MR. AYRES: MS. HOLAHAN: Yes, just all the way through. Yeah. And, then, training for caregivers responsible, whatever the wording was that I coined before, then, under that training for caregivers, you'd have general training, normal and emergency operation, and, then, specific for PDR. Then, your next section would be 9.1.2. CHAIRMAN STITT: Which was medical physics? Is 90 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 understand. that right? MS. HOLAHAN: MR. AYRES: Right. Yes. Okay. I CHAIRMAN STITT: MR. AYRES: One general style comment here. got some comments on -- there's people -- and the cover letter didn't address it, I think, adequately, but these are not, as you've obviously noticed by now, sequential numbering. And, in the main items, as well as in the subitems, and that's because overall in the entire Reg Guide 10.8 they are sequential. But, the holes, like we go from Item -- under Item 9 we go from 9.1 to 9.3. 9.2 isn't there. That's something that doesn't apply in this module but is -- well, I'd have to have the whole outline for 10.8 to tell you why, what it is, and why it's missing. CHAIRMAN STITT: All right. I think I So, they should have, within each section, some similar format. MR. AYRES: Yeah. In other words, if you go to mobile diagnostic, Item 9 will be the same -MS. HOLAHAN: MR. AYRES: Right. -- it'll be training for individuals, but there will be other items that are in that are in that that are not in this one and vice versa. 91 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 say that. to -MR. CAMPER: No question. Well, I think the Reg Guide should But, what I'm thinking is I can MS. HOLAHAN: Right. Now, the question is does that get confusing going from the module back to the body back to the module is you are either a license applicant or a reviewer? MR. AYRES: If you have the entire Reg Guide 10.8 it shouldn't be nearly as confusing but -MR. CAMPER: Well, what's going to have to be -- I mean, obviously, the plan has been that the licensee can read the general stuff. They can go specifically to that module most applicable to them and the idea was that that would make it easier. Now, the point been made that you've got to go back and forth but have we've been as clear as we could be in the module that cross-referencing will have to occur? MS. HOLAHAN: MR. AYRES: MR. CAMPER: MR. AYRES: No. No. Well, maybe that's -I presume that would be taken care of in the Reg Guide, the first section. CHAIRMAN STITT: This is something that we need certainly see a scenario where someone who's trying to put 92 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 a module. MR. CAMPER: Well, yeah. But, is someone -together an application would go to this module. And, I think it needs to be in both places. MR. AYRES: doing this for sure. Well, I don't understand how we're I thought it was only going to be available as the entire Reg Guide. In other words, you couldn't write and ask us for You'd get the Reg Guide. It's a published, bound - well, eventually 10.8, the plan is that it would be revised. It would have all of these modules. If someone wanted 10.8, they would get the whole general text and they would get all the modules. MR. AYRES: MR. CAMPER: Yeah. But, if someone came in and said hey, send me the module on teletherapy, for example, they would get that and the general text of 10.8. They would not get all the modules. MR. AYRES: MR. CAMPER: That's what I didn't understand. But, here's the problem. I mean I can certainly see how a module, though, could become separated out in the field. CHAIRMAN STITT: MR. CAMPER: It will be. And, so, I think what It will be. we need to do is make sure that the main body of 10.8 draws 93 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 harping on. attention to specific modules. But, also, in the lead-in section of each module, remind them that they're going to need the main body of 10.8 and will have to cross-reference as they step through requirements outline in the module. CHAIRMAN STITT: It goes back to the thing I keep In the training section, there's nothing about physician training here because it is -MR. AYRES: There's nothing unique here. Okay. CHAIRMAN STITT: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: Well -Except we've now discussed that item. No, I think that in Item 9 is, and that was what the discussion we'd had earlier, what is currently on page 11 is 9.1.1.2. But, we could change -- with the renumbering it would become 9.1.2, okay? medical physics staff? CHAIRMAN STITT: MS. HOLAHAN: Um-hm. Where it says training for the Everything under there is also So, if we retitle that as applicable to the authorized users. training for staff directly involved in administration and monitoring of patients undergoing remote afterloading therapy, then, all that information is also applicable. And, even though an authorized user has specific 94 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to bold it. MR. CAMPER: Yeah. Commensurate with your training and experience to be listed as an authorized user, they must also received all this training. CHAIRMAN STITT: Right. I think that's -- you have a way of putting -- linking more together but it's more MS. HOLAHAN: will make sense. MR. CAMPER: And, the other thing, too. There's But, I think when you see it, it some words that go under the heading 9.1.1.1. MS. HOLAHAN: Well, we'll renumber that. MR. CAMPER: Training for everybody. But, that paragraph becomes, what is it? with -MS. HOLAHAN: It's training commensurate It is in here and we're just going responsibilities and so forth. MS. HOLAHAN: MR. CAMPER: Right. Obviously, a physician doesn't need to know a lot about basic radiation biology and so forth and so on. MS. HOLAHAN: MR. CAMPER: We hope they know that. Some of the other topics it would because they already have had that, obviously. MS. HOLAHAN: Right. 95 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 state. nursing? CHAIRMAN STITT: there're comments. Actually, I'm just asking if CHAIRMAN STITT: got the outline. me. MS. HOLAHAN: Yes. So, basically, the two All right. So, I think we've The structure there has cleared that up for sections would be one is caring for the patient either while - and the other one is actually an administering and caring. So -CHAIRMAN STITT: So, within those, are there comments about normal and emergency operations, the low dose rate device? That appears under the -- it appears at the bottom of page 9. We been through the previous section. Should that be -- are you saying MS. HOLAHAN: should that be repeated in the second section? CHAIRMAN STITT: MS. HOLAHAN: Uh -The one that's for training for Anybody have comments on the emergency operation section for the caregivers. Let's go ahead and jump in with PDR because this is the caregiver section. Do you have comments that have come in, Bob Ayres, regarding the PDR? MR. AYRES: Yeah, a lot. One from an agreement 96 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 CHAIRMAN STITT: or how does the staff feel? Do you want to jump into those Trish, how do you view this section as it reads currently? Is this a compromise? Is this workable? This really states some of the things that we've been through. At least, this discussion is pretty straightforward in outlining what the dilemma. MS. HOLAHAN: Yes, it's outlining the dilemma and I think it's addressing some of the proposals that we have had come in as an acceptable alternate. CHAIRMAN STITT: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: Um-hm. Is that correct, Bob? I'm sorry. This is taking into account the proposals that we have had in as an acceptable alternate for PDR. MR. AYRES: Right. It incorporates presentation on behalf on AAPM at the ACMUI as well as a site visit. MS. HOLAHAN: MR. AYRES: In the ACR proposal? And, the one licensee we did have for PDR and the site visit included discussions between NRC, the licensee and the manufacturer. All sitting together. The region representative, myself and Jeff Williamson and Steve Teague. CHAIRMAN STITT: So, then, are we happy with it 97 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 there. the way it is? what's going on. Ironically, it's probably the best way to do brachytherapy just from a biologic standpoint. But, it's It certainly represents a small fraction of probably the most difficult way to do it from a safety standpoint and patient safety. MR. AYRES: The comments I've gotten on this and, again, some of these are agreement state specific problems like you brought up and running into problems with state law, that sort of thing. MS. HOLAHAN: I'm getting a copy made of the state comments that you're looking at. MR. AYRES: Okay. One of them is that the module indicates that NRC will consider trained nursing staff to qualify as device operators. It's actually nursing staff and therapists. They go on to comment the department rules prohibit a non-certified individual from administering radiation to humans and it is not likely that nurses will qualify. Well, I think there's a little misunderstanding They're not doing an administration per se. They're watching -MR. QUILLEN: MR. AYRES: Monitoring. -- monitoring the administration which was, in fact, was prescribed and started by the 98 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 system. comment. MR. QUILLEN: operator does. CHAIRMAN STITT: MR. AYRES: Yes. Right. Carry out the orders. That's what my linear accelerator physician authorized user. So, I'm not sure about the validity of that In teletherapy, it's the -- the therapists all the time are even more so involved in the administration than is the case for HDR. They made another minor comment on the training where we -- the module indicates that both practical and written exams should be administered. And, they think we should require that copies of the exams and answer key with a specified minimum passing criteria be submitted as part of the license application. That's maybe -- I'm not sure if we wanted to get involved at that level of detail. Where they get into problems with the HDR, it does not adequately address the use of PDR's they say. The module indicates a more sophisticated alarm Sensors lack of constant surveillance. And, it says the alarm system is not defined. I think they have a misunderstanding there and we could probably discuss that a little bit. I need to rewrite that for a little better clarity based on the comments. 99 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 In doing electrical engineering work in the past, I took some liberties on understanding that obviously, not everyone caught. The section implies that what -- their main thrust is that the patient remains attached to the device during non-treatment times and they object to that. They say if you're going to leave the patient attached to the device, you have constant surveillance. Otherwise, you disconnect. And, that's certainly contrary to the philosophy in which these devices were developed to be operated. And, I'm not sure I go along with that. that's their central thrust. But, If the patient is connected to the device, you have constant surveillance. If the patient is not -- otherwise, disconnect the patient from the device. And, they go into various examples, too, like visitors and so forth. That's the real thrust. What the special alarm system is, and maybe I should just explain it up front as the wording doesn't do adequately. But, what we felt was, and this is being done in, I understand, Arizona, they have a facility where they have this type of alarms, is that if the machine fails, and the definition of failure would be that you have what I call a wire, well, and it really is, a logical "and", that requires 100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that if the device is not in the safe, the room monitor must be going. Okay? That is the function check and if that doesn't happen, the device is supposed to generate an error, retracts the source. In other words, it indicates that the room monitor, the prime alert, what have you, has failed. generates an error. Retracts the source. And, required operator It intervention to correct the problem before the source can be - treatment can be restarted. The real alarm condition, and in this case we specify an audible alarm because it's not under constant supervision and it may be 30 feet down the hall from the nurses' station, is if the device says the source is safe, retracted, and the room monitor is alarming, then, a significant non-silenceable audible alarm is generated until the problem is corrected. That's a special alarm system. We tie the radiation monitor into the interlock alarm system and in two ways to generate an alarm and to run a self-test, if you will, on its function. In other words, if the device says the source is out, the alarm better be going. If the device says the source is in, the alarm better not be going. 101 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 find it. doing that? MR. AYRES: MR. CAMPER: MR. QUILLEN: I have no knowledge. Is Colorado doing that? No. Who's actually doing PDR? None MR. CAMPER: MR. AYRES: MR. CAMPER: This is an Arizona requirement. Yes. Are any of the agreement states CHAIRMAN STITT: MR. AYRES: There's very few of them. anymore in our states and -MS. HOLAHAN: MR. AYRES: Is there one in Arizona? There is certainly one in Arizona. Who is it? Do you know? CHAIRMAN STITT: MR. AYRES: Who? CHAIRMAN STITT: MR. AYRES: What institution? I have a list. I could No, I don't. I could find that out. CHAIRMAN STITT: There can't be more than a couple of places that even do brachytherapy to any degree. MS. HOLAHAN: MR. AYRES: MR. CAMPER: MS. HOLAHAN: I know UCSF has a program. Yes, yes. They have one. Who does it? UCSF. San Francisco. And, then, I know there's some research on-going in Michigan. MR. AYRES: Yes. The philosophy applied to this 102 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 not equal? was recognizing that the level of risk was one tenth of HDR but substantially more than LDR. It's a 1 Curie source max. So, that -- translate that into that you have 10 times more response time than you would with a comparable accident with HDR with everything else being equal. MR. CAMPBELL: What about when everything else is Treatment duration is not equal. MR. AYRES: Well, the actual -It's several hours or days. MR. CAMPBELL: MR. AYRES: Well, it's 70 -- it's a typical LDR. Overall treatment period, the actual source exposure time, is comparable. In other words, the source may be out 5 minutes. And, everybody agrees that this is an experimental modality in that all the evidence suggests that you get the equivalent of LDR tissue response by pulsing the source. It depends on the source strength. If its a full 1 Curie, you may be treating 5 minutes of every hour. If it's a half a Curie, you have 10 minutes. If it's a quarter, you have 20 minutes of every hour until you reach source exchange. The advantages of it are is, of course, it apparently produces the identical tissue response to that of LDR. 103 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 wish. It allows nursing care without interfering with the treatment in any manner what so ever unless there's an emergency because the nursing care can be scheduled for the off time. Obviously, you could schedule visits, too, if you The one thing I've talked to to the people at Mallinckrodt that were using it, the other touted advantage of it, apparently, isn't, or at least at that institution and, as far as I know, not very much used, is the ability to shape the field by the stepping -- varying the dwell times. It would have, I guess, an advantage over conventional LDR. With a smaller source, you could probably treat some areas that might be more difficult to treat with a large manual afterloading. CHAIRMAN STITT: So, what do we need -- do we I mean I think have what we need here, for the time being? PDR is probably the most ethereal of all the things we're discussing because it's the least established due to all the pluses and minuses that you just elucidated. I think one of the issues that's bothersome to me and also to the NRC is that there may be a one tenth of the level of problem if a source is stuck in place. However, if you don't know that that source is stuck in place -MR. AYRES: Right. 104 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 treatment. MR. AYRES: MR. CAMPER: MS. HOLAHAN: MR. CAMPER: Yes. You've got a duration problem. Right. You have the question of There are some wit. MR. CAMPER: That's the point I was getting at. CHAIRMAN STITT: -- one tenth doesn't matter a You know, you have a monitoring problem -MS. HOLAHAN: MR. CAMPER: Yes. -- that you don't have with HDR availability of the right staff all the time. problems like that. MS. HOLAHAN: We've tried to get around that and we have gotten around it with HDR saying the authorized user and the medical physicist have to be present. MR. AYRES: What the components here are, besides the special alarm system, which is, if you will, in lieu of somebody sitting there watching there all the time. Maybe that's not adequate. The other one is that the people that do watch it or who are available to respond immediately, that is, within a minute or less. Well, we really don't specify that. But, they'd be specially trained in all the normal and emergency operations. 105 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 exam. They have to prove their competence by practical There's another stipulation in there that they need to be retrained twice a year because one makes the assumption that these individuals do not have the repetitive hands on experience that the physician and physicist does. You know, In other words, they'll be on shifts. And, there will be shifts that there'll be treatment going on and they won't be there and so forth. And, so, we put in a double the training refresher requirement and there is a requirement in here that the ROS/physicist/physician be available in, I'd have to look it up, in some minimum amount of time to respond to a page, be it home or wherever. And, now, whether this aggregate set of requirements is sufficient is what's on the table. CHAIRMAN STITT: Does the issue of emergency -- when we jumped into our discussions this morning, we actually starting talking about emergency -MS. HOLAHAN: Procedures. -- management of HDR sources. CHAIRMAN STITT: Where did I loose that section to? MS. HOLAHAN: That was around page 34 or 33. And, that is in which -- what is CHAIRMAN STITT: section 11.2 called? MS. HOLAHAN: Section 11 is called radiation 106 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 address. CHAIRMAN STITT: -- and contemplating PDR, this It doesn't have to safety program. CHAIRMAN STITT: Okay. So, then what we discussed as far as this section that we've discussed should also relate to PDR. Is that correct? MS. HOLAHAN: Yes. That is, as far as retrieving. Now, again, that raises a question of the surgical intervention, yes -CHAIRMAN STITT: at the document -MS. HOLAHAN: -- which we don't specifically Right. But, if you're looking emergencies procedures also relates to it. be repeated anywhere. MR. AYRES: Right. Okay. CHAIRMAN STITT: MS. HOLAHAN: MS. HOLAHAN: Right. All right, so, back to your Do we have what we need in question, which is the right one. this section for the time being? I guess just in general I think this is probably as good as we can do when you realize that this is not as highly developed, it may not be because of the constraints, but at least it makes some statements that we haven't made before. 107 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 people. up, sir. MR. QUILLEN: You have the new title of the And, later on, you use yet. CHAIRMAN STITT: You're not? You've got to speak CHAIRMAN STITT: MR. CAMPER: Okay. I suspect you're right. So, then, PDR was turned into CHAIRMAN STITT: something fairly easy. MR. AYRES: Well, we wrestled quite a bit and lots of discussions occurred between what's put down here and -CHAIRMAN STITT: That's why it looks so well done because you've done all the homework to set it up for us. Well, then, let's move on to -MR. QUILLEN: I'm not finished with that section, device monitor slash operator, okay? the title device operator. And, then, later on further, you use the title device monitor. one person. Then, I think you're talking about two different What are you talking about? CHAIRMAN STITT: Sounds like something that's out At first, I thought you were talking about of the nuclear reactor industry, doesn't it? MR. CAMPER: What's the second one? 108 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 there. MR. AYRES: PDR where we have those extra So, I did that with some operator. MR. QUILLEN: MR. HOLAHAN: On page 28, under 11 -Okay. That's referring to PDR find it. MR. HOLAHAN: We say device operator on 11, device monitor operator on page 10 and where -- do we say device monitor alone somewhere? MR. QUILLEN: Yes, back -- let's see. Let me It's on page 28 under 11. And certified. There we have a specially trained and certified device monitor. MR. AYRES: MR. QUILLEN: MR. AYRES: for that one. Where is that? 28. I think there may be a real reason Page 20? Let me get there and see. We have device operator up on 10. Okay. And we have -- where's your trained? Device operator slash -- monitor MR. CAMPER: MR. QUILLEN: MR. CAMPER: MR. QUILLEN: slash operator. operator. MR. CAMPER: The next page talks about the device Yeah, I have those two. Device requirements for the monitor. deliberation, but maybe it's not clear at that point. 109 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Bob? MR. AYRES: Well, because under PDR the nurses or MR. AYRES: PDR section. MS. HOLAHAN: Yeah. But, I guess we need to be Yeah, it is. They're both under the CHAIRMAN STITT: gizmo or a person? MR. AYRES: MS. HOLAHAN: Person. Is that the same as the device Is a certified device monitor a monitor operator that's referred to on page 10, I think, is the question, isn't it? Because it'd talk about only -- we have a primary device monitor operator -- consistent and decide what we want to call them. MR. AYRES: MR. QUILLEN: to call them. MR. AYRES: MR. CAMPER: And, maybe -- it looks like -Why is it just the device operator, Yeah, yeah. Be consistent on what you're going the specially trained nurses or therapists aren't operating the device. They're just -MR. CAMPER: MS. HOLAHAN: Right. They're more monitoring. So, could we take out operator on 110 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 intent. page 10, then, the slash operator? MR. AYRES: MS. HOLAHAN: Probably. I need to look at those. I mean for PDR, could it just be -For PDR, it could be a monitor I mean that's a possibility. and, then, the operator is the person who actually pushes the button. MR. QUILLEN: Because on the next page you have device operator which is somebody, it appears, that's under the physics staff. MR. AYRES: Yes, that's correct. That was the What we have for LDR and PDR, we have the people who watch over it are not the operators, not the ones who program it, not the ones who initiate the treatment. MR. CAMPER: A question for you, Bob. If I read 9.1.1.2.2 or 1 the list there it says an outline of initial training provided by the device manufacturer or individual, so forth and so on, the licensee gives to the authorized user physicists and/or RSO and device operators. What device operator is there that isn't an authorized user, a physicist, and/or an RSO? MS. HOLAHAN: MR. AYRES: MR. CAMPER: MS. HOLAHAN: MR. CAMPER: Therapist. Therapist. That's an authorized user. No, no. Oh, okay. A tech. 111 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 therapist. MR. AYRES: A lot of times, even with our MS. HOLAHAN: Formerly a technologist, now a requirements that the physicists and the authorized user be there, they are often there but actually somebody else, a therapist, is actually manipulating the device. MR. CAMPER: MS. HOLAHAN: Then, why don't you say therapist -Some states will only allow -- won't allow the physicist to operate it. MR. AYRES: It could be a dosimeterist. Does device operator get a CHAIRMAN STITT: definition somewhere? MR. AYRES: Is it supposed to? Well, that what I thinking about. With all these things we're talking about maybe these should go in the glossary. MS. HOLAHAN: MR. AYRES: Yeah, we could define it. Yeah. We'd get them straightened out and put them in the glossary. MR. CAMPER: Well, it's either that or you might See, an AU, a be a little more clear by saying or others. physicist or an RSO is a device operator, may be a device operator. MS. HOLAHAN: MR. CAMPER: Can be, yeah. Then, you can say or other device operators for example, technologists or dosimeterists. 112 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 physicist. MS. HOLAHAN: We've got that idea of the general category on the top of the page where basically -- right there. That's listing sort of who all the general folks are that we're talking about except there again -MR. CAMPER: Well, then, you ought to draw a distinction to device operator, then. MS. HOLAHAN: MR. CAMPER: Well -You see, once again you have a device operator as a line item. MR. AYRES: Well, I see something else here, too. I should delete and/or RSO because you made the decision towards the end to delete and/or RSO out of the required people and this is a place that I didn't -- I missed getting back -MS. HOLAHAN: Well, we could include RSO as Because -- possibly needing that though, as well, right? MR. AYRES: Well, the reason it was in there was because that was in lieu of the physicist if they didn't have one. And, I wouldn't think the RSO would need the training unless he was going to be a device operator or something like that. MR. CAMPER: And, now we require them to have the 113 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 somebody. MR. AYRES: And, then, we define in the glossary, MR. AYRES: MR. CAMPER: Yeah. You're right. That's a good catch. CHAIRMAN STITT: Well, I do like what Larry suggested in defining -- that the device operator has an explanation or an explanation just by that comma which could include a dosimeterist or RTT. MS. HOLAHAN: page, in the 9. -CHAIRMAN STITT: MS. HOLAHAN: At the top, yeah. Could we say, up at the top of that -- that that would include and that should actually be including authorized user, physicist, therapist, dosimeterist or other device operators, just in case. MR. AYRES: device operators. MS. HOLAHAN: Right. Just in case we missed I was just going to say or other put in the glossary, device operators and device monitors, and/or other device operators. MS. HOLAHAN: Bob, let me ask you a question. Up there is you've got the authorized user only for HDR and PDR treatments. Shouldn't the authorized user receive all that other general training, too? 114 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 CHAIRMAN STITT: MS. HOLAHAN: I thought it stated that it did. The way that it's worded is only the normal and emergency operation. MR. AYRES: Well, that wasn't my intent. That goes beyond, I think, what we need. Again, Dr. Stitt can very well address this but, I think, with LDR the authorized user is not necessarily even there when treatment is initiated. They may or may not be depending on the institution and the individual physician but requiring them to have training on the device, I think, would be clearly appropriate if they are the primary responder to a difficulty with the device. But, if they aren't -MS. HOLAHAN: Yes, but, if you look under the general training, it isn't really the -- well, the operating instructions, but it gets into the appropriate radiation surveys, the source inventory controls, source leak testing. Particularly, if others are all doing it under the supervision of the authorized user, I don't see, and let me ask -CHAIRMAN STITT: MS. HOLAHAN: Oh, I agree with that. -- Dr. Stitt, again, should that be included as part of the authorized user training as well? CHAIRMAN STITT: it should be. Yes. As far as I'm concerned, I mean, actually, this is all material -- this 115 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 would be training that if the authorized user is the physician, they would have been trained on during their residency or hopefully -MS. HOLAHAN: MR. CAMPER: one of those. control? MS. HOLAHAN: source is in the unit. What source is in storage and what Well, and then, don't forget, this Number 2. So, then, they may not need the -I do have a question, though, about What do we mean by source inventory encompasses remote afterloading or LDR as well. MR. CAMPER: LDR. Oh, yes. Yes. That's right. Okay. CHAIRMAN STITT: MR. CAMPER: MR. AYRES: That's it. You might say the Indiana, Pennsylvania had a poor inventory control on the source. MR. CAMPER: argue that point. MS. HOLAHAN: Actually, one of the conditions is Well, it's up to you but I might in lieu of the 35.406 which is the source inventory, so -MR. CAMPER: Well, I was thinking, obviously, of more classical inventory as in LDR. MR. AYRES: I forgot or didn't capture well what were we changing this title to 9.1.1 to which is going to become 9.1.2 which is train for medical physics staff? It was going to be training -- 116 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 comments? MR. QUILLEN: MR. AYRES: MR. QUILLEN: A couple editorial comments. Okay. On number 3, at the top of page 11. MS. HOLAHAN: Okay. I can give it -- well, training for professional staff responsible for the care of patients undergoing remote afterloading. And, then, 9.1.2 becomes training for staff directly involved in planning, administration and monitoring of patients undergoing. MR. CAMPER: yesterday, right? MS. HOLAHAN: MR. AYRES: MR. HOLAHAN: MR. CAMPER: Right. I may get together with you. Yeah. Yeah, you didn't have the benefit of If you had been there, it would That's consistent with our approach the discussion yesterday. have helped a lot but we can -MR. HOLAHAN: front of me. MR. CAMPER: -- get together on that. Bob Quillen, do have other Plus I have Sally right here in CHAIRMAN STITT: I think that should be a separate paragraph because the lead into that is how we're to act in this capacity as individuals who meet the following minimum training requirements and 3 is 117 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 page 11. MR. QUILLEN: editorial one. Yes. And, this is another It has almost 70 occurs. MR. QUILLEN: I'm next down to 9.1.1.2.2. CHAIRMAN STITT: The bottom of the paragraph on paragraph. MS. HOLAHAN: MR. AYRES: Oh, okay. There's a couple places where that not a training requirement. MS. HOLAHAN: MR. AYRES: Where? I'm sorry. Oh, I think I have a comment on that, Same thing, yeah. also, from another source. MR. CAMPER: MR. AYRES: It's number 3. It's not a sub-set. It's a separate You have a sentence here. words in it and the verb is the last word in the sentence. It would be helpful -MR. HOLAHAN: MR. QUILLEN: MR. CAMPER: In number 1? Yes. Our old English teachers would have found this intolerable, right? MR. QUILLEN: in front of the sentence. MR. HOLAHAN: We need to find on old English This is what's called a I would just put the verb up here teacher to fix that section, right? 118 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 doc. MR. CAMPER: MR. AYRES: MR. QUILLEN: Even a bureaucrat shouldn't do that. Sneak one in. That's all I have. All right. If we fix that on run on sentence. MR. AYRES: technical editor. Well, it hasn't gone through our I don't know whether this documents going to go through our tech editor. MS. HOLAHAN: manual will. CHAIRMAN STITT: period would help that out. MR. CAMPER: 70 words in a sentence. CHAIRMAN STITT: We can get that fixed for you, Yeah, that's right. We don't want I can see where a well-placed I don't know if the licensing CHAIRMAN STITT: page 11, that'll make him happy. How about page 12? It's still -- now, we're at normal and emergency operation at HGR remote afterloading devices. MS. HOLAHAN: I'm sorry. 12. Where are you? CHAIRMAN STITT: MS. HOLAHAN: Okay. Any comments on 12? CHAIRMAN STITT: MS. HOLAHAN: I'd like to make -- are we on the section for training for ancillary? 119 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 qualified. thought. MS. HOLAHAN: Okay. And, let's see if anybody else CHAIRMAN STITT: Let me just -- hang onto that CHAIRMAN STITT: has other comments that relate to normal and emergency operation of HGR remote afterloading devices, editorial or otherwise. MR. QUILLEN: On number 2, it wasn't clear to me what you were looking for with respect to affiliation. MR. AYRES: Well, often time, it's a vendor. Other times, it might be a consulting firm or in house. MR. QUILLEN: What you're really looking for is the qualifications, isn't it? MR. AYRES: MR. QUILLEN: MR. AYRES: Yeah. Rather than the affiliation? Well, yeah. Is there an advantage to knowing where they're from, I guess, is the question. MR. CAMPER: MR. AYRES: MR. CAMPER: What's the yardstick to judge? Yeah. I don't think there is one. It's really about their qualifications. MR. AYRES: MR. CAMPER: Yeah. Who. Who did it. And, are they I would I think Bob has got a good point there. suggest deleting the word affiliation unless somebody has a 120 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 down. compelling reason why we shouldn't. Yes. I guess the only advantage to affiliation of the vendor providing it, sometimes confer upon them expert status, maybe appropriately, maybe not. CHAIRMAN STITT: given an affiliation anyway. MEMBER QUILLEN: MR. AYRES: Yes. Yes. I would expect so, too. I suspect you're going to be I think you will be, too. It will be in their CV. Anything else that you want to Mr. MEMBER QUILLEN: CHAIRMAN STITT: discuss on normal and emergency operation, HDR devices? Ayres? MR. AYRES: I'm sorry? CHAIRMAN STITT: MR. AYRES: Anything else on that section? I don't have anything. I don't have anything either. All right. MEMBER QUILLEN: CHAIRMAN STITT: MR. AYRES: Not here. Dr. Holahan, do you want to move CHAIRMAN STITT: on to 9.1.1.3, "Training - Ancillary." DR. HOLAHAN: Which is now 9.1.3. Which is now. I'll get that CHAIRMAN STITT: "Training for Ancillary Personnel (Housekeeping, Do we have a new name for that Dietary services, Security)." section? 121 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 DR. HOLAHAN: No. No? Oh. CHAIRMAN STITT: DR. HOLAHAN: But I did want to address -- and because this went out later, I wasn't able to provide this to Bob yet -- that the other modules we have revised. Part 19.12 was revised this summer. And so it has now been that -- it used to be that anybody going into a restricted area need training. Now the revised language that we will revise this to read is, "Individuals whose assigned activities during normal and abnormal situations are likely to result in a dose in excess of 100 millirem must receive instruction commensurate with potential radiological health protection problems in the workplace." So basically if you've just got a visitor walking through, they don't necessarily need instructions or if you've got somebody who's just walking, an ancillary person just walking through, unless you feel they are likely a normal or abnormal situation. So that will be revised to read I think -CHAIRMAN STITT: DR. HOLAHAN: What you just read. -- the new language. Will that also include some CHAIRMAN STITT: examples like you just gave or are those sort of off the cuff? DR. HOLAHAN: going to be the same. I think the examples are still Particularly with HDR is that if 122 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 relate to? from? DR. HOLAHAN: Oh, this was out of the radioactive there's an abnormal situation, an individual if they are in a room with an HDR are likely to receive in excess of 100, so I think in many situations. Now, the point is -- and that's made at the bottom -- that "Licensees may choose to prohibit ancillary personnel from entering restricted areas." CHAIRMAN STITT: DR. HOLAHAN: provide some training. this sign is up." MR. CAMPER: And what document were you reading Okay. But they would still need to Basically "Don't go in this room when drug therapy module since we already made that change. MR. CAMPER: Okay. What do Number 1 and Number 2 CHAIRMAN STITT: I mean, I know what they are, but they're kind of Is this hanging out there, "Posting," and "Labeling." training they're supposed to have on posting and labeling or is there more information we need to hear? MR. AYRES: Posting -- "Individuals will be instructed in the following topics," and those are the two topics. CHAIRMAN STITT: MR. AYRES: should be moved. Okay. This parenthetical statement probably It gets a little bit in the way of 123 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 -MR. AYRES: "Radioactive material. Do not understanding that. It should be moved up ahead of that. Bob, help me out a minute. Yes. For ancillary personnel, Labeling is what? MR. CAMPER: MR. AYRES: MR. CAMPER: housekeeping, et cetera, posting is clear. Labeling on the device itself? MR. AYRES: Yes, for example. You can have the room posted or you can have -DR. HOLAHAN: You could have a label. I mean, if disturb" or something like that on a safe or -DR. HOLAHAN: Right. "Don't pick up something marked with a label on it that says 'Radioactive material.'" MR. CAMPER: Well, that's supportable here because we might have a lead container sitting around or a source that fell out. DR. HOLAHAN: MR. AYRES: MR. CAMPER: Right, source. Or a new source yet to be installed. Right. Okay. Just an editorial comment about the paragraph, though, a few lines up, where it says, "10 CFR 19.12." "10" can't stand alone at the end of the sentence, as in "10 CFR 19.12." MR. AYRES: MR. CAMPER: No. That -- Just a minor editorial comment. 124 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 comment. MR. CAMPER: The meaning of. The meaning of. There you go. with it. -MR. CAMPER: DR. HOLAHAN: MR. CAMPER: Yes. I'm sure it will. DR. HOLAHAN: It will be probably be moved anyway -- some when we revise it. I'm sure. One of the problems of the way MEMBER QUILLEN: this is stated is that what ancillary people need to be trained in is what is the meaning of labels -DR. HOLAHAN: Right. -- and signs. They don't do MEMBER QUILLEN: posting themselves. DR. HOLAHAN: No. Oh, okay. I guess that's the problem I had CHAIRMAN STITT: Thank you. When I see those two words there, in fact, I would suggest that we need a -- if you're going to keep that first paragraph, then let's make a second paragraph that says, "Individuals will be instructed in the following topics." It lists them. MR. AYRES: Yes. That sentence has got to be moved that follows that. CHAIRMAN STITT: Yes. But I agree with Bob's CHAIRMAN STITT: MR. CAMPER: Yes. 125 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 mean, okay. DR. HOLAHAN: And we could include that as well, but yes. DR. HOLAHAN: The other -- and, again, I don't But the CHAIRMAN STITT: Posting. The meaning of labeling, which I had to ask myself. MR. AYRES: Or you could put it in a sentence, "The meaning of the following topics" or "understanding of" or something like that. MR. CAMPER: MR. AYRES: Yes. It could be adjusted either place, mean to refer continually back to the other module. other point that was in there that raised a question as to whether or not it should be included as radiation protection to include concept of time, distance, and shielding. CHAIRMAN STITT: There you go. Concept of. I as opposed to meaning of posting and labeling and precautions. CHAIRMAN STITT: MR. CAMPER: Right, right. Similarly, I would be specific about You mean precautions when in what you mean by "precautions." rooms where remote brachytherapy is occurring; right? DR. HOLAHAN: into a PDR room with -MR. CAMPER: Right. I think we should be Right. It's even if they're going specific about what we mean by "precaution." 126 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 up. CHAIRMAN STITT: And, Trish, you keep bringing it We need to make these things as homogeneous as we can, where they should be, so that it doesn't appear that we're making up new issues under training just because the isotope may have changed or the use is changed. And where it makes It sounds like sense we have to, but we need some continuity. you're responsibility for bringing us up on that. MEMBER QUILLEN: One of the problems that you get into -- and I'll give you some experience to illustrate this -- is that when I was in Ohio, both the NRC and the State of Ohio had an ongoing set of issues with Western Reserve University and University Hospital. And when I asked the University Hospital what was the primary language of their ancillary staff, their janitorial staff, they said, "Polish." So they could not read instructions. I mean, they needed to be instructed in Polish basically what signs meant, what labels meant, what they were supposed to do. you couldn't post instructions in English on the wall and expect them to understand what they were supposed to do. MR. CAMPER: Yes. So you might modify your But sentence, then, where it says "Individuals will be instructed in the following topics," "in a manner that ensures that they understand the subject matter," something to that effect. MEMBER QUILLEN: That's right. You need to get something across that these people have to understand these 127 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 problem. the signs. CHAIRMAN STITT: in some tasteful fashion. MEMBER QUILLEN: CHAIRMAN STITT: What's posting? DR. HOLAHAN: Well put. Well, I was having the same And what's labeling? So if we say "meaning of posting And we do need to address that issues, rather than just be able to -MR. CAMPER: If you say something like what I just said, I think you're making the point without that treading on thin ice in that you begin to sound discriminatory. MEMBER QUILLEN: area it's Hispanics. DR. HOLAHAN: I know. I was down in Texas. And That's right. And I know in our many of the signs were posted in both English and Spanish. MEMBER QUILLEN: Right, but this is one of the You had things I noticed at University Hospital in Cleveland. many ancillary people who just didn't know. did what they were told, and that was it -MR. CAMPER: Right. I mean, they just MEMBER QUILLEN: -- because they couldn't read and labeling" and then "necessary precautions," would that be -MR. CAMPER: Well, again, I think the point that 128 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 I was making was it's necessary precautions when and areas where LDR or PDR or HDR is occurring. DR. HOLAHAN: MR. CAMPER: I mean, that's -- When in a restricted area? Well, see, you could be in a restricted area for some reason other than where LDR, HDR, or PDR is going on. I mean, the bottom line is you want them to know when they're going in a room where -DR. HOLAHAN: this is commensurate. MR. CAMPER: descript enough. MEMBER QUILLEN: DR. HOLAHAN: You know, this is too -But the language is going Yes. But, again, if we're saying Okay. Well, "precautions" is not nearly Right. -- that is currently in Part 19 says -CHAIRMAN STITT: It depends on what kind of precautions you're concerned about. DR. HOLAHAN: Well, it says "commensurate with potential radiological health protection problems present in the workplace" in Part 19 now. that to some degree. MEMBER QUILLEN: Well, the other issue I have is So I think that will address the situation we see periodically and I think other people see periodically is that janitorial staff does not follow the work rules associated with working in a medical environment. get bags mixed up. They So they put yellow bags up in magenta bags 129 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 too. and vice versa and white bags. And so there's an issue here that they understand whatever the -- not just the precautions, but the -- I hate to use the word "work rules," but something like that associated with the environment. DR. HOLAHAN: Well, would it be typical for many of the remote afterloading cases that ancillary staff would just be told not to go into the room? CHAIRMAN STITT: of what you're describing. MR. AYRES: And there isn't really a bag problem Yes, that's very typical because with remote afterloading. DR. HOLAHAN: MR. AYRES: associated with it. MEMBER QUILLEN: that that's what happens. MR. AYRES: I understand your point and -I don't know how many times in I know. But I'm just saying No. There isn't radioactive waste MEMBER QUILLEN: my life I've had to deal with that issue of putting -CHAIRMAN STITT: Why don't you take the I parentheses out of "Licensees may choose to prohibit"? mean, I only say that in a -DR. HOLAHAN: That could actually be moved up, 130 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 nurses. to what? DR. HOLAHAN: MR. AYRES: Anybody. Anybody, including physicists, CHAIRMAN STITT: MR. AYRES: It sounds like -That sentence needs That's in error. to be made a separate sentence that starts ahead of "Individuals." Yes. That one I've already noted. Okay. It makes it sound like CHAIRMAN STITT: "Oh, by the way" when, actually, a lot of people choose that route because -MR. AYRES: That will be made a stand-alone sentence between "review" and "Individuals." CHAIRMAN STITT: Good. And we're going to try to flesh out "Posting/Labeling," "Precautions" to include the things that we just brought up, then. "Training for Contractors." "Contractors" refer It just says everything that applies to your own people applies to contractors. CHAIRMAN STITT: MR. CAMPER: Okay. Wy don't you just -Give examples. CHAIRMAN STITT: MR. CAMPER: -- embody that term or that concept earlier when you're talking about who's being trained? DR. HOLAHAN: MR. CAMPER: Because -Why do you need a separate section? 131 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it could -CHAIRMAN STITT: DR. HOLAHAN: MR. AYRES: Well, give some examples. DR. HOLAHAN: Because we felt it was significant We didn't want it lost in the enough to bring it to light. body as you're just sort of scanning through to have contractors -CHAIRMAN STITT: DR. HOLAHAN: I can see that. We wanted to make sure that people were aware that contractors working for the licensee are still working on that license. CHAIRMAN STITT: Would you describe who And that will just catch contractors might potentially be? people's eyes. be sure. DR. HOLAHAN: Okay. We all know it, but I had to ask a question to I mean, in our -- CHAIRMAN STITT: involved in this. But, nonetheless -MR. AYRES: Contract nursing staff are And I think it's a potential risky area. It covers a huge spectrum. I mean, Give some examples. It could even be construction folks become ancillary personnel at that point. CHAIRMAN STITT: Well, somebody might say, "Yes. That involves the contract that we have for physics," but not realize that in some hospitals the folks who are writing the 132 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 users. CHAIRMAN STITT: MR. CAMPER: True. means you." MR. AYRES: Yes. We have visiting authorized license may not realize that nursing staff, particularly on certain shifts, are all contractual and are brought in from outside agencies for short. MR. AYRES: Yes. That's always a problem with overlooking particularly contract nursing personnel. MR. CAMPER: physicist, too; correct? MR. AYRES: Oh, sure. I mentioned that. You could have a consultant CHAIRMAN STITT: MEMBER QUILLEN: DR. HOLAHAN: Some examples. Operator, slash operator. I think you do have temp So if you brought in a -Some examples would say "This Yes. services for therapist, too. CHAIRMAN STITT: No longer. No longer? CHAIRMAN STITT: MR. CAMPER: The term authorized -CHAIRMAN STITT: MR. CAMPER: Not after the radiopharmacy rule. They can come in? Visiting authorized user no longer exists in our regulations after the radiopharmacy rule, which became effective in January. Remember that now they may, the 133 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 correct. under that? licensees may, authorize an authorized user provided they have certain board certifications and then subsequently notify us within 30 days of having done so. DR. HOLAHAN: So the term -- So locum tenants would be included Locum tenants would be included that they would just let us know if they are coming in? MR. CAMPER: As long as they're Board-certified. Now, if they're not Board-certified, they still have to seek an amendment. But you will not find the term "visiting authorized user" in the regulations today. MR. CAMPER: Oh, okay. Off track. CHAIRMAN STITT: the mobile HDR units? So that doesn't really relate to Those aren't visiting authorized users. Those are authorized users. MR. CAMPER: That's correct. MR. AYRES: in here whatsoever. CHAIRMAN STITT: That was meant to be off -- not We've had enough difficulties. Which, by the way, mobile HDR is not That's right. They're a use. off the record, but -- right. MR. AYRES: the cover letter. It was in the -- I guess it wasn't in The reason is we have yet to receive an application for mobile HDR. MR. CAMPER: Two reasons, actually. That is We have not yet received, although we anticipate 134 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 correct. receiving in the near future. prohibits -MR. AYRES: MR. CAMPER: Yes. -- licensing of a mobile HDR. If we But literally today Part 35 were going to license one, we would have to grant it by exemption -MR. AYRES: MR. CAMPER: That's correct. -- to Part 35. Now, as Bob said, we've never had to do that yet. We did meet with an organization this summer that was going to submit an application. They have not as of yet. The State of California has a license to mobile HDR; in fact, to this very same organization. MR. AYRES: Yes. And I understand they're We've been getting a actively advertising at this point. bunch of telephone inquiries in the last couple of weeks about mobile HDR from agreement states, in particular, but also some of our regions. I understand that also applies -- since it's not authorized, that applies to reciprocity also at this point. CHAIRMAN STITT: Have there been any misadventures from the California unit yet? MR. AYRES: MR. CAMPER: One misadministration. Your comment about reciprocity is One-fifty states that we will recognize under 135 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 records. CHAIRMAN STITT: MR. AYRES: Training records. All right. jargon? CHAIRMAN STITT: have for lunch. MR. AYRES: licensed mobile HDR. reciprocity. CHAIRMAN STITT: subcommittee meeting. MR. CAMPER: Yes, it will. "Records," 9.3. That will be a separate In other words, right now we have no And we would not grant it under I was thinking what I wanted to reciprocity those things which the agreement states have authorized their licensee to do unless it is contrary to our regulations, -MR. AYRES: MR. CAMPER: That's right. MR. CAMPER: Are we losing you in that regulatory Which it currently is. -- which it currently would be. CHAIRMAN STITT: DR. HOLAHAN: It just says you have to keep them. What? CHAIRMAN STITT: DR. HOLAHAN: MR. AYRES: It just says you have to keep them. For three years on your training That's under 9. Right. So it's training. CHAIRMAN STITT: Item 10, "Facilities and 136 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 thereafter? DR. HOLAHAN: Yes. 10.1 is general. Then you've Equipment." So 10.1 is really what it looks like? DR. HOLAHAN: Yes. Okay. How about 10.1.1 and CHAIRMAN STITT: got either the pulsed or then 10.1.2 is the low-dose rate, which is why it's broken down like that. CHAIRMAN STITT: MR. AYRES: Yes. Okay. We treat pulsed, medium, and And there are no high the same as far as shielding goes. mediums. And for biological response reasons, I would not anticipate any. CHAIRMAN STITT: Are there any comments that you've received about these sections? MR. AYRES: Not any -- again, across all sections There was something about are minor editorial corrections. monitors. I'm trying to remember. CHAIRMAN STITT: In the "Monitor" section, are we It looks like we are. trying to be inclusive of pulse? MR. AYRES: Well, this is the room monitor. Without having had a chance to collate these, if you will, it will be a little tougher. CHAIRMAN STITT: MR. AYRES: Under -The comment was Oh, I remember. relating to training and that we needed to explicitly address 137 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 circle. MR. CAMPER: We physicists say you have to keep You've got to watch those guys. or is it -MEMBER QUILLEN: CHAIRMAN STITT: No. It's fairly straightforward. the use of surveys meters and room monitors and interpretation thereof under "Training." I knew there was one comment in about that, having it in the wrong section. CHAIRMAN STITT: There is a separate section, 116, regarding pulse, dose, rate, and devices and more sophisticated alarm system. Bob Quillen, do you have comments in this section Nobody has -- it probably doesn't have changes in it, in particular, does it, from other past versions or -MR. AYRES: Yes. It's 10.1.1.4.2 on Page 16 I'm Most people going to have to just clarify a little bit. didn't understand why I "anded" and why I "orred." MEMBER QUILLEN: MR. AYRES: Neither did I. That's logical "and," logical "or." Like I said, my electrical engineering background came through there and got everybody. DR. HOLAHAN: non-engineers. MR. AYRES: I can draw a little integrated Logical to you, Bob, but not to the an eye on those engineers. 138 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 know. or "or." CHAIRMAN STITT: MR. CAMPER: DR. HOLAHAN: I recall this. That would help a lot. No. We understand what you're saying, Bob. MR. AYRES: I could do "this," instead of "and" Surrogate symbols. Let me ask, Bob, because I think I Do we specifically address that we will not allow portable shields for HDR; correct? MR. CAMPER: That's correct. Where is that? Because that's CHAIRMAN STITT: one of the things I was looking for. MR. AYRES: Yes. Is that in this section? It certainly is. That's why I was looking -- CHAIRMAN STITT: MR. AYRES: Now you're asking me to find it. Oh, "Adequacy of Shielding for CHAIRMAN STITT: HDR Devices," I guess. DR. HOLAHAN: diagram, I think. MR. CAMPER: MR. CAMPER: I'm on 19. It should be under the facility The facility diagram. No. Wait a minute. "For the PDR CHAIRMAN STITT: licensees specify." it. MR. AYRES: explicitly allowed. Well, we all feel that way if we can find Low dose rate. "Low-dose rate I And that's on Page 10. 139 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 shield. CHAIRMAN STITT: Then we need to add it. DR. HOLAHAN: MR. AYRES: Ten? Or Page 18, second paragraph down. Adequacy of That's portable or allows it for low-dose rate. Shielding for HDR." DR. HOLAHAN: I guess because the question has been raised about whether or not it should be allowed for PDR, I think. MR. CAMPER: DR. HOLAHAN: MR. CAMPER: request on that. DR. HOLAHAN: MR. AYRES: For PDR? Not for PDR. For HDR. And we're It has been raised. Yes. We have had a technical assistant's treating PDR the same as HDR. MR. CAMPER: DR. HOLAHAN: Right. Here we have on Page 20 in terms of for PDR afterloading devices, the licensee should specify the configuration of portable shields, if applicable." Item Number 2. But that PDR doesn't address -But do you know what? I don't think That's MR. CAMPER: we say under this category entitled "Adequacy of" -DR. HOLAHAN: MR. CAMPER: Right, that they cannot. -- that you can't use a portable 140 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 second -MR. AYRES: Well, I could try to just put it as enough. MR. CAMPER: Maybe I'm recalling the technical MR. CAMPER: Yes, we do. I could have sworn we addressed that someplace. CHAIRMAN STITT: We certainly talked about it assistance response in which we said you couldn't use it for HDR. MR. AYRES: said, "For PDR" -DR. HOLAHAN: MR. AYRES: Yes. -- "afterloading devices, the Oh, I did lie. Under 2 on Page 20, I licensee should specify the configuration of portable shields." MR. CAMPER: we haven't -CHAIRMAN STITT: Well, that might be a place to You covered LDR and PDR well. But stick the next number in there and -DR. HOLAHAN: Put it in that same paragraph? -- exclude it from HDR as a CHAIRMAN STITT: separate number, I would think. DR. HOLAHAN: If that's the case, then that an additional sentence in 2 that portable shields are not allowed in a little -- 141 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it? about it? MR. AYRES: MR. CAMPER: We just don't. Well, we had had one. We had one DR. HOLAHAN: Do you think it's significant enough that it should be called out separately as a separate line item? CHAIRMAN STITT: How often do you get questions technical assistance request that I recall. one? MR. AYRES: did the TAR on. Is that the only Well, we have had one, yes, which we And then I think there's been a couple since that I just referred the regions to the TAR. CHAIRMAN STITT: I'd make it a separate number, just make it a single -- you know, if it just needs one or maybe two sentences, but it would be very easy to see as you're running through this. MR. AYRES: Okay. It's something our license reviewers are very much attuned to. MR. CAMPER: Correct, but if someone were coming into the world of HDR new as a business venture or whatever, it would be good to know that you can't. CHAIRMAN STITT: look for it. DR. HOLAHAN: That would be HDR and MDR, wouldn't Right. You don't have to even Would it be HDR and MDR? 142 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that. -MR. CAMPER: MR. AYRES: MR. CAMPER: MR. AYRES: Oh, they are using? Oh, yes. Portable? Yes. That -Portable shielding? allow it. MR. AYRES: that's on the table. MR. CAMPER: the source strength. MR. AYRES: DR. HOLAHAN: Yes. I think, too, with PDR it would be Would it Well, you have, what, one-tenth of Well, I put that in there. I guess MR. AYRES: DR. HOLAHAN: Yes. For shielding purposes, yes. But just for PDR, we would Okay. looking at going into where it would be conducted. be necessary to have portable shields or it wouldn't -MR. AYRES: Well, they clearly -- most of the institutions I'm aware of tend to use PDR a lot like they use LDR. MR. CAMPER: MR. AYRES: Absent shielding. Well, except with shielding LDR for That one-curie source mandates They can't meet the unrestricted area under restricted area limits otherwise unless they don't use adjacent rooms or restrict -MR. CAMPER: You mean at the boundary of the -- 143 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it depends on how big the room is. MR. AYRES: the normal situation -MR. CAMPER: two mr per hour? MR. AYRES: MR. CAMPER: unrestricted area? MR. AYRES: MR. CAMPER: Yes. And all I'm saying is that would be Yes. That's at the boundary of the Actually, you're referring to the Yes. They normally do it in -- what a function of the size of the room. MR. AYRES: Yes. But what they normally do is roll in a PDR in a standard manual low-dose patient treatment room. MR. CAMPER: what you're saying. Yes. I understand. I understand I think to get to the crux of your concern, I think your statement in Item 2, your last sentence, I think you've captured it well, "For PDR afterloading devices, the licensee should specify the configuration of portable shields, if applicable, used for each set of calculations." It seems pretty -The tendency I see with the people MR. AYRES: who want to use portable shields for HDR are those who try to put them in -MR. CAMPER: Nonexisting -- 144 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 meetings. MR. AYRES: That's right. MR. AYRES: MR. CAMPER: MR. AYRES: MR. CAMPER: -- an orthotherapy -Right. That's right. -- room or simulator room. That's right. Or to turn a room that really CHAIRMAN STITT: isn't adequate into something that will pass. MR. AYRES: Yes. All right. In another -- CHAIRMAN STITT: MR. CAMPER: It is typically in a transition, too, that they're wanting to do that. MR. AYRES: Well, the one I did the TAR one, they wanted to do it permanently. MR. CAMPER: it in the floor. That's right. they wanted to mount That's right. They wanted to use a portable shield and mount it in the floor. MR. AYRES: MR. CAMPER: DR. HOLAHAN: And one hanging over the patient. That's right. Now there's a pretty scary thought. Other comments on the section CHAIRMAN STITT: that we're working on, "Shielding"? MR. AYRES: and it isn't explicit. CHAIRMAN STITT: That's why we have these Here I thought I had addressed that, 145 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 may be. MEMBER QUILLEN: is not going to be. MR. CAMPER: It wouldn't be, would not be. They would not be. Well, but for a worker probably an hour. MEMBER QUILLEN: what period? All day long? For three days, three-four days. Three or four days. If you use Half an hour of an hour over Page 20. dose." CHAIRMAN STITT: MEMBER QUILLEN: Bob Quillen, anything here? No. The only item I had was on And it was Item 4, on "Calculations to determine the This is both HDR and PDR. And with PDR you'll have to explain to me how often, on what periodicity, I should say, these things operate? hours per day, or -CHAIRMAN STITT: MEMBER QUILLEN: MR. AYRES: Well, several minutes an hour. Several minutes an -Which do you have them on, how many To upwards of an half an hour out of MR. AYRES: MEMBER QUILLEN: a continuance occupancy factor of one, you would be doing a calculation based upon a total day's exposure, then, as if somebody was there 24 hours a day. MR. AYRES: Which a patient in an adjacent room MEMBER QUILLEN: MR. CAMPER: If you have someone sitting at a 146 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Bob? MEMBER QUILLEN: case it's reasonable. Yes. I think this is for one desk or standing in one place all the time. MEMBER QUILLEN: Well, I would say continuance occupancy factor of one would be based upon somebody who is not an occupational worker, not a worker in the petroleum. You're making a possible worst-case scenario for a facility where -MR. AYRES: Well, this is unrestricted areas where we're considering the public. MEMBER QUILLEN: CHAIRMAN STITT: MR. CAMPER: Yes. I know. And I think he -But you still should use a realistic occupancy factor. MR. AYRES: MR. CAMPER: Well, we said -That's what you were saying. Right, In one case it's not reasonable. But I think the argument -We say we will accept less, but And if you DR. HOLAHAN: MR. AYRES: you've got to at least show us it's reasonable. don't want to actually demonstrate what the occupancy factor is, then one is a conservative way to go. MR. CAMPER: No question. Yes. But you use the term MEMBER QUILLEN: "compelling." 147 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 homeless. CHAIRMAN STITT: MEMBER QUILLEN: Only in D.C. If I were writing this, I would MR. AYRES: DR. HOLAHAN: MR. CAMPER: Well, "compelling" might be -I think we have -The fact that we have someone in that station 25 percent of the time and using a quarter occupancy in and of itself is legitimate rationale. MR. AYRES: MR. CAMPER: Yes, yes. I don't know if that's compelling or not, but it's legitimate. DR. HOLAHAN: But I think it depends on what the unrestricted area is because, again, as Bob said, if it's a patient room next door, then you may well have a patient in there full time. Also in some cases we've had licensees come back and tell us, "Well, it's just a stairwell in there" or something. And we say, "Yes. you going to verify?" But just make sure. How are And there have been some cases where you've got people residing -CHAIRMAN STITT: DR. HOLAHAN: In the stairwell? Well, or in a closet or things, have said, "should consider an occupancy, a factor appropriate for the use of the adjacent area." 148 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 though. one. MR. CAMPER: I think that makes sense, Bob. I mean, that principle holds true whether you're developing, designing an X-ray suite or a therapy suite. truism. I mean, that's a Use the occupancy factor that is appropriate and design your shielding and your distance accordingly. DR. HOLAHAN: But that also means you need to tell us what the adjacent areas area. MR. CAMPER: Sure. That's -- CHAIRMAN STITT: MR. CAMPER: MR. AYRES: And explain it. And explain it. I think it should stay in there, Absent any information, it will be presumed to be I mean, all I'm saying is that one is the default valve. MR. CAMPER: Well, wait a second. If you put some words in like Bob is suggesting, Bob Quillen is suggesting, say "Calculations to determine the dose received by individuals present in unrestricted areas should consider occupancy factors appropriate to or consistent with the actual use of the actual presence in adjacent areas." DR. HOLAHAN: MR. CAMPER: "Possible use." In the case of a patient in an adjacent room, the occupancy factor would be assumed to be one. MEMBER QUILLEN: mean, that's -Yes. You can put that in. I 149 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 20. MR. CAMPER: argument to that. But let me just give you the MR. CAMPER: See, the way you've got it now, it And that's a really leads them with a bridle on to one. little strong. MR. AYRES: MR. CAMPER: Yes. I understand your conservatism. And that's a legitimate concern. But I think that if you capture words such as Bob was suggesting and then call out the point that if it's a patient -MR. AYRES: All I want to do is -- you know, I think, yes, it needs to be changed and say, you know, "Provide us the information. assume one." MR. CAMPER: specifically. MR. AYRES: MR. CAMPER: Yes, yes. Okay. That was my only comment on Page Well, you could say that But absent the information, we will MEMBER QUILLEN: One could argue that, "Absent that information, you should ask." MR. AYRES: Well, if they want to take the most conservative number, why ask? MR. CAMPER: conservative number. No. We would be taking the most 150 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: MR. CAMPER: we would be taking -MR. AYRES: MR. CAMPER: assume one." MR. AYRES: Yes. Well, why should we ask if they Right. "If you don't give it to us, we will Right. the way you structure that comment, don't want to provide it and just presume one or they just presume one themselves? MR. CAMPER: I'm just saying there are two ways One would be if it's you can -- two ways we could take that. not specified, you could specifically ask so that you would be getting the best data possible or you can take the conservative approach, "We will assume one." MR. AYRES: MR. CAMPER: Yes. And as long as we alert them to that, I mean, that's reasonable. MR. AYRES: Well, actually we shouldn't have to alert them because that should be in their calculations. They've got to presume an occupancy factor in the calculations or -MR. CAMPER: it the way -MR. AYRES: It needs a little -Okay. Yes. I'll revisit that one. Well, again, I think if we structure 151 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: DR. HOLAHAN: It should work. You should also maybe indicate that they should -- remind them to describe what the adjacent areas are. MR. AYRES: MR. CAMPER: facility diagram? MEMBER QUILLEN: DR. HOLAHAN: MR. AYRES: Yes, you are. Yes. Are we clear about that point in the Are we? One of the problems that assuming one takes care of and using a specific value doesn't if the use of the room changes. Then one would need to put some language in here that they will have to amend their licensee with new calculations if the room usage changes; in other words, they convert the room from a treatment planning room to a patient room or whatever. MR. CAMPER: I had a comment now that we've Under 10.1.2.1, "Facility gotten back into that section. Diagram," we have a sentence there which I know why you have it in there, but I must tell you it's a little troubling as I read it. It says, "The patient room should be as far away from the nursing station and heavy traffic hallways as is consistent with good medical care." DR. HOLAHAN: MR. CAMPER: I think we also said that in the -Well, what bails us out of that 152 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 basically. DR. HOLAHAN: Yes. It's the ALARA sentence is "as is consistent with good medical care." In other words, I could readily see why one would want to develop a room in which it was very close to a nursing station because of the fact that this procedure is ongoing for a long period of time and you want to be able to have good monitoring. The reason you've done this, of course, is because of exposure rate. exposure rate. Page 18. Yes. We use that same language in the But, you know, you can design to MR. AYRES: DR. HOLAHAN: manual, "brachytherapy module," as well, basically to -CHAIRMAN STITT: DR. HOLAHAN: discuss tomorrow. CHAIRMAN STITT: Is that right? And this was the fire language. Which module? Manual brachytherapy, one we'll Is that somewhere? I mean, couldn't you modify? MR. CAMPER: Instead of saying that the room should be as far away from the nursing station, couldn't you say something along the lines of "The room should" -- let me give you the thought. The room that is used should be consistent with providing good medical care while considering a means to reduce the exposure. MEMBER QUILLEN: It uses its own ALARA concept, 153 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 located. MR. CAMPER: That's right. I mean, the idea of considerations. And I think that -You've got good medical care and MEMBER QUILLEN: ALARA combined. And you have to balance the two. Right. So maybe you should make that DR. HOLAHAN: CHAIRMAN STITT: statement, instead of saying -MR. CAMPER: That's what I -- well, yes, but --- where the room should be CHAIRMAN STITT: saying the room should be -CHAIRMAN STITT: MR. CAMPER: is a little troubling. CHAIRMAN STITT: MR. CAMPER: Yes. Just say put it where. -- far away from the nursing station You should say that the placement of the patient room should bear in mind principles of ALARA and good medical care. CHAIRMAN STITT: I've actually worked in institutions where they were right next to the nursing station -MR. CAMPER: Absolutely. -- for that very reason. You design it CHAIRMAN STITT: MR. CAMPER: accordingly. Absolutely. That's what lead in the wall is for. 154 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is raising. medical care. so forth. DR. HOLAHAN: That language came out of Appendix DR. HOLAHAN: MR. CAMPER: Currently in the -There are Pb-lined glass windows and R of the existing Reg. Guide 10.8. MR. AYRES: DR. HOLAHAN: Yes. It says, "The patient's room will be as far away from the nursing station and heavy traffic hallways as consistent. It will be a private room unless the dose rate at one meter meets requirements in 20.105(a) and" -MR. CAMPER: DR. HOLAHAN: MR. CAMPER: Well, I understand. Okay. And I still have the same problem I'm not saying it's with it as a matter of principle, though. poor, inadequate. it. I'm just saying there's a better way to say I mean, what you're really getting at is what Bob It's really about ALARA and at the same time good And you place your room with those things in mind or you design your room accordingly. DR. HOLAHAN: So you're saying to revise it to say something about it should be located to take into consideration both ALARA considerations and good medical care. The problem is then people come back and say, "Okay. you mean?" What do 155 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 understand. MEMBER QUILLEN: DR. HOLAHAN: MR. CAMPER: That's their problem. They can figure it out; right? I think health physicists Physicists understand that concept. DR. HOLAHAN: You're assuming again that everybody has a physicist on staff. CHAIRMAN STITT: This is pretty high level stuff. I mean, they're either going to have a good contractor or they're going to have a physicist on the staff. I don't think it's the same as talking to the housekeeping people. DR. HOLAHAN: Okay. No. He says it's not. I mean, here MEMBER QUILLEN: CHAIRMAN STITT: you're saying it should be far away. I think you should not tell them where it should be but tell them that the issues you're dealing with are ALARA and medical care and let them figure out where it should be because it's going to be different in different facilities. MR. CAMPER: See, actually you have three things. You have exposure limits, I mean, those are the You have ALARA, good medical care. the boundary of unrestricted areas. three things you've got to consider. CHAIRMAN STITT: I want to make you folks work So -- through the end of the item that we're on. MR. CAMPER: What a taskmaster. 156 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Bob. DR. HOLAHAN: What? Wait a minute. What? Can sphincters. practice. short trip. DR. HOLAHAN: that is left. MR. AYRES: DR. HOLAHAN: It's huge. Item 11 is the rest of it. Okay? Item 11 is pretty much all left, CHAIRMAN STITT: I know. Well, I was trying to figure out if we could get through Item 11, but I don't think it's going to work. MR. AYRES: We don't have very -- short trip, CHAIRMAN STITT: Well, you can't go to 11 until you finish what we're working on. DR. HOLAHAN: Item 10. So just tighten those I need to CHAIRMAN STITT: I shouldn't say these things. All right. MEMBER QUILLEN: Can I just ask a question for clarification? Because on top of Page 18, the first line It says "general there, my copy is such that I can't read. information." Then the next word I can't read. Mine says "described CHAIRMAN STITT: previously." MR. CAMPER: We did that on your copy on purpose, you start with the beginning of the sentence because I think I 157 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 too. DR. HOLAHAN: It's only shifted by a line or two, -MEMBER QUILLEN: information." MR. AYRES: on Page 17 on my copy. DR. HOLAHAN: MR. AYRES: Okay. Thank you. "In addition to the general" -- it's "In addition to the general "Described previously in this guide." "Described." Okay. MEMBER QUILLEN: DR. HOLAHAN: MR. CAMPER: Okay. Just as a matter of record, you and Bob are working from a different copy than we are? DR. HOLAHAN: I just put it straight up. And I Yours is think it's the difference in the type that was done. somewhat smaller type. MR. AYRES: DR. HOLAHAN: differently, but it did. MR. AYRES: Yes. Yes, yes. And I don't know how it came out I just printed a fresh one, but it's enough that we're scurrying every time you -MR. AYRES: Well, I have a copy of that. I sometimes go back to those. DR. HOLAHAN: MR. AYRES: Yes. Yes. OGC's comments are the -We have, it looks like, 10 and 158 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 shields? MEMBER QUILLEN: And then you go to "consistent 12-point pitch type. DR. HOLAHAN: Yes. Okay. MEMBER QUILLEN: paragraph, then -CHAIRMAN STITT: Is that correct? MEMBER QUILLEN: CHAIRMAN STITT: MEMBER QUILLEN: Well, going back to that We're under "Facility Diagram." "Facility Diagram." 10.1.2.1. "In addition to the general information described previously in this guide, provide a description of any additional shielding of proposed patient rooms used for implant therapy." with facility diagram? requirements. Isn't it? Does that refer to temporary What does that have to do It has to do with additional shielding CHAIRMAN STITT: with good medical care," which is really -- the paragraph heading doesn't describe what's in your paragraph is what I'm saying. DR. HOLAHAN: Well, except the facility -- your location of your patient room -- again changing it in light of what we just discussed with the ALARA and the good medical care, that is part of the facility diagram where you can actually locate it. 159 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 reexamined. into LDR. devices. DR. HOLAHAN: Yes, but on Page 13, the overall And then I think your shielding would be part of your facility diagram. You're using additional shielding. Well, it talks about portable MEMBER QUILLEN: shields, too. DR. HOLAHAN: But those would also be part of what you're using in your facility to comply with -MR. AYRES: If your permanent shielding isn't adequate from your facility diagram, you're going to have to address that issue. MEMBER QUILLEN: I just found the paragraph heading to be not descriptive of what information you were searching for in the paragraph. MR. AYRES: DR. HOLAHAN: Okay. Oh, okay. Well, yes because, And this actually, 10.1 is entitled "Facility Diagram," too. is like a subheading of a subheading. MR. AYRES: This is specific to low-dose rate topic is "Facility Diagram." MR. AYRES: DR. HOLAHAN: Yes. Then we go into HDRs. Then we go So I think we need to -MR. AYRES: Yes. Okay. I see. It needs to be 160 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 much as -MEMBER QUILLEN: Yes. It's not the content. The different. CHAIRMAN STITT: MEMBER QUILLEN: CHAIRMAN STITT: Would that be right, Bob? Yes. Okay. It's not the content as part. CHAIRMAN STITT: All right. So we like what it CHAIRMAN STITT: complaining? DR. HOLAHAN: MR. CAMPER: No. She was just asking where. Or retitled. Is she Simon Legree has us moving to this says, but we'd like to call it something else? DR. HOLAHAN: We'd like to call it something content just doesn't follow the -MR. CAMPER: MR. AYRES: Right, right. I'll play with that. So we'll find some other way to CHAIRMAN STITT: describe that. All right. "Viewing and Intercom Systems," "Warning Systems and Access Control." DR. HOLAHAN: How about "Diagrams"? That's what it's called under the HDR section. CHAIRMAN STITT: DR. HOLAHAN: What's it called? "Diagrams." 161 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 CHAIRMAN STITT: That's what it is. You're asking for diagrams in Paragraph 1 and 2. MR. AYRES: Okay. So noted. How about "Viewing and Intercom CHAIRMAN STITT: Systems" as well as "Warning Systems and Access Control"? MR. CAMPER: Again, we're only under LDR here. Remote LDR. Is that right? CHAIRMAN STITT: MR. AYRES: DR. HOLAHAN: Yes, remote afterloading. Yes. Right. CHAIRMAN STITT: DR. HOLAHAN: Manual will be dealt with tomorrow. Okay. There's no issue on CHAIRMAN STITT: remote low-dose rate that comes up in the high-dose rate regarding moving the devices? Is that correct? Are we happier with relocating LDR devices than we are with relocating HDR devices? MR. AYRES: Right. Just recently I've addressed And our current We this issue with some guidance to the regions. position as set forth in that is you can't move them. grandfathered those that we're permitted to. CHAIRMAN STITT: MR. AYRES: HDRs. HDRs. All right. LDRs we're talking about? CHAIRMAN STITT: MR. AYRES: But we won't consider it unless the devices meet the new requirements for transportability for 162 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 future licenses. CHAIRMAN STITT: issues that -MR. AYRES: Not one of the issues. So this is all looking fine. But LDRs, that's not one of the CHAIRMAN STITT: How about in the last paragraph on 18, "Warning Systems and Access Control," specifically in regards to relocating? Everybody's happy with that? I'm not questioning. DR. HOLAHAN: MR. AYRES: Right. Yes. The only special thing in there I just want to discuss it. is when they move it, they reconnect whatever interlock protective systems they have, they be tested before they begin treatment. MR. CAMPER: MR. AYRES: MR. CAMPER: Bob, a question for you. Yes? Bob Ayres, on Page 19, under 10.2, "Survey Instruments," is this clearing up that confusion that exists on 35? MR. AYRES: No. This goes with the existing requirements because this is LDR. DR. HOLAHAN: Well, actually, no. The survey And that goes Isn't instruments, that's just what you must have. back to 420. That's not use of survey instruments. that under operating procedures? 163 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the LDR? MR. AYRES: Same as conventional low dose. What? them? 35.420. MR. CAMPER: No, no. How do you get to both of MR. AYRES: Yes. See, this requires both here. It says you've got to have both of them. DR. HOLAHAN: MR. AYRES: Okay. This is a -- That's just reiterating, if you will, Where do you see that? DR. HOLAHAN: MR. AYRES: Because 420 -"Licensee shall confirm the possession and availability of a portable radiation detection survey instrument and a portable radiation measurement survey instrument." That's both of them. It's under operating procedure is DR. HOLAHAN: the question you're asking? MR. CAMPER: What's the national dose rate from Twenty r per hour or something like that? MR. CAMPER: Why do you want somebody to have a survey measurement instrument capable of a range up to 1,000 millirem per hour? DR. HOLAHAN: MR. AYRES: Because 420 -Well, I didn't see any particular reason in granting any -- I mean, that's what's required for conventional manual afterloading brachytherapy and -- 164 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 document. DR. HOLAHAN: That's the structure of the way the follow. MR. AYRES: Well, that's the structure of the MR. CAMPER: regulation problem. MR. AYRES: DR. HOLAHAN: That's a regulation problem. Section 10.2 applies to both HDR Well, that's true. I mean, that's a and LDR remote afterloaders, that section you're reading on survey instruments. MR. AYRES: DR. HOLAHAN: MR. CAMPER: DR. HOLAHAN: MR. AYRES: DR. HOLAHAN: Yes, it does. It's now out of -- Now, I'll switch from -No. No. Yes, it does. It dropped from 10.1. Anything with a 10.1.2 addresses low-dose rate. MR. AYRES: DR. HOLAHAN: into a new section. MR. AYRES: Yes. You can keep track of things Yes. Then once you get to 10.2, you're better by always referring to the indented. MR. CAMPER: I see. Well, that's not easy to Reg. Guide is written, and all Reg. Guides are written into -MR. CAMPER: Yes, yes. Okay. I see what the 165 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1,000? MEMBER QUILLEN: MR. AYRES: Yes. approve it. MEMBER QUILLEN: I'll just for the record make a Okay. MR. AYRES: If you promise to sit on OGC, I'll problem is. be improved. DR. HOLAHAN: MR. AYRES: DR. HOLAHAN: we revise Part 35. MR. CAMPER: Yes. Okay. I see the problem. Correct. Right. Hopefully we can deal with that as Also, frankly, 35.420 as currently written could comment that when we adopted our version of Part 35, that medical physics consultants came to me and said, "Look, there's no good one instrument that will do this." So what we wrote our regulation to say is, "You will have survey capability between these two ranges. And I don't care whether you use one instrument or two instruments or three instruments." MR. CAMPER: You're saying to go from .1 to I understand there are instruments available now that will cover that range. MEMBER QUILLEN: manufacturer is saying. Well, that's what the People who practice in the field say 166 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 comments. MR. AYRES: One little sneaky thing I put in here on this? no. MR. AYRES: MR. CAMPER: Maybe. Okay. All right. Any other comments Bob CHAIRMAN STITT: We're winding up through this section here? Quillen, other things you have to comment on? MEMBER QUILLEN: No. I think I've made all my just looking ahead, just a comment the reason of it, on Page 20, on Item 5, I put "units of rem or millisieverts." The reason for that is at least in Russia and maybe some other places in Europe and maybe -- I'm unaware of in the U.S., but there are some RAL procedures, at least being used and investigated using neutron sources; in particular, Californium 252. So I was just anticipating. MR. CAMPER: Bob, I noticed here on Page 21 -I just haven't thought about it and you may have done this. before now. In Item 6(b), where we're saying a "dose within 0.5 rem (5 millisieverts)," have we used English and standard international units throughout? but -MR. AYRES: MR. CAMPER: I tried to. Okay. That's an editorial -I would double-check that, MEMBER QUILLEN: 167 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 around. MR. AYRES: Well, it used to be. I think it's MR. CAMPER: As we move towards complete implementation of our metrification program, we should make sure we're doing that. thought. MR. AYRES: I think the latest comments I got Anyway And perhaps you have. It's just a from our tech editor is -- I may need to change this. I think now we've done the switch and metric goes first. DR. HOLAHAN: MR. CAMPER: Yes. I thought it was the other way now we've -- I'll check that. DR. HOLAHAN: MR. CAMPER: the agency policy. DR. HOLAHAN: The only point that I just wanted It's -- yes. Okay. Whatever is consistent with to make quickly -- and I just wanted to raise it on the table -- is on Page 19 under "Security of RAL Devices," one of the questions that has been posed to me when I have been talking to individuals is: For security of the device, if you shut it off with the keys and everything else, there does -- how far away does an individual have to be to take the key with them? And what is unattended? And I don't know. Do we need to spell that out any further? Because there's been a question, "Look, I've done 168 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 procedures. unattended. all my warm-up and everything else, and I'm going off to do this. But I don't want to shut the whole unit down to take the keys out." CHAIRMAN STITT: What are the possible actions that would be acceptable or not acceptable? DR. HOLAHAN: raise it because it -MR. CAMPER: Why would I not want to take the key I don't know. I just wanted to with me if it was unattended? DR. HOLAHAN: hall to my office. CHAIRMAN STITT: unattended means. MR. AYRES: DR. HOLAHAN: MR. CAMPER: Well, device is -Well, I guess that's -Still, at that point it is It is not in use. Maybe it depends on what Because I'm only going down the It is not being monitored. CHAIRMAN STITT: But you've just done your warm-up procedures? DR. HOLAHAN: You've done your warm-up The patient isn't You've done You've done your dosimetry. there -- or no. You haven't done your dosimetry. your warm-up procedures and everything else. The patient isn't there yet. You're leaving it But you don't for 20 minutes until the patient gets there. 169 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it's not. CHAIRMAN STITT: secured areas. DR. HOLAHAN: MR. AYRES: Right. Right. The machines are, but the Consoles aren't necessarily in have. want to sit and watch it, sit beside it while you're waiting for that patient to come down. MR. AYRES: My personal reply to that would be if Make the access door Then I were asked that question, "Well, okay. to the treatment facility lockable and that be locked." the keys are not accessible. accessible. MR. CAMPER: It's just not. DR. HOLAHAN: Okay. The console key is not That's not a healthy situation to I'm just raising it because the question has been raised, and I just wanted to put it on the table to see if there is, you know -MR. AYRES: That's done. You know, it's not locked during treatment, of course, but if you had your door to your treatment room lockable, then you could leave the device in and power it up because you've -DR. HOLAHAN: But the console is outside. So CHAIRMAN STITT: consoles aren't. MR. AYRES: But if the source was under a locked 170 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 warmed up." MEMBER QUILLEN: but it's under observation. CHAIRMAN STITT: MEMBER QUILLEN: CHAIRMAN STITT: That's acceptable. Yes. I think we ought to be specific "And we're going to keep it on," shield, which we would by locking the treatment room door, somebody runs out, so what, I mean? MEMBER QUILLEN: could put in here. Well, there's another thing you You could say it's not in use or is unattended and not under observation because sometimes when you mean attended, you mean somebody is standing there. other cases something's unattended, but it's under observation. MR. CAMPER: MR. AYRES: Right. Again, it's a bit of a definition In thing, I guess, you know. MR. CAMPER: Well, you could, but you could put Where it says "unattended," an "i.e." after "unattended." there is not not under observation -- or you could say "not being directly observed" or something to that effect. MEMBER QUILLEN: We've come into this same question with linear accelerators, where they say, "Look, there's nobody standing at the control panel." MR. CAMPER: Yes. "We're fired up, keeping 171 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 persons." CHAIRMAN STITT: What's the circumstance where a because this is a common, ordinary household problem. use or unattended. Not in We You can read it to mean "It's Tuesday. don't do these procedures on Tuesdays." than "We've got it warmed up. Yet, that's different We're waiting for the patient." It's not in use, but it would still be under observation. MR. CAMPER: Well, you see -Do you want to -- CHAIRMAN STITT: MR. CAMPER: See, someone might argue "If I'm warming it up, it is, in fact, in use." MR. AYRES: MR. CAMPER: MR. AYRES: MR. CAMPER: another type of in use. That's also. MR. AYRES: The observation is one method of Yes. That's a legitimate argument. There are different types of in use. Yes. Irradiating the patient. That's I'm preparing it for irradiation. ensuring the console keys are inaccessible to authorized persons. DR. HOLAHAN: MR. CAMPER: MR. AYRES: Unauthorized persons. Unauthorized, right. That's what I said, "unauthorized patient has got an applicator in place, films have been done, the nurse is in the room with the patient, the console is 172 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 with them. DR. HOLAHAN: MR. CAMPER: They can't. No, they can't. But that would fit this outside, and then the team that's just taken the films and done the planning has gone off to the -MR. AYRES: Then they had better take the keys CHAIRMAN STITT: definition of not -MR. CAMPER: DR. HOLAHAN: MR. CAMPER: That's right. Not attended. So under that circumstance you would want it to be under observation. MR. AYRES: Yes. Because it would be under CHAIRMAN STITT: observation is a -MR. AYRES: You're really self-explanatory. That's one method of assuring that the keys are inaccessible to unauthorized persons. One method is that whenever the keys The are in the console, they're under constant observation. console is under constant observation. CHAIRMAN STITT: That's a method. There are a lot of fine points when it comes down to how you really clinically use these things people are either going to achieve or not achieve depending on how you use this and also what your intent is. When I read that, my mind thought "Oh, this is 173 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 when the machine is not being used at all." MR. AYRES: Well, that's certainly included, yes. Well, that's easy. That means CHAIRMAN STITT: they shouldn't be in the -DR. HOLAHAN: They shouldn't be. Like in the copier. The keys to But that's a CHAIRMAN STITT: the copier are always in the door by the copier. black and white. the gray. area. And I think the operating circumstance is Well, it's a problem And that's a lot more common. And you could get partly through that if you used observation. MR. AYRES: Yes. I don't think things like this should be too specific because there are a lot of ways -MR. CAMPER: Furthermore, the keys should always be inaccessible to unauthorized individuals. MR. AYRES: MR. CAMPER: MR. AYRES: Well, of course. Always. Maybe the sentence -- Well, this is presuming that they're inaccessible when you're actually operating the machine because you're going to fight them. MR. CAMPER: DR. HOLAHAN: Well, what I'm trying to say is -Just say "This should include the methods for use to ensure that the console keys will be inaccessible to unauthorized persons." MR. CAMPER: That's right. 174 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MEMBER QUILLEN: MR. CAMPER: DR. HOLAHAN: MR. CAMPER: DR. HOLAHAN: MR. AYRES: MR. CAMPER: That's your goal, yes. That's the goal right there. And just take out that -Yes. I thought about -- -- parenthetical phrase. Yes. Yes, yes. I mean, that's the goal. You want the keys to make -DR. HOLAHAN: You don't want somebody who shouldn't have the keys wandering around the hospital with them. CHAIRMAN STITT: MR. CAMPER: DR. HOLAHAN: Right. Right. Because whether it's in use or unattended or not, they shouldn't have them. CHAIRMAN STITT: Right. And we're making it Is everybody else happy simpler, instead of more complicated. with that? MR. CAMPER: Yes. I think that will work. Okay. We're talking about CHAIRMAN STITT: "Adequacy of Shielding for HDR and PDR Devices." MR. AYRES: Yes. We've been through that. CHAIRMAN STITT: MR. AYRES: Yes, we've been through that. I knew that looked familiar. CHAIRMAN STITT: 175 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to do." CHAIRMAN STITT: People are happy. Right. So we like a referee. MR. CAMPER: Mrs. Earl would be proud of you. Very good. You don't want to get the people controls." MEMBER QUILLEN: DR. HOLAHAN: Right. MEMBER QUILLEN: One last comment on Page 18. The last sentence on Page 18, at least my Page 18, which ends in "should be described," I had to read that sentence three times to understand it because of where the verb is placed. DR. HOLAHAN: area controls." MEMBER QUILLEN: DR. HOLAHAN: Yes. But saying "Describe restricted "Describe your restricted area Make it "active." You'd make a good journal CHAIRMAN STITT: CHAIRMAN STITT: MEMBER QUILLEN: frustrated when they read something like that. CHAIRMAN STITT: MEMBER QUILLEN: That's true. Absolutely. They get frustrated because I don't" -- "What do these people want me to do? CHAIRMAN STITT: MEMBER QUILLEN: Start with an --- "understand what they want me "Here's what you're supposed to do." All right. 176 1 2 3 4 5 6 7 8 9 10 11 12 13 14 1:00? (Whereupon, a luncheon recess was taken at 12:19 p.m.) shielding section. That's 10.6. Have we been through all of 10.6 that we need to discuss, including the words on Page 21? Got anything on your page? MEMBER QUILLEN: CHAIRMAN STITT: No? No. Okay. I'm ready for 11. Bob Ayres, are you ready for 11 or lunch, whichever comes first? MR. AYRES: Lunch. Folks to my left? CHAIRMAN STITT: MR. CAMPER: Lunch. Okay. Good. Can we be back at CHAIRMAN STITT: 177 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 same thing. MS. HOLAHAN: Currently, there have been no yet to go. MS. MERCHANT: Okay. A-F-T-E-R-N-O-O-N S-E-S-S-I-O-N (1:16 p.m.) We're back on the record. All right. Page 21, item 11. CHAIRPERSON STITT: I believe all we have left is item 11, is that correct? MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: Well, there's a small 12. Very small. Yes. But half of the document is CHAIRPERSON STITT: So radiation safety program, leak tests, a lot of Why don't we have you lead off here? Well, the only comment I had was blue lining over here. MEMBER QUILLEN: on the next page there. CHAIRPERSON STITT: MEMBER QUILLEN: Okay. On page 22, that refers to Appendix L that I didn't have, so I couldn't review that. MR. AYRES: That refers to Reg. Guide 10.8, which is a leak test procedure, and I don't know if that's getting any change or not. MEMBER QUILLEN: external exposure program. MS. HOLAHAN: MR. AYRES: Oh, you're on personnel monitoring. Oh, I was reading -- okay. It's the It says here it's personnel 178 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 changes made to those, but I think that's something that we were going to look at and see if there were changes that need to be made. MR. AYRES: MS. HOLAHAN: Yeah. But they are the appendices from the existing Reg. Guide 10.8, as it stands today. MR. AYRES: This is written with -- in view of the fact that this will be one chapter in that Reg. Guide, so -MEMBER QUILLEN: Okay. It talks about calibration pocket dosimeters also, and I have yet to see a pocket dosimeter that could be calibrated. I can see where you can shut the calibration on it, but I can't see how you could calibrate one. CHAIRPERSON STITT: So you're suggesting that calibration ought to come out of that sentence, procedures? MEMBER QUILLEN: All I'm doing is -- frequency for calibration checking of pocket dosimeters. CHAIRPERSON STITT: MS. HOLAHAN: Yes. Does it talk about I don't -Does anybody have 20.1501(b)? CHAIRPERSON STITT: calibration of pocket dosimeters? MS. HOLAHAN: 1501 was it? 1501(b). 1501(b) says, "The licensee MEMBER QUILLEN: MS. HOLAHAN: Okay. 179 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 dosimeters. MR. AYRES: Right. What this sentence, just shall ensure that instruments and equipment used for quantitative radiation measurements are calibrated periodically for the radiation measured." MR. AYRES: MS. HOLAHAN: Yeah. What this -- And (c) is all personnel covers that eventuality. If you use pocket dosimeters to monitor personnel exposure, not that -- that's when you've got to calibrate them. And so if you can't calibrate them, you So this covers that -- can't use them for that purpose. CHAIRPERSON STITT: MEMBER QUILLEN: What comments do you have? Well, I've never seen a pocket You can check the dosimeter that you could calibrate. calibration on it, but you certainly can't calibrate. MR. AYRES: But then, have you seen these dosimeters used in lieu of film badges, for example? MEMBER QUILLEN: Well, I haven't been in practice for a long time, but at one time, yes. CHAIRPERSON STITT: MEMBER QUILLEN: (Laughter.) MR. AYRES: statement, I guess. Yeah, it's a back-handed exclusionary Yeah, I have, too. Many years ago. It says if you can't calibrate them, you can't use them for this purpose. 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MEMBER QUILLEN: Okay. Are you going to let it go, CHAIRPERSON STITT: or do you want to -- you want "calibration" taken out of there? MEMBER QUILLEN: MR. AYRES: I'd just -As the I might -- one suggestion. primary means of monitoring personnel exposures. MEMBER QUILLEN: MR. AYRES: Where would you put that in? If you use pocket dosimeters to monitor and change to monitor as the primary means of monitoring personnel exposures. MEMBER QUILLEN: That would help. CHAIRPERSON STITT: Would it still be okay to say Yes, I can understand that. "frequency for calibration and maintenance, as required"? MR. AYRES: Primary method, then. The next sentence. CHAIRPERSON STITT: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: MR. AYRES: What was your first fix, Bob? What? What was your first fix? Well, that was it. I missed it. If you use a pocket dosimeter as the It was -- primary method of monitoring personnel exposures. MS. HOLAHAN: Okay. 181 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 okay. MR. AYRES: MS. HOLAHAN: and procedure -MR. AYRES: -- monitoring personnel exposures. As the primary method of -It should provide the useful range dosimeters? MEMBER QUILLEN: MR. AYRES: MS. HOLAHAN: Okay. Okay. That's -Yes. now? MEMBER QUILLEN: I'd take "a pocket" because now electronic? MEMBER QUILLEN: MS. HOLAHAN: Okay. MEMBER QUILLEN: electronic dosimeters? MR. AYRES: How about either use pocket or What are you doing about So do you think that's still a problem, having it in as -- having "calibration" in there? MEMBER QUILLEN: MS. HOLAHAN: Well, I would take -- Or are we taking "calibration" out you've added electronics, so I'd say "such dosimeters," or whatever. MR. AYRES: Just if you use electronic MEMBER QUILLEN: MS. HOLAHAN: If you use electronic dosimeters, 182 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Ayres? MR. AYRES: No. Okay. Implant source record I MS. HOLAHAN: Okay. By the way, just as a correction, I just as I was looking it up, it's Appendix D, not Appendix L that is the personnel monitoring. just a -MR. AYRES: MS. HOLAHAN: Oh. Changed L to D? That was Change L to D. Okay. That's the only comment I MEMBER QUILLEN: had on that page. CHAIRPERSON STITT: Any other comments? Bob CHAIRPERSON STITT: and inventory, 11.14. don't -MEMBER QUILLEN: This looks very straightforward. One of the things that I thought would be helpful in here, and a lot of my highlights refers to records that you're supposed to keep, as if you had some place where there was a summary of all of the records that you had to keep. CHAIRPERSON STITT: just lists -MR. AYRES: Yeah. We actually generated a That's a good point, where it document, but now the NUREG -- I think it was the NUREG that listed all of the recordkeeper environments throughout our regulations. It was kind of interesting. 183 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 glossary. MEMBER QUILLEN: Because of -- for example, this Most of record of inventory has to be kept for five years. the other records have to be kept for three years. MR. AYRES: That's right. And a few, like the calibration of teletherapy units, have to be kept as long as you have the device. CHAIRPERSON STITT: Well, at the end, we have a Why don't we fix up something that would fit into this section, maybe at the end of the section or adjacent to the glossary and refer to it, and just list what's required. MR. AYRES: I would think this would need to be If we do run up the -- discussed a little more widely. something like this here, I think it applies to everything. MS. HOLAHAN: It would impact all of the modules. So the question is, do we want to have that sort of up front as a separate, stand-alone, all of the records that are required for each area? Or each -- if we have it for this module, we should have it in each of the modules as to what are the records, and what are the record protection requirements. CHAIRPERSON STITT: I think it would make a lot And it's of people's lives, including the NRC's life, easier. not creating anything new. list. MR. AYRES: It's abstracting and making a Yeah, I think that's one that maybe 184 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 about. MS. HOLAHAN: For the source inventory. You by far. MS. HOLAHAN: Right. But it just impressed me all of we make a note on. MS. HOLAHAN: MR. AYRES: Right. It's broader than just this module, MEMBER QUILLEN: the records you were going to have to keep based upon this section, and that there were some small differences in the length of time the records were going to be kept. But it would be helpful for the users to have a list to say, "Gosh, I know I have to keep all of these records." CHAIRPERSON STITT: the duration? MEMBER QUILLEN: Yes. And we could do it for all of So a list for the record and CHAIRPERSON STITT: the sections. MS. HOLAHAN: Yes. Bob, let me just -- because I just have a small question. Were we going to spell -- I notice you've got "referred to the standard license conditions." Were you going to spell out any more in the body as to what that included, or did you just -MR. AYRES: I'm not sure what you're talking don't describe the alternative method. You just say it's 185 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 addresses. MEMBER QUILLEN: Okay. That's one of the included in one of the standard license conditions. standard license conditions don't go to a licensee. need to spell it out in the Reg. Guide? MR. AYRES: MS. HOLAHAN: the licensees? MR. AYRES: MS. HOLAHAN: That's the intent. So it's -We do. They're attached here. Well, the Do we Will they be when it goes out to Because we don't -- we're not doing it with any of the other modules, to put the standard licensing -MR. AYRES: Well, Janet agreed that it was unique here because we had to do these "in lieu of's" all over the place, because 35.400 couldn't apply, or wouldn't apply. There was no way you could apply it. MS. HOLAHAN: MR. AYRES: Okay. And we had a unique situation here and, you know, you -- with remote afterloaders, no way to meet the requirements for manual -MS. HOLAHAN: MR. AYRES: Okay. -- which is all that 35.400 questions I was going to ask later on, because I wasn't sure whether the standard license conditions were going to be attached to this module. 186 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 anymore. MR. AYRES: That at least was the decision going in here after discussing it with Janet, and we removed attachment from them. They're just part of -Okay. Well, the thing says "in the MS. HOLAHAN: MEMBER QUILLEN: attached sample license condition," which is -MR. AYRES: Yeah, but it's not an attachment with an attachment number, and that sort of thing. MEMBER QUILLEN: It's -MR. AYRES: Yeah, because -- and these were So if we made them Okay. So it's not attached really attachments to Reg. Guide 10.8. attachments, they're attachments to attachments, and it got a little out of hand. MS. HOLAHAN: Were these only the standard license conditions that were in the P&GD -MR. AYRES: MS. HOLAHAN: Yeah, that's correct. -- or did you expand them to include the new ones that we're going to need? MR. AYRES: No, just the ones that were needed to get around 35.400, primarily. MS. HOLAHAN: Okay. No, I'm just thinking that that -- probably we need to consider either have them all in or because the thing -- it would be a standard license condition requiring the physical presence of the authorized 187 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 user and medical physicist. MR. AYRES: And so that's how it -- Well, then, I called them sample license conditions here. MS. HOLAHAN: Yeah, okay. Okay. If you're going to be MEMBER QUILLEN: doing that, this is another editorial comment, and that is the sample license conditions should have some sort of numbering system. So if you're going to cross reference the page 22 to the license conditions, you know exactly which one you're referring to. MR. AYRES: Just editorial -- that's a different way of doing things, but I'm not going to say it's precluded. MEMBER QUILLEN: I'm just trying to make it easier for the people to use this, so they don't go through here and wonder which one you're talking about. CHAIRPERSON STITT: Is that doable? It would certainly make it easier for the folks that are trying to understand how to use it. MS. HOLAHAN: Yes. You had some of the same CHAIRPERSON STITT: comments, then, Dr. Quillen, in your blue marker, all referring to required forms and duration. MEMBER QUILLEN: Right. You've got that throughout CHAIRPERSON STITT: your document, right? 188 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is -MS. HOLAHAN: Plus, it would be all part of the MEMBER QUILLEN: Right. So we're talking about CHAIRPERSON STITT: implant source record inventory and area survey, and let's include LDR devices. MEMBER QUILLEN: One of the questions I had It says, really goes over to the next page, page 24, item 4. "Record of survey results will be maintained for inspection by the Commission for the duration of the license." All of the other records are being kept for three years, five years, etcetera. MR. AYRES: That, again, is in 35. Yeah. Well, I just wondered, MEMBER QUILLEN: does that mean at the end of -- when your license is terminated, you can throw away all of the survey records, even if they're not three years old or five years old? MR. AYRES: Not the way I would read it. Once we release a facility as -- or return to unrestricted public use, we're done. MEMBER QUILLEN: Well, the reason I'm saying -- I mean, the termination of the license, there would be certain things that would have to be demonstrated -MR. AYRES: MS. HOLAHAN: Decommissioning. -- in terms of -- yeah, 189 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 decommissioning and bringing it down to acceptable levels. there are several license conditions that we use beyond what we use here that are required to be kept for the duration of the license. MEMBER QUILLEN: If I were a licensee, there were So some of these records I'd like to keep myself. MR. AYRES: Well, there's certainly nothing wrong with keeping records above and beyond our requirements for other reasons. CHAIRPERSON STITT: Yeah, and I don't think this implies that you have to destroy them at all. MR. AYRES: MS. HOLAHAN: keeping them. CHAIRPERSON STITT: MS. HOLAHAN: maintain them. MR. AYRES: somebody else. MS. HOLAHAN: MR. AYRES: Yeah. Hospital accreditation organizations, By us. You may be required by No. Not at all. Yeah, you're not precluded from You're just not being required to or professional accreditation organizations, or IRS, or whatever. CHAIRPERSON STITT: comments on page 23 or page 24? Bob, do you have other 190 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 can't go -MS. HOLAHAN: condition on page 38. And it corresponds to the license to go. MS. HOLAHAN: I'm sorry. Which page? You have to tell I go back? CHAIRPERSON STITT: You can go wherever you want MEMBER QUILLEN: That's all I have. Trish? Page 25 is operating CHAIRPERSON STITT: and calibration procedures. MS. HOLAHAN: Before we go back to -- on 27, can CHAIRPERSON STITT: us where you are, though. MS. HOLAHAN: Page 24. Okay. I was going to say, we CHAIRPERSON STITT: It's regarding the survey for HDR, and it's just an issue that has been raised in the sense that for LDR, for the survey required, in terms of 35.404, you only need to keep the initials of the individual who performed the survey. We specified the name of the individual making the Can we just have that as initials, too? I survey for HDR. mean, I know the issue has come up. MR. AYRES: Yeah. Well, it's currently a TAR, so I guess we need to see how that comes out. MS. HOLAHAN: Okay. But we accept the -- we do accept initials as a signature. 191 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Bob. MR. AYRES: What -- okay. Yeah, the second one, MR. AYRES: Well, what I did -- and I'll tell you how I got where I got -- and I'm willing to go back to the full thing, it's knowing these -- it's "in lieu of," it's the inventory thing, or who was authorized to get brachytherapy sources out of inventory. MS. HOLAHAN: By the way, for clarification, it's the second condition on page 38, the one that starts "in lieu of the source inventory." MR. AYRES: Yeah. Well, I've got a -- my 38 is CHAIRPERSON STITT: the glossary. That's part of -Oops. Then, it's the one that MS. HOLAHAN: starts -- is titled "Standard License Conditions." CHAIRPERSON STITT: MS. HOLAHAN: Sorry. In lieu of? Okay. CHAIRPERSON STITT: MS. HOLAHAN: Yeah, the second one. I'm with you now. Go ahead, CHAIRPERSON STITT: in lieu of 10 CFR 35.406. What 35.406 requires is a listing of who is authorized to do this, by name, and then when they do the inventory, they're to initial the inventory as having been completed. What I did was I -- when I did the "in lieu of," 192 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 name -MR. AYRES: Or it's the initials of the I said, let's see, MS. HOLAHAN: MR. AYRES: It's the second condition. (c), item (c), make a record of the survey, giving time, date, and name of the individual making the survey, which meets the name requirements of the existing 35.406. MS. HOLAHAN: So the existing 406 requires the name of who is doing the survey? MR. AYRES: MS. HOLAHAN: MR. AYRES: That's correct. Okay. It requires name and initial. It requires an authorized list. MR. CAMPER: MR. AYRES: MR. CAMPER: MS. HOLAHAN: MR. CAMPER: 406, what? 35.406. No, no, I know that. (b), is it? (b), (1) -- that's -(2) -- (b)(2). 406 -- MEMBER QUILLEN: MR. CAMPER: Yes. MEMBER QUILLEN: MR. CAMPER: MS. HOLAHAN: And (b)(3) also. And the initials -Yeah, but that doesn't require the individual who removes the -- 193 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MS. HOLAHAN: Oh, the names of the individuals permitted to handle the sources. MR. AYRES: MS. HOLAHAN: Right. And I guess the question is, could we do a similar thing with HDR, have the names of the individuals who are permitted to do the survey, and then they could just initial it at the time of their survey. MR. AYRES: MS. HOLAHAN: MR. AYRES: Sure. Okay. Or what I did was try to reach a compromise, just put down the name and -MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: Okay. -- instead of the name and initials. But that doesn't -- actually, that doesn't include an initial, does it? MR. AYRES: MS. HOLAHAN: No. So they're not really signing off that they've done it, so we may be better off to try and parallel what's currently required for the inventory, have a list of the names and then have them initial. MR. AYRES: Yeah, they could have it preprinted on the form or something, the survey form. MS. HOLAHAN: Or a listing over the AU -- I mean, if you've got a list of authorized users, or authorized physicists, or whatever, who would do the surveys, you could 194 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 prior -MR. AYRES: Yeah. What I did was make it a just maintain a list of that. MR. CAMPER: Yeah. It says that they shall make Now, I would imagine a record of brachytherapy source use. you could go about creating some ongoing record, wherein you would identify individuals for the record. But then you -- and their initials parenthetically, for example, I think if you use their initials. Now, we had a TAR also -MS. HOLAHAN: Yeah, and this is what were just referring to is there was a TAR in-house that people didn't want to put down their full name each time they did a survey. They just wanted to say, "Okay, this is who I am," and just initial off every time they -CHAIRPERSON STITT: So to keep the record like we talked about before, with -- of the individuals, plus their initials, and if we parallel the two systems, then we -MS. HOLAHAN: Right. -- are working in concert of CHAIRPERSON STITT: little bit shorter and not require the names and initial, but just the name -- enter their sign and ended up with both a name -MR. CAMPER: consistent, aren't they? But they're all supposed to be 195 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 comes in -MEMBER QUILLEN: -- my intent on this one was to almost. CHAIRPERSON STITT: So does that address the MS. HOLAHAN: Yes, because, actually, we don't Okay. require an initial or a signature currently. MR. CAMPER: Well, I also got the impression in one place we're requiring initials and in one place we're requiring a name. Is that correct? Well, the reason the name came in is MR. AYRES: this is this -- 406 is rather unique in having a specific requirement for the name to be listed. MS. HOLAHAN: And basically, it's because it's a list of the people authorized to -MR. AYRES: MS. HOLAHAN: MR. AYRES: It's an authorization. Yeah. Okay. It's kind of a "no, never mind" point you wanted to bring up, Trisha? MS. HOLAHAN: Yeah, I think we just needed to address it and perhaps make them consistent between the two, I think. MEMBER QUILLEN: MS. HOLAHAN: Well, my -- I mean, if it is something that wait until the TAR gets all signed off and then we'll see where that one stands. 196 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 24? MS. HOLAHAN: MR. AYRES: Yeah. Okay. I knew this one was, in fact, going through the technical systems request process with all concurrence. adjust this -MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: That we can adjust this, yeah. -- appropriately. Yeah, that could be done. All right. But let's do it And once that one is reached, I figured to CHAIRPERSON STITT: the same across the board. All right. So that's 24, then. 25? 26? Other issues on We were looking at 25. We're just listing page after page of a variety of issues relating to safety, the safety program. Bob, what do you have there? MEMBER QUILLEN: This gets back to -- and I think we discussed this earlier on the approved alternate. MR. AYRES: Yeah, okay. On page 27. Okay, right. That's not back. MEMBER QUILLEN: CHAIRPERSON STITT: MEMBER QUILLEN: 27, okay. CHAIRPERSON STITT: MEMBER QUILLEN: And so how do you want that? I just wondered what you had in mind as to who would be approvable as an alternate? MR. AYRES: Well, rather than being restrictive, 197 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 guess. MR. AYRES: permitted in -CHAIRPERSON STITT: Maybe we should strike And a trained dosimetrist we have I was hoping to get away with a general comment here. The way we've been dealing with this pretty much is on a case-by-case basis through a TAR process, or whatever, and I recently put out some, I guess, instructions on the bulletin guidance to the regions, listing those, at least to date, we had approved. And I -- I'm not sure I have -- I remember that all-inclusively. But, for example, for the authorized user, it would be a resident properly trained in the use of the device, working under -- or anybody working under the supervision of the authorized -- other physician working under the supervision of the authorized user. CHAIRPERSON STITT: an approved alternate? MR. AYRES: Well, then we restrict it to those, I Would that be preferable than guess, few cases that -MS. HOLAHAN: Or could we use it as an example, I "approved alternate," because that implies that there is a form to fill out and an approval process to go through, and I'm not sure that that's what we're trying to say. MEMBER QUILLEN: That's what the -- well, the first thing as I read it and I thought it's -- who is making 198 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the approval here? Because I wasn't sure who was making the approval, which is -CHAIRPERSON STITT: MEMBER QUILLEN: Yes. The second point is, I read it to mean that the authorized user had to be there, and then either the medical physicist or radiation safety officer or an approved alternate. MR. AYRES: has got to go, too. MR. CAMPER: MR. AYRES: That's right. We were just -Yeah. The radiation safety officer I fixed it in the one place that it was mentioned, and it -- you've got to look around through the document. MEMBER QUILLEN: So I didn't read this to mean that the authorized user would have an alternate -MR. AYRES: I agree, if everybody else does. Just get rid of "approved alternate" and you're back into the space of exemption requests that we typically are on this kind of -MS. HOLAHAN: Well, should we address the fact that licensees may come in to request, and that -- to propose an alternate, such as a physician under the supervision of, or a specially trained dosimetrist? MR. AYRES: My intent here was more with that statement as guidance to our license reviewers, who have been 199 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 document. provided -- who we -- who are the approved alternates through out technical assistance request and other correspondence. But since this goes to perspective licensees also, that could be confusing at that point. For the license reviewer, it makes more sense, because they know who we've approved. MEMBER QUILLEN: I'd take out the "approved alternate" and do what was suggested, which is say that the applicant can suggest alternate -MR. AYRES: The typical situation we run into where they request some relief is the facility which is very common that only has one medical physicist, and they don't want to suspend treatment when this individual is on vacation. MR. CAMPER: statement -MR. AYRES: MR. CAMPER: Yeah. -- is consistent, though, isn't it, Well, the approved alternate with the earlier point, which I do believe is made in the document, that under -- well, that was under PDR, though, we would consider an alternative. We have never, until this point, indicated that we would accept an alternative to -MR. AYRES: MR. CAMPER: MR. AYRES: MR. CAMPER: Right. -- the AU or the -Except in other documents. Right. I mean, I'm talking in this 200 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: MR. CAMPER: that's the next comment. In this document, that's correct. Well, I guess the -- and I guess I mean, should we? And then, the other comment is it seems to me that it's worthy of a couple of words being inserted that a physician working under the supervision of an authorized user, e.g. a resident, is acceptable. MR. AYRES: Well, in all of our other documents, we also say "with the specified device training." MS. HOLAHAN: But that goes without -- because that's up front, that anybody who is involved with it must have -MR. AYRES: But it says "the authorized user." It doesn't say "approved alternate" in that section, or anything like that. MR. CAMPER: Well, we've got to be careful about this, because clearly residents, I mean, can do this and should be able to do this. MS. HOLAHAN: MR. CAMPER: that, do you? CHAIRPERSON STITT: MR. CAMPER: MS. HOLAHAN: MR. CAMPER: So -And we can maybe just expand -We may need to do it in both places. No. No. Without having to come in here. I mean, you don't see a problem with 201 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 problem. MR. AYRES: dosimetrist. MR. CAMPER: Well, let me ask you this, then. What we have approved is a MS. HOLAHAN: MR. CAMPER: Right. To make it clear, I mean, specifically that residents who are operating under the supervision of an authorized user can do this, provided that they have obtained the device-specific training. really the issue, right? MS. HOLAHAN: MR. AYRES: approved alternate. Yes. Well, then, you give the one specific That's That's for an authorized user, you know. Well, the medical physicist is a MR. CAMPER: What would you do -- would you -- that raises an interesting question. If one looks at the requirements in 961 about the experience that's required to become a teletherapy physicist or a brachytherapy physicist, if you will, could a physicist in training during that one year -- could that physicist in training for that year function in the role of the medical physicist in this instance? Or could it be only an identified and approved physicist on the license? MS. HOLAHAN: MR. CAMPER: MS. HOLAHAN: Similar to the way a resident -Similar to the way a resident --- fill in as an authorized user. 202 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 thoughts? CHAIRPERSON STITT: It seems like it would work. MR. CAMPER: Yeah, right. What about that? Any I mean, is that -- the way things are written -MR. CAMPER: It's certainly treating -- it's treating a physicist in training in a parallel fashion to a physician in training. MS. HOLAHAN: That would still, though, probably wouldn't it have to come in on a case-by-case basis, though, still for an exemption, because whereas we have defined training and experience for authorized users and residents in training -MR. CAMPER: regulations? MS. HOLAHAN: We don't have defined regulation Do you mean defined it in the yet for a medical physicist, except for teletherapy physicist -MR. AYRES: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: Except our linkage to teletherapy -That's right. -- equivalent. So it's not quite as clean-cut as with the resident physician. MR. CAMPER: Well, that's certainly true. In pure regulatory-ese, you're right. imposing a regulatory requirement -- But certainly, we are 203 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MS. HOLAHAN: MR. CAMPER: Yes. -- via the current mechanism that we're using, because we're asking for specific things in guidance space, and then we're using -MS. HOLAHAN: MR. CAMPER: That's true. -- conditions. I mean, the net impact is a regulatory requirement. MR. AYRES: Yeah. And OGC is kind of dragging their heels on this one. MR. CAMPER: I'm not sure how it -You know what I'd like to do? I'd really like to explore that particular question with the ACMUI. Maybe we can add that as a squeeze-in agenda item. If we We'd have to notice it, though, wouldn't we, Torre? were to explore this one specific question, the concept of a physicist in training, while obtaining their experience as delineated in Part 35, to become a brachytherapy physicist -MS. TAYLOR: the Federal Register. MR. CAMPER: MS. TAYLOR: We can add -- we'll have to amend So I just need to know -Do we still have time to do that? We're past the 15 days. But with good reason, we can always do another one, and we'll need to put in a reason. MR. CAMPER: If we could do it, it would be nice to take advantage of the fact that the committee is going to be meeting very quickly, and I think we can address the issue 204 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in probably 20 minutes to half an hour. MS. HOLAHAN: Trish, I wasn't listening, if you would write the question out and get with me later. MS. TAYLOR: MR. CAMPER: explore it thoroughly. CHAIRPERSON STITT: physicists at that meeting. MS. HOLAHAN: Yeah, that's -- the only question Do we Except there won't be any Okay. That's a good way to make sure we is we don't have a physicist at the next ACMUI meeting. want to -MR. CAMPER: you're right. Well, we would have Dr. Wagner, but He's not the right type of physicist, yeah. Now, we're in an effort to reinstate the second physicist position, which may or may not be in place by the meeting next spring. Yeah, that's a good point. We probably -- well, we could certainly get a sense from the committee in terms of -- but it wouldn't be the same as having a physicist there. Well, for purposes now, let's ponder whether that makes sense or not. MS. HOLAHAN: Should we put in a statement at this point in time saying that licensees can propose alternatives on a case-by-case basis until we -MR. CAMPER: I think what I would do is, yeah, 205 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 number 8. try to capture a sentence in there that points out to them that physicians operating under the supervision of -- provided they have obtained the instrument-specific training, and so forth, and then see if you can't come up with a sentence that says, "Licensees may propose alternatives which will be evaluated on a case-by-case basis." That leaves the door open if someone wants to call us up and say, "Let me talk to you about this possible scenario." But that concept of a physicist in training, in parallel fashion to a physician in training, is something we ought to explore at some point with the committee. MS. HOLAHAN: I just wanted to make sure that, in my mind, that everybody here is comfortable with taking out the "or radiation safety officer." CHAIRPERSON STITT: MS. HOLAHAN: Okay. I am. Then, let me go back up to Should "radiation safety officer" then come out of If it's going to be the that last sentence in item 8? requirement -MR. AYRES: No, this one is more -- this one is intended to be more a review of the procedures, and I think the RSO is playing an appropriate role there. It's a commitment, a license commitment, that when -- says, "shall not commit any treatment with which a decoupling -- not removed -- decoupled or jammed source cannot be removed 206 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 It's -MS. HOLAHAN: MR. CAMPER: it's inside the patient. MEMBER QUILLEN: MR. AYRES: You've got a good point. I wasn't saying -Yeah, but I'm focusing on what -expeditiously in the patient, as determined by the authorized user with consultation." And the RSO has a responsibility in this area. This is like a preparation of the application. MS. HOLAHAN: Could I, then, propose that we say the RSO and medical physicist? MR. AYRES: MR. CAMPER: I'd say "and/or." Well, a question, Bob. In the case at hand, in item 8, when the source becomes decoupled or jammed, cannot be removed expeditiously from the patient. That's a medical issue. That's a pure medical problem. I mean, what is an RSO really going to do at that point? MS. HOLAHAN: there trying to -MR. AYRES: And placed in a shielded container. They may have the physicist in Well, I guess I was looking ahead that often the authorized user is not the author of the license application. As a matter of fact, I think more often the case than not he is not involved in preparing the license application. 207 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 it's -MR. CAMPER: MR. AYRES: Well, that's my point. It's a judgment or a -- we're asking MR. CAMPER: You know, you realize that this gets us back to that central question that we were exploring early in the game today under emergency procedure. CHAIRPERSON STITT: MR. CAMPER: Right. I mean, for example, if you were to -- if you took the statement and truncated it at the point -for the period after container, or for that matter after patient, I mean, that's -- that's really the question that we were dealing with this morning. explicitly? Do you state it that And we somewhat shied away from that explicit statement, as I recall, didn't we? MR. AYRES: Well, this is pretty explicit, but for a commitment from the licensee they won't do this, and that's -- that commitment is predicated on the judgment of the individuals involved. MS. HOLAHAN: In a way, this is almost saying that you must commit that if you're doing something that is going to require surgical intervention and you can't do it, then you're going to tell us that you won't do it. MR. CAMPER: MR. AYRES: Well, let me spend my -I'm saying, what the normal response is is they're saying it's going to be contained; and, 208 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 -MS. HOLAHAN: of the sentence? MR. CAMPER: Well, what I'm saying is if you read Oh, don't even have the last part then. therefore, there won't be a -MR. CAMPER: Let me spin my point differently, In the case at hand in item 8, we are soliciting a commitment from the licensee that it shall not conduct any treatment procedure for which a decoupled or jammed source cannot be removed expeditiously from the patient and placed in a shielded container. Now, then you can go on and on with whom this consultation is being derived. But is that statement to that point consistent with what we were saying under emergency procedures in item 11.21? CHAIRPERSON STITT: I thought it was. It's a different way of saying what we talked about earlier this morning. It really doesn't matter who you confer with. The statement stands as it is. MR. CAMPER: Put a period after "container." Well, what I'm getting at is we are that -- the emergency procedure, where it says, "If appropriate, supplies necessary to surgically remove applicator or sources from the patient, including scissors, capable cutters." Does that coincide with or work for the fact that you have previously, on page 27 under item 8, 209 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 technique. MR. CAMPER: stay with me. remove it. MR. AYRES: MR. CAMPER: Yeah. All right. Then, you go over there Okay. No, no, I understand. So it. MS. HOLAHAN: it surgically -MR. CAMPER: So now they've committed that they So if they can expeditiously remove can't -MS. HOLAHAN: MR. AYRES: Right. -- if they can't expeditiously remove solicited a commitment from the licensee that they will not do it? MS. HOLAHAN: MR. AYRES: No, because -No. It says they won't do it if they will expeditiously remove it. MR. AYRES: And then, this is going on on So they commit that they can expeditiously to your emergency procedures and you say, "If appropriate, supplies necessary to surgically remove." committed to doing it. MS. HOLAHAN: MR. AYRES: No. No. They may -You may have committed to not You've already doing the procedures which -- well, restricting yourself, 210 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 reviewers? MR. AYRES: MR. CAMPER: Well, I would certainly think so. Is it clear? which some have, to only doing those procedures which would not require surgical removal. MR. CAMPER: I know. But let's say they make the commitment, under item number 8, that they will not do it unless they can remove expeditiously from the patient and place it in a shielded container. that. MR. AYRES: surgical procedures. Right. Which may or may not involve Make a commitment to do If it's a -Okay. -- Fletcher suit, it's not going to, MR. CAMPER: MR. AYRES: or a tandem. MR. CAMPER: Well, let's say, for example, that they commit to doing it, and they commit to doing bronchial procedures. MS. HOLAHAN: MR. CAMPER: Then, they would have to -Then, under item F, on emergency procedures, we would expect to see, wouldn't we? MR. AYRES: MS. HOLAHAN: MR. AYRES: MR. CAMPER: Yeah, exactly. Then, it is appropriate. Then, it is appropriate. Well, is that clear to our 211 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 they? CHAIRPERSON STITT: MS. HOLAHAN: Say that again? You know, they would be MS. HOLAHAN: MR. CAMPER: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: I think it is. Okay. I mean -Yeah, I -Because I think if appropriate says if you're going to be doing things that you might need them, then, yes, you've got to have those. to, then you don't have to have those. MR. AYRES: MS. HOLAHAN: Yeah. But if you're not going If you're -- Someone -- -- you're not going to do those, then you don't have to have them. MR. AYRES: Some licensees have stated on their application that they were only going to do OB/GYN-type procedures or a select list that didn't involve anything that would require surgical, and then they didn't address these issues. MS. HOLAHAN: Templates are sutured in, aren't Templates. sutured in, wouldn't they? MR. AYRES: So that would -- Well, I don't know whether you define cutting a suture a surgical procedure or not, pulling a template out. I -It's possible that a needle CHAIRPERSON STITT: 212 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 could get stuck inside the patient or -- so you'd have to go after it surgically. MR. AYRES: Yeah. We had the case in, what, Keesler, where the needle got bent and -CHAIRPERSON STITT: I don't see the same problem. I am having somnolence from lunch, and you guys are on a high from it. But, to me, we're saying the same thing. My only problem with number 8 is that I don't know what the consultation with any of these people has to do with the fact you either commit to do the procedure or you commit not to do it. I don't -- I think that the consultation aspect of it is sort of fabrication. MS. HOLAHAN: after "container"? MEMBER QUILLEN: That's what I would -Yeah. I mean, I don't see So you would propose to end it CHAIRPERSON STITT: how consultation either before or after the license is written, or during a procedure, changes whether or not you've made this commitment that you can or cannot do X, Y, or Z procedures. MR. AYRES: Yeah, right. So I'm sort of looking at it CHAIRPERSON STITT: differently than -MR. AYRES: Okay. CHAIRPERSON STITT: But the three of you go 213 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 you did. (Laughter.) Are you happy yet? MR. AYRES: Okay. Eight? ahead, and we'll just take a nap and let us know when we're supposed to get -MR. AYRES: (Laughter.) CHAIRPERSON STITT: That's right. The rest of You didn't have the chili. Yeah, okay. Took care of 9. Trisha, you CHAIRPERSON STITT: were kind of going backwards. What else do we need to review that you caught that we need to smooth over? MS. HOLAHAN: I think you've addressed it by taking out those last two -- that last sentence, so it's gone, so -CHAIRPERSON STITT: All right. So points number 4, 5, 6, 7, 8, 9, are there any more issues, just on the two pages we have in front of us? MS. HOLAHAN: How about for you, Trish? I'm just going to raise a question And, I'm that was discussed yesterday in item number 3. sorry, I did tell you I wasn't going backwards. CHAIRPERSON STITT: MS. HOLAHAN: Where? Item number 3. Oh, I'm sorry, you can't CHAIRPERSON STITT: because I only said 4, 5, 6 -- 214 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 written? CHAIRPERSON STITT: to the way it's written? MS. HOLAHAN: The question that had come up What would be the alternative -MS. HOLAHAN: Or is it sufficient the way it is words. (Laughter.) All right. MS. HOLAHAN: Yesterday discussing, again, the radioactive module, and when we were discussing instructions for nursing personnel, the issue came up as to what instructions of the authorized user should we as a main -should we require nursing personnel to follow the authorized users instructions regarding care to be provided, medical care. Or is that another -- I mean, regarding care with respect to radiation safety aspects. MR. AYRES: MS. HOLAHAN: Oh, you went way back. Yeah, I'm sorry. Just say it again. Let me Oh, okay. CHAIRPERSON STITT: listen to it another time. MEMBER QUILLEN: You're qualifying care, in other You're trying to qualify it? MS. HOLAHAN: I'm asking, should we? Medical care, which is radiation MEMBER QUILLEN: yesterday was, should NRC be putting in their guidance that 215 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 too. the nursing personnel are required to follow the authorized users instructions, which would include medical care. CHAIRPERSON STITT: require medical care. MS. HOLAHAN: No. But the way it is written, I don't think the NRC can does this read as though it is only the care in terms of the radiation safety aspects? CHAIRPERSON STITT: MEMBER QUILLEN: Oh. That's the way I read it. That's the way I read it, CHAIRPERSON STITT: But then, it was kind of set up, because it's got RSO and because it's an NRC document. MEMBER QUILLEN: requiring -MS. HOLAHAN: Well, I'm not, and I just wanted to I didn't read it that you were make sure that that was clear. MR. AYRES: One of the things I had in mind here, of course, is the typical thing I would expect is where it says pulsed dose rate is care -- normal care should be restricted between the 30 minutes to the hour, if we -- which the authorized user would issue because that's when the sources would not be out. That sort of thing. Did yesterday's isotope group CHAIRPERSON STITT: want to see a change of any sort, or was it just an area they were discussing? 216 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 -MS. HOLAHAN: Okay. -- really relating to MS. HOLAHAN: They just -- it was just an area that they were discussing, in terms of the instructions when you're talking about following the instructions of the authorized user. We were clarifying it specific to the radiation safety aspects. CHAIRPERSON STITT: MS. HOLAHAN: Okay. Because they are also That's how I read it. CHAIRPERSON STITT: expected to follow medical orders that are written regarding -MS. HOLAHAN: Right. I guess I'd focus that it was CHAIRPERSON STITT: CHAIRPERSON STITT: radiation safety issues. MR. AYRES: I guess I took it that everybody -- most of us are taking that as implied. MS. HOLAHAN: MR. CAMPER: Okay. Can I raise something again? Can I take you back to page 27, item 8, again, for a moment? CHAIRPERSON STITT: MR. CAMPER: MS. HOLAHAN: That's forward. Oh, I'm sorry. Yeah, we jumped forward now. Better ask Trisha if she has CHAIRPERSON STITT: 217 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 spin. CHAIRPERSON STITT: MR. AYRES: Right. anything on 2 that she wants to -MR. CAMPER: We go forward from our last backward You are now on page 25, right? Well, but now -- CHAIRPERSON STITT: MS. HOLAHAN: MR. AYRES: MR. CAMPER: Now we're back up to 27. Now, we're back to 27? Okay. For item number 8, I'm still a little troubled by item number 8, and let me try to articulate it a little bit differently this time. In item number 8, I would prefer if there was some way to put a positive spin on it. As I read it now, you're asking a licensee to commit that Could you change it and they won't do certain procedures. say, "A commitment from the licensee that it shall only perform procedures" -MS. HOLAHAN: MR. CAMPER: Yes. -- "treatment procedures for which a decoupled or jammed source" -MS. HOLAHAN: MR. CAMPER: Can be --- "can be removed." And I think we'd make it a CHAIRPERSON STITT: lot more understandable as to what it was I was committing to do. MR. CAMPER: And the second part of that I would 218 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 then suggest, if you go over to page 34, item F, where it says, in the emergency procedures, "if appropriate." put a parenthetical "refer to" -MS. HOLAHAN: MR. CAMPER: whatever part this is. MS. HOLAHAN: MR. CAMPER: Right. Then, I think it's very clear to the You made a commitment back earlier Right. -- "commitment" in item 8 under I would licensee that, guess what? that you were only going to do procedures if, and this is where "if" comes to bear. MR. AYRES: MR. CAMPER: MR. AYRES: MR. CAMPER: Where are you at? I'm saying on page 27, item -No, I got that. Okay. Go over to the emergency Okay? Item F, page 34, Bob. procedures, item F, on page 34. MR. AYRES: MR. CAMPER: Okay. And the sentence in there where it says, "And, if appropriate," and I would parenthetically insert "refer to commitment of item 8" -MS. HOLAHAN: MR. CAMPER: MR. AYRES: MR. CAMPER: 11.201(b)(8). Right. I'm glad you -Very good. That's a special test they CHAIRPERSON STITT: 219 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 individual. MR. CAMPER: what it was. CHAIRPERSON STITT: All right. I like that. I He didn't have the chili. That's take before they -MR. CAMPER: And then, I think that the licensee, at that point, could put a positive spin on what they're committing to, and it's clear to them that, yeah, you'd better go back and look at what you said, because this is where surgical procedures come to bear. And I think it puts us in a pretty good comfort zone at that point. MEMBER QUILLEN: Yeah. I do, too. CHAIRPERSON STITT: MR. CAMPER: them do it, right? CHAIRPERSON STITT: Without causing -- without making I'm surprised you didn't catch that, because you're the -- this is actually a grammar, or not a grammar but an editorial construction sort of thing. MR. AYRES: Linkage. I get tired of being -The only responsible MEMBER QUILLEN: CHAIRPERSON STITT: think it makes -- and it relates those two, which is also very important, that all of this material relates to one another. Well, Trish, you have the option of going backwards or forwards. 220 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 well. MR. AYRES: MS. HOLAHAN: What about 11.20 now? Okay. Taking out those initial hoping. CHAIRPERSON STITT: MS. HOLAHAN: 11.201(b)(8) -MR. AYRES: MS. HOLAHAN: Whatever --- just a question, Bob. Under Okay? Okay. Because of the item MS. HOLAHAN: This is just a simplification, I'm that 11.20, can we not take out those initial numbers and just have that as a -MR. AYRES: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: knew that was backwards. MR. AYRES: Yes, it is. I haven't done my job very Where is 11.20 at? Page 24. Oh, that's back. I was afraid to say that, because I CHAIRPERSON STITT: numbers, because that could be a new paragraph just to say the licensee should provide a copy of operating procedures, again, I was trying to simplify the number of numbers that we have in here. MR. AYRES: MS. HOLAHAN: Oh, okay. Fine. And then, (a) and (b) could be -- 221 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that way. MS. HOLAHAN: That's right. I was wondering why it's page 28. MEMBER QUILLEN: Why is it that in this you go then. MS. HOLAHAN: Yeah, and the same thing for -- on stay as (a) and (b) and then -MR. AYRES: Well, they could be (1) and (2), 11.20, and then (1), but in your regulations you go 35.404, and (a)? MS. HOLAHAN: MR. CAMPER: guide format, right? MS. HOLAHAN: Well, I think partly as some of But we're taking out the (1). Well, I think the answer is it's this came from the P&GD, putting it into that format, whereas we have some of these 1's and 2's. guide format that we have numbers. CHAIRPERSON STITT: But you're right, it is I don't know why. Because it's made Because. MEMBER QUILLEN: inconsistent. That's all. MR. AYRES: Even more, it doesn't follow standard outlining format, which would be Roman numerals followed by capital letters, followed by -CHAIRPERSON STITT: I imagine there's a whole agency that knows about those things, though. 222 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 before. MR. CAMPER: Right. I hope you've got the comments I before. MR. AYRES: You could petition for rulemaking on MS. HOLAHAN: backwards now. Anyways, I've finished going I'm up to 27 again. Are you sure? You lied CHAIRPERSON STITT: changing the guide format. (Laughter.) CHAIRPERSON STITT: So let's just flip through from page 23, or wherever we -- we're probably up to 28, aren't we? MR. AYRES: We're somewhere around 28 or 29. We think that 23 to 28, 29 is CHAIRPERSON STITT: looking okay. MEMBER QUILLEN: 11 is the one I discussed MEMBER QUILLEN: had about -MR. CAMPER: Your operator device monitor. Certified -- MEMBER QUILLEN: MR. CAMPER: Right. Certified device monitor, So CHAIRPERSON STITT: which I thought was a gizmo, but I'm told was a person. we're going to -- how did we resolve that? MS. HOLAHAN: We're going to -- 223 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: throughout, aren't we? MR. AYRES: Well, yeah. It ran two things -We're supposed to make it consistent you're actually putting a certified with the wrong thing in a sense. We're required -- it goes back to the training for these, and under training it said that they should be both trained and certified -- in other words, tested. probably confusing on this, where it's used here. come it got in there. MS. HOLAHAN: Because actually, the reference to But it's That's how 9.1.1.3 refers them back to the training and certification. MR. AYRES: Training and certification, yeah. But it may be a little confusing -MR. CAMPER: this transcript? imagine? (Laughter.) I don't know if I could follow that 11.2.3(b). It does get cumbersome, doesn't it? CHAIRPERSON STITT: Is point 11 satisfactory with Could you imagine someone reading Someone reading this transcript, can you whatever changes, and what are the changes? MR. AYRES: Yeah, I will readdress it. You'll fix that for us? The way it CHAIRPERSON STITT: MR. AYRES: The intent was clear. came out isn't so clear. 224 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 11. CHAIRPERSON STITT: to fix that one up. All right. And with that one -I'll probably just get rid of the All right. So you're going MS. HOLAHAN: MR. AYRES: "trained and certified." MS. HOLAHAN: -- for the PDR, and that item 11, as we say "the medical physicist or radiation safety officer," is that what we're looking at? MR. AYRES: MS. HOLAHAN: MR. AYRES: Okay. Or is that going to -I got this decision right at the end, And, and I made the one change in the license conditions. yeah, radiation safety officer is history. MS. HOLAHAN: Okay. But for LDR, the radiation safety officer is acceptable, item 10. MR. AYRES: MS. HOLAHAN: MR. AYRES: Item 10 doesn't deal with LDR. Yes, it does. Oh, wait a minute. I'm reading item Where is item -- oh, yeah. CHAIRPERSON STITT: MR. AYRES: The one before. Item 10, it's Yeah, yeah, right. appropriate. MS. HOLAHAN: Okay. So we are allowing RSOs for CHAIRPERSON STITT: LDR but not for PDR. 225 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 checks. CHAIRPERSON STITT: remote afterloading. MEMBER QUILLEN: A couple of questions on 2, And we are discussing all consistent. MS. HOLAHAN: Or HDR. Or HDR, right. And all of CHAIRPERSON STITT: the folks that use those devices know that and have been through this discussion and practice. MR. AYRES: Yeah. Often, a radiation safety officer sets -- establishes the procedures sometimes in an LDR. MS. HOLAHAN: much for HDR and PDR? wouldn't it? CHAIRPERSON STITT: No. They don't have any -Right. But is that the case as It would be primarily the physicist, they basically have nothing to do with HDR and PDR. MS. HOLAHAN: Okay. All right. So we're CHAIRPERSON STITT: Thank you for catching those, though. All right. I think we're at the bottom of 28, and we're looking at 29. MR. AYRES: Yeah. It starts with the daily which starts on the bottom of page 28 and goes over to the top of page 30. It wasn't clear to me -- this is editorial again -- why you had a colon at the end of the paragraph on page 28. 226 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: Yeah, that's inconsistent. I should have semi-colons after all of the 1, 2, 3's, then, if I did that. I can get rid of the colon and make it a period. MEMBER QUILLEN: MR. AYRES: Okay. On -Some of It's a case of moving this. this was written from scratch, and others was imported from the policy and guidance directive, which left dangling artifacts. MEMBER QUILLEN: On the list of things you're supposed to be doing, as far as daily checks, at the end of number 5 it says you're supposed to keep a result of this test, with the initials. And then, in 7, it says again you're supposed to be keeping a record of these tests, with the initials. Either that's redundant or whether -- I'm not sure whether 7 applies to all of the above six or only -- which one. MR. CAMPER: Okay. Well, 7 -- right, 7 should be the catch-all for all of the above. MEMBER QUILLEN: was, but then -MR. CAMPER: Right. -- because you had -You're right. Yeah, that's what I thought it MEMBER QUILLEN: MR. CAMPER: MR. AYRES: MR. CAMPER: It is redundant. Yeah, I'll take care of that. So we should just strike it from 227 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 next? MEMBER QUILLEN: Next is item 3. The first comment. CHAIRPERSON STITT: MR. AYRES: I just kept going. (Laughter.) CHAIRPERSON STITT: Bob Quillen, what do you have Okay. item -MEMBER QUILLEN: MR. CAMPER: MR. AYRES: 5. -- 5, right. And as normally mentioned, normally -- or 7 will become not 7, but become a paragraph because it's a recordkeeping requirement as opposed to a test. MR. CAMPER: right. Right. That was my next MEMBER QUILLEN: I got so I like these numbers so much sentence says, "Prior to use, the following checks will be performed in accordance with the manufacturer's instructions within the preceding 30 days." MR. AYRES: Now -- Again, we'll get rid of the colon, I guess, and go to a period there. MEMBER QUILLEN: Well, it wasn't clear to me, prior to initial use, or prior to every use, or -CHAIRPERSON STITT: MEMBER QUILLEN: Is this acceptance testing? I wasn't clear Or what is it? 228 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 or will -MR. AYRES: Well, I was trying to do a little What I checks? MR. AYRES: Yes. Okay. Then, why don't you say awkward. as to what use we were talking about here. MR. AYRES: That prior use, yeah, makes it This is a 30-day -- the monthly checks, and -MEMBER QUILLEN: So are you talking about monthly MEMBER QUILLEN: something -- CHAIRPERSON STITT: Monthly checks will include, something different here, but it didn't work out well. was trying to say was that you need to do these checks every 30 days, if you're using a machine. CHAIRPERSON STITT: MR. CAMPER: Why don't you say that? Yeah, really. Seriously, it's very CHAIRPERSON STITT: straightforward, and then it's got some records that have to be kept and some lengths of time which end up in the other document that we're talking about. MR. CAMPER: And also, if you want it done every If 30 days, Bob, just say at intervals not to exceed 30 days. the device is used, at intervals not to exceed 30 days -MR. AYRES: MR. CAMPER: That needs a little work. -- then you shall do certain things. 229 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the field? MR. AYRES: Yeah, something, you know, looking -section? MS. HOLAHAN: Well, yeah, to have a subheading on checks. MEMBER QUILLEN: like you have -MR. AYRES: Yeah. That's a standard correction. And you need to separate (e) out Yeah, the intent was there is -- storage closet, no -CHAIRPERSON STITT: Number 4 is? MR. AYRES: Calibration. Calibration. Bob Quillen, So 3 has to do with monthly CHAIRPERSON STITT: what do you have to say about calibration? MR. AYRES: MS. HOLAHAN: subheadings under there? CHAIRPERSON STITT: Under the calibration I have some comments on that. Would it be clearer to have monthly checks, a subheading on calibration. CHAIRPERSON STITT: MS. HOLAHAN: Yeah. -- for the users to use. It would make it easier -- CHAIRPERSON STITT: You've got comments about the calibration from I can't remember who made it. CHAIRPERSON STITT: Dr. Quillen? Do you have anything, 230 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the -MR. AYRES: Oh, from Region 1, we should clarify We asked for MEMBER QUILLEN: I was trying to remember what who is authorized to perform calibrations. physicists to perform the calibration but imply that someone besides the physicist can calibrate the unit. That comes out of the teletherapy where the -- somebody else can perform the calibration, but the physicist has to review it. CHAIRPERSON STITT: MR. AYRES: So that's 4(a)? We should clearly Yeah, 4(a). specify if someone under the supervision of the physicist can calibrate the unit to be consistent with the requirements of teletherapy. We should require that the calibrations are performed by a medical physicist authorized on the license. One of the comments -- and I think maybe I missed -- I've got to go back. the commenter did. I don't think I missed it; I think But I think it's pretty clear here that a medical physicist has to be a named individual on the license. If it isn't, it should be. Yeah, but that comes under the fact that it's listed under authorized users, authorized RAL physicists. MS. HOLAHAN: MR. AYRES: Should be named on the license. For programs using HDR, PDR, RAL therapy and medical physicist experience, should be named on license. So it's there. They missed it in -- when they got 231 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in here. CHAIRPERSON STITT: -- to maintain, okay. That right? MS. HOLAHAN: Yes. I know what it was. was. MR. CAMPER: Okay. It's named on the license, over here in the calibration and said, "Well, gee, how about naming the physicist." MS. HOLAHAN: MR. AYRES: They are named. And they are named. I thought it MEMBER QUILLEN: Paragraph (c) doesn't have a verb in the first sentence. MR. AYRES: MS. HOLAHAN: MR. AYRES: Oh, yeah. Should be maintained. Shall be maintained, yeah. Shall include or will -Yeah, you can't put "shall" CHAIRPERSON STITT: MR. AYRES: Should. comes -- that goes under your list of required recordkeeping? MR. AYRES: If we do it, yeah. If we do it. CHAIRPERSON STITT: (Laughter.) MS. HOLAHAN: records of maintenance? MR. AYRES: Yeah. Well, actually, should that be CHAIRPERSON STITT: Records of maintenance 232 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 up. requirements. MS. HOLAHAN: Okay. On 4(a), do we want to -- CHAIRPERSON STITT: sentence 1 plus sentence 2? afterloading device sources? MR. AYRES: Or who can calibrate -- promote That was the issue that was brought What we do under teletherapy, we allow an individual under the supervision of the authorized physicist to perform the calculations. physicist. question. CHAIRPERSON STITT: MR. AYRES: Who is that likely to be? The authorized He is supervised by an authorized Should we or shouldn't we, I guess is the It could be anybody. physicist develops a calibration procedure and reviews the -MR. CAMPER: Well, you get back to this physicist in training, for example. MR. AYRES: MR. CAMPER: Or a dosimetrist or a technologist. Right, or a technologist, or the physicist himself, of course. MR. AYRES: MR. CAMPER: Yeah. Right. But one of the problems with Or the physicist himself, yes. CHAIRPERSON STITT: brachytherapy versus teletherapy is teletherapy is very stable as a rule. It should be. MR. CAMPER: Right. 233 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 now. have. MR. AYRES: Well, we also have two situations CHAIRPERSON STITT: And we're talking about I mean, sources that are coming and going here, potentially. this is a high dose rate iridium. I'm just a little -- I'm more reluctant to allow some of this to be done -MR. AYRES: MR. CAMPER: Well, we've now got two situations. So you're saying the second sentence should be explicit that only the physicist can do the -CHAIRPERSON STITT: That's a question that I We have the Farmer chamber type calibrations, which require more precision and care, and, of course, source to detector distances are very critical because of the lower strength of the source and the non-uniform field that you have with regard to teletherapy. On the other hand, a lot of facilities are going over to the small well ion chamber, which calibration almost becomes trivial except checking the math for the -CHAIRPERSON STITT: MR. AYRES: That's true. -- for those that are non-pressurized air chambers for the appropriate corrections for air density and temperature, etcetera. So you have one that's a real easy calibration procedure, technically, or at least in form you run the -- if you've got a proper jig, you program the source to go out to the middle of the chamber and take a reading, and 234 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that's it. The other one is -- requires more care. CHAIRPERSON STITT: So, I mean, in that sense, it reads perfectly well and is practiced that way. MR. AYRES: Yeah, by many -- more and more are going to the well chamber for these devices. CHAIRPERSON STITT: Well, and, of course, the issue is whether or not the authorized physicist checks their own work or somebody that they're supervising. If they don't check it, you're going to have a mistake like you -MR. AYRES: Well, they are required to --- the high dose rate And a It CHAIRPERSON STITT: prostate implant. I mean, that didn't get checked. regulation change wouldn't have made that any different. was a practice -MR. AYRES: Let me clarify here a little bit and make sure it actually -CHAIRPERSON STITT: So I think I'm satisfied with it, unless you folks feel strongly. Other issues under Section 4 about calibration? Bob Quillen, did you have other things on that section? other comments from the -MEMBER QUILLEN: I have to look at 30.59. -- outlying areas? Or CHAIRPERSON STITT: MR. AYRES: I recently on this dosimetry system and the AAPM certified lab calibration got a question, and my 235 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 on this. CHAIRPERSON STITT: calibration? On that section, for response was on that -- that they -- one manufacturer makes these well chambers as an integral unit. Electronics chamber It's and everything, it's all one -- like a dose calibrator. a black box. And they pointed out that this was extremely difficult and expensive to ship, and so on and so forth, because it was a whole package, and wanted exemption from the calibration every two years. But they had committed already to calibrating their Farmer chamber, which they use for this and other things, every two years. So I said, "No problem. You calibrate your Farmer chamber every two years, and you transfer the calibration to your well chamber." In other words, as soon as you get your calibrated Farmer chamber back, you calibrate your fresh HDR source, and then transfer that calibration to the ion chamber, and you've accomplished the same thing without sending the ion chamber. It's a transfer calibration to the AA -- ADCL is what they're called -- laboratory. MEMBER QUILLEN: I didn't have any more comments Does that bring us to 5, then, methods used for -- obtain compliance with -MR. AYRES: The requirement in -All right. CHAIRPERSON STITT: 236 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. AYRES: -- 10 CFR 59. Trish, anything you have from CHAIRPERSON STITT: here backwards? MS. HOLAHAN: Wow, I'm getting a reputation here. No, you're not. That's why CHAIRPERSON STITT: we work together on this. (Laughter.) MR. AYRES: (Laughter.) CHAIRPERSON STITT: truly reviewed. Brake or reverse shift lever. That way we know we have Everybody happy with it at this point, or are Because if there are some we willing to keep moving forward? other things that you are kind of sitting there dwelling on, we ought to review them. MR. CAMPER: Larry? No, I think I'm okay. Bob Quillen? CHAIRPERSON STITT: MEMBER QUILLEN: I'm okay. All right. That brings us to CHAIRPERSON STITT: emergency procedures, which I think I've heard about before. MR. CAMPER: Yes, I think we have. Do you think we've had enough CHAIRPERSON STITT: emergency procedures? MR. CAMPER: I think so. Okay. Maintenance. CHAIRPERSON STITT: Maintenance of remote afterloading. 237 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 old. MR. CAMPER: But even there, I think I would make MEMBER QUILLEN: maintenance. CHAIRPERSON STITT: MEMBER QUILLEN: Yes, sir. I have a question on It's more how the NRC does things, which is do you require or expect that a person performing maintenance on these devices do a reciprocity request when they go into another jurisdiction? MR. AYRES: MR. CAMPER: Definitely. Sure. We had to tell Nucletron that MEMBER QUILLEN: they had to do that, because they weren't doing it. MR. AYRES: They got a civil penalty for not doing it in our -- they are now licensed. MR. CAMPER: discuss names. MR. AYRES: MR. CAMPER: ongoing action. MR. AYRES: This is not. This is several years Oh, okay. Particularly if there is some Be careful to the degree to which we that point without referencing any -MR. AYRES: Since it was public document I -- but yeah, they now handle -- one way of handling it is to become licensed in the state, or the other way is to do reciprocity. 238 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 And if a company does a lot of repair work, it's probably to their advantage to get licensed in the location where they do the repair work rather than -MR. CAMPER: But this point, though, that I think that Bob is getting at is the point that I raised yesterday when we were talking about mobile nuclear medicine, and that is yesterday I wanted to have some words put in that reminded people in doing mobile nuclear medicine, if you're crossing out of NRC jurisdiction, going into an agreement state, then there is the question of reciprocity, and do we need to contact the agreement state, because the reciprocity requirements vary from state to state. And imagine a scenario where you have an NRC license, and you're operating from southern Virginia, and you want to go across the border into North Carolina. just do that. Well, similarly, it might be worthy if we could find some words to put in here to point out that reciprocity may be a consideration when using companies for purposes of calibration, and that there is a need to ensure that reciprocity requirements, as they relate specifically to the states involved, are met. MS. HOLAHAN: But is that incumbent on the You can't licensee or the manufacturer? MR. CAMPER: Well, it's incumbent upon the 239 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is. MR. AYRES: Well, I guess the only problem there servicer, the company. MR. AYRES: Actually, there is three scenarios -- agreement state, one agreement state into another, from an NRC state into agreement state, and from an agreement state into an NRC state. There is all -Well, I -- but, you know, it does -- MR. CAMPER: certainly, the responsibility for the reciprocity is with the service organization. MR. AYRES: MR. CAMPER: least be aware -CHAIRPERSON STITT: MR. CAMPER: Should be aware, right. I guess the question is, should -Should the licensee check -Well, or should the licensee at -- that reciprocity, when you're dealing with companies that are calibrating or, excuse me, doing maintenance on your remote afterloading device, you know, you probably would be wanting one that has gone through -MEMBER QUILLEN: MR. CAMPER: Right. -- whatever appropriate reciprocity there isn't an incentive or disincentive, and there is no penalty accrued to the licensee if repair is being done by a maintenance or vendor organization that doesn't have reciprocity. The -- 240 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the -MR. CAMPER: Or an agreement state, and then the MR. CAMPER: Actually, no. Well, no, but wait a second. The licensee shall confirm that only personnel who are licensed by the Commission or an agreement state to perform such services will perform maintenance. MR. AYRES: with reciprocity. MR. CAMPER: absolutely, it does. Well, certainly, it does. No, You -- But that doesn't have anything to do I would submit to you that if you're an NRC licensee in an NRC state, and you're using a company that's licensed by an agreement state, and reciprocity has not occurred as required under 150.20, that company is not licensed by the Commission in that case to do it. MR. AYRES: Yeah. You're getting to a point that process involves reciprocity. MR. AYRES: The way the situation is now you go read any vendor or service organization license, and you'll see that they are licensed to service machine X, Y, A, B, C, or what have you, which as I read this would satisfy that requirement. Now, I admit that the company hasn't satisfied their own requirement if they don't apply for reciprocity. Right now, in any case I'm aware of, the fault is attributed to the service organization, never to the licensee. 241 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that. MR. AYRES: MR. CAMPER: MR. AYRES: MR. CAMPER: MR. AYRES: MR. CAMPER: -- require reciprocity. And then, this is -I'm just saying -It's an informational point. Yeah. The licensee should -- is there any MR. CAMPER: Well, there is no question about value, or is it appropriate for licensees to be aware that when dealing with organizations that are licensed by the Commission agreement state, and are crossing state lines, that there is a reciprocity process involved? value in them knowing that? MEMBER QUILLEN: in an agreement state. See, here's the problem we face I mean, is there any I have -- company A comes in from another agreement state, or from the NRC, for that matter, and does maintenance. They leave. licensee. I don't have jurisdiction over that company that came in under reciprocity once they're gone, because I have no jurisdiction outside my state -MR. AYRES: I guess that's where we differ -Yeah. They have not filed a reciprocity with me. The only person I have jurisdiction over is the MEMBER QUILLEN: MR. AYRES: -- with you. 242 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 hassle. MEMBER QUILLEN: Oh, well, we would hassle the wouldn't. MEMBER QUILLEN: I mean, it's going to cost them correct. issue. it. MEMBER QUILLEN: And I can't do anything about The only thing I can do is go hassle my licensee at the -- you used a company that was -MR. AYRES: This sounds like a much broader It sounds like it deals more like a problem with 150 What we're trying to do is -- it part than it does here. sounds to me -MR. CAMPER: I agree. Well, as you know -- you are We have a memo with research to do a revision to 150. MR. AYRES: But it -- reminding licensee that their service organization should do something, which if they don't bother to check, isn't going to cost them anything anyway. It probably would not be too -MEMBER QUILLEN: because it's going to -MR. AYRES: Okay. I guess in our states, it Well, it is going to cost them, that we're going to hassle them. MR. AYRES: Well, they're the only people we can vendor or the service organization. MR. AYRES: Well, yes, but the vendor was in an 243 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 authority. in 150. MS. HOLAHAN: here just saying that -MR. AYRES: I guess you always do have some So do we want to put a statement in agreement state. How are you going to hassle them then? We have that provision in our -- MEMBER QUILLEN: You can always bar the vendor from -- an individual agreement state could take some sort of regulatory action to bar the vendor from working in the state, or assess a civil penalty that they can't work in the state again until they pay. authority. CHAIRPERSON STITT: Is it appropriate to put a I would think you would have some sort of helpful tip in this section of an NRC document on a -MS. HOLAHAN: Where we remind the licensee that it's the vendor's responsibility, but the vendor would -MR. CAMPER: Well, if we were going to do something about it, in terms of information, it would be something along the lines of a sentence that said, in essence, the following. If we have a sentence that says, "The licensee should confirm that only persons who are licensed by the Commission or agreement state to perform such services," blah, blah, blah. Please note that a service company licensed by -remember now, we're talking NRC licensees -- licensed by an 244 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Trisha? MS. HOLAHAN: No. Okay. agreement state will be required to file for reciprocity within -- by -- with the NRC in order to perform this service. CHAIRPERSON STITT: MEMBER QUILLEN: Bob Quillen, is that helpful? Yes. Let's put that in. It's easy CHAIRPERSON STITT: to read, it's a helpful hint, and there is no paper that has to be kept for three years. MEMBER QUILLEN: Right. We've done them a favor. Bob, what else do CHAIRPERSON STITT: Let's keep going with maintenance. you have? MEMBER QUILLEN: That's all I have. Are you sure? CHAIRPERSON STITT: MEMBER QUILLEN: That was my last item. Okay. Trisha? CHAIRPERSON STITT: MEMBER QUILLEN: I had one grammatical thing. One grammatical thing. One CHAIRPERSON STITT: editorial comment? All right. MEMBER QUILLEN: the next page. Under waste management, which is Go up to 12 -- let me -No, I'm not going to let you CHAIRPERSON STITT: go on to 12, not yet. Save it. Any other issues on maintenance, Section 11? 245 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 management. MEMBER QUILLEN: Okay. My comment on radioactive else? MR. CAMPER: Nothing here. Okay. 12, radioactive waste which -MR. AYRES: This is the one we did, 11.22.1. 1, okay, all right. Anything here. MR. AYRES: Yeah. One of the items is buried in It also arose out of the mobile I'll just mention it. unit is -- is the source replacement issue, and in here is a requirement that they -- it either be done by the vendor or somebody certified -- trained and certified by the vendor to do those source exchanges. CHAIRPERSON STITT: Which section is that, or CHAIRPERSON STITT: CHAIRPERSON STITT: waste management is that what you're referring to here is not -- it's unclear because you've got two situations. You've got a situation you're talking about where you're returning material to the vendor, which I think is the typical situation. MR. AYRES: The normal, yeah. Okay? Which is not radioactive MEMBER QUILLEN: waste management. The second situation is where the licensee So you're mixing two actually does dispose of the sources. different situations here. 246 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 then? therapy. MS. HOLAHAN: So we'll be discussing it tomorrow. Radioactive waste management, right. CHAIRPERSON STITT: How did this come up in Do they return sources, or Now, in the first situation where you're returning the material to the vendor, it has been my experience the vendor comes in, packages the material in their shipping container, and then does the paperwork while the licensee sort of stands by the sidelines and watches. MR. AYRES: Some do and some provide the container with instructions. MEMBER QUILLEN: MR. CAMPER: Yeah. Well -- Is anybody getting rid of the And, if so, why would they? Other than what? sources, other than that way? CHAIRPERSON STITT: MR. CAMPER: Returning it to the vendor. Iridium-192 we returned, not How CHAIRPERSON STITT: the high dose rate sources, but LDR sources we returned. did this -MR. CAMPER: You return them to the vendor, regard to yesterday's discussion? do they use them up and just -MR. CAMPER: Yesterday was radiopharmaceutical CHAIRPERSON STITT: 247 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 more -CHAIRPERSON STITT: Bob Quillen's point about is all liquid. MR. AYRES: And you can see this is 12.3. 12.1 MR. CAMPER: We'll discuss it tomorrow. But it's and 2, obviously, deal with the other more normal disposal method. MS. HOLAHAN: In the Reg. Guide -- you see, the item is listed the way the license application is listed. Item 12 is considered waste management, which is, you know -CHAIRPERSON STITT: MS. HOLAHAN: So do you -- -- disposal of sources would be waste management returning sources to vendors, or is that -MR. AYRES: That's one form of -Is it? CHAIRPERSON STITT: MR. AYRES: -- managing the waste disposal. The transfer is not a waste MEMBER QUILLEN: disposal, because if you do ship it as waste, it becomes waste. But if you ship it back to the manufacturer, it is It's a very crucial point in waste management still material. that -- MR. CAMPER: Yeah. And my point was that I would be surprised if anybody is doing anything but that. MR. AYRES: MR. CAMPER: For these type of sources, yeah. What? 248 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 10.8. MR. CAMPER: Yeah, 10.8. Okay. Section 12. MR. CAMPER: MS. HOLAHAN: MR. CAMPER: MS. HOLAHAN: Well, where are the words for that? For what? This is in -This is in the body of Reg. Guide MR. AYRES: MR. CAMPER: MS. HOLAHAN: found there are returned. CHAIRPERSON STITT: So do we just -- is our Radioactive waste For these type of sources. Exactly. Because even the cesium sources problem here the label isn't quite right? management is not the label we want? sources. MR. AYRES: Item 12 is returning Well, I think this is a broader question for 10.8, because I think that's the number for 10 -MS. HOLAHAN: You see, it's -- the title relates Now, the to the Form 313 on your license application. question is, where else would you address it if it was not waste management, because it is returning sources? why we created a separate category. waste disposal. And that's As Bob mentioned, 12.1 is And Yeah, 12.2 is other waste disposal. then, 12.3 is returning sources. CHAIRPERSON STITT: Okay. So it's just under the 249 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 well, okay. sources -MS. HOLAHAN: MR. CAMPER: More than one -Oh, no, I understand that. But what MS. HOLAHAN: And that's why -- and then, if you look at the actual Form 313, which you submit with your license, this item is classified as waste management. MR. AYRES: but it's making -MR. CAMPER: MR. AYRES: square hole. MS. HOLAHAN: MR. CAMPER: Right. Well, another question on that, what "Most RAL brachytherapy Right. -- putting a slightly round peg in a Yeah, it isn't exactly a perfect fit, do you mean by the first sentence? sources are reused for therapy," what does that mean? MR. AYRES: MR. CAMPER: reused for therapy? MR. AYRES: Well, mobile treatments or before the Well, there are some that aren't. Well, what do you mean, they are does that have to do with the returning sources? MR. AYRES: It just says that they aren't -- It says unlike other -- an example where it isn't would be the Nucletron low dose unit, where they custom cut iridium ribbons and load them into a safe for remote afterloading. 250 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 reasons. sources -MR. CAMPER: MR. AYRES: wouldn't hurt anything. MR. CAMPER: -- is reached, or when the useful When the useful source -You could delete that sentence. It MR. CAMPER: MR. AYRES: sources are replaced. MR. CAMPER: MR. AYRES: MR. CAMPER: Right. That's a one-shot deal and then the They're custom assembled for -No, I understand. They're iridium seeds. No, no, I understand that. But the category is returning sources. CHAIRPERSON STITT: Well, you could just say when life of the source is reached, it will be necessary to replace it, and they should be returned to the vendor or other authorized recipient. MR. AYRES: I guess a source expires for three It is It's permanently implanted, which is obvious. customized, such as an iridium ribbon that is ordered and cut to length for a particular one-time treatment. MR. CAMPER: MR. AYRES: MR. CAMPER: MR. AYRES: Right. And/or its half-life. Right. I mean, there is three reasons for replacing a brachytherapy source. 251 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MR. CAMPER: through its decay cycle. MR. AYRES: Yeah. That's one of the -- I mean, The third is just -- it has gone the first sentence doesn't really add anything. MR. CAMPER: mean, I think it -MR. AYRES: MR. CAMPER: Yeah. -- it isn't wrong, but it isn't -You could say when remote I don't think it does either. I CHAIRPERSON STITT: afterloading brachytherapy sources are replaced, they should be returned to the vendor or other authorized recipient. MS. HOLAHAN: I think, too, is this was -- again, we were trying to keep modules consistent, and the manual brachytherapy may need to be changed when we discuss it tomorrow. MR. AYRES: MS. HOLAHAN: MR. AYRES: MS. HOLAHAN: be reused for therapy. Yeah. It starts off saying -About the same thing. -- many brachytherapy sources may Whenever possible, used sources that will not be reused should be returned to the vendor for disposal. facility. As opposed to indefinite storage at licensee's So that's, you know -MR. AYRES: things in similar -That's a little bit of trying to keep 252 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 MS. HOLAHAN: in that one? CHAIRPERSON STITT: those lining up? Items 1, 2, 3, 4, and 5, are Packaging, Yeah. So -- and, again, why is it Is everybody happy with those? Bob Quillen? surveys, labeling, etcetera. MEMBER QUILLEN: licensing guide. I'd have to go back to the But, obviously, all of these things that refer back to 49 CFR -MR. AYRES: Yes. -- and so what you're doing is MEMBER QUILLEN: saying, in accordance with 49 CFR, you want to assure that you do these -MR. AYRES: MR. CAMPER: MR. AYRES: And/or 10 CFR 171 or -No. Isn't it CFR 170? Isn't it? Yeah, 170. I should refer to -- CHAIRPERSON STITT: that section? folks? MR. CAMPER: Item 12? Are there any more issues on Are you ready to go to the glossary, Yeah, that's all I have. I looked at the glossary. CHAIRPERSON STITT: Who wants to complain about the glossary? (Laughter.) MR. CAMPER: Who wants to complain? I mean, I've been through it. It's brief. It's to the CHAIRPERSON STITT: I think it's helpful. It's fine. 253 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 point. MR. CAMPER: There's a couple of terms that we've discussed today that should be added, aren't there? CHAIRPERSON STITT: MEMBER QUILLEN: only comment. CHAIRPERSON STITT: MR. AYRES: And what are those terms? Yes, that's right. That's my Yeah, that's right. I had one comment here that -- on interluminal -- maybe suggest an additional definition as with the inner space of a tubular organ. But in lumen, it -- lumen of a tube is sort of a gratuitous definition, I guess. MS. HOLAHAN: MR. CAMPER: medical physicist? MR. AYRES: MR. CAMPER: MR. AYRES: MS. HOLAHAN: MR. CAMPER: Certified by whom? MR. AYRES: By the definition in this document. But if we can define it in Yeah, that -Were you going to put in operator? Certified or -Do we want to have certified -What does "certified" mean? I think it came out of Steadman's. Well, were you going to put in CHAIRPERSON STITT: that document. MS. HOLAHAN: MR. AYRES: But do we need to put that -I look at that issue and -- 254 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 away, yeah. CHAIRPERSON STITT: It's a catch-phrase that that. MS. HOLAHAN: For the purpose of the glossary, in -MR. AYRES: Yeah, they've got to keep records of certified? tested -MR. AYRES: A written and practical test MS. HOLAHAN: MR. CAMPER: Yeah. What does one need to do to become Demonstrate competence, and certification is demonstrating competence in the -CHAIRPERSON STITT: MR. AYRES: MR. CAMPER: does it say that? MR. AYRES: MS. HOLAHAN: MR. CAMPER: It's in the training. Bob, for the purposes of -Is that a matter of record, though, Does it say that? Yes, it does. Where do you get all of that? Where though, could we define device monitor and device operator? And then, in the training we would say that they would need to be trained and certified, rather than calling them a certified device monitor. MR. AYRES: Yeah. I think the certified may go brings up a lot of bells that we'd have to support, and we 255 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 can't. And I think it would just be easiest to leave it. MS. HOLAHAN: The only term I think might be difficult to define here is medical physicist, because we're going to define medical physicist as it applies to this module. MR. CAMPER: Well, the definitions are always -- the definitions here would be germane to this module. MS. HOLAHAN: Right. But then the question is -- because the comment is also being raised, do we define a medical physicist when we use the term in -MR. AYRES: in the training. Yeah. I don't really use "certified" I say, "Upon completion of this training, competence should be demonstrated by both practical and written examinations." CHAIRPERSON STITT: But there was a phrase in there that -- at one point, that Quillen found that said certified device operator. MR. AYRES: Well, yeah, I read that. We need to strike the CHAIRPERSON STITT: "certified" in that. MR. AYRES: Yeah. Got to get rid of that. It relates back to this, and I just called it certified competence demonstration. MS. HOLAHAN: think should be included? Wrong way to go. Okay. Are there any other terms that you 256 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 new? MEMBER QUILLEN: None that I have. I don't remember reading CHAIRPERSON STITT: through anything that was out of -MR. CAMPER: No. I think those are the ones that we've stirred up along the way. MEMBER QUILLEN: Yeah, I think we should have W- I-R-E, O-R underlined, hyphen E-D. CHAIRPERSON STITT: MR. AYRES: Where are you, Dr. Quillen? I -- Oh, I'm going to readjust that. that wired or/wired and. MEMBER QUILLEN: MR. AYRES: For us non-electrical engineers. I will rephrase that, those two. I'll just say logical or/logical and. CHAIRPERSON STITT: brachytherapy glossary? Okay. Now, the standard license conditions. Yeah, I guess it is, isn't it? Is this Yes? Okay. No? Other comments on the Everybody happy with that? We put things together -- pulsed, medium, high dose rate -- so we need to review these pages like the others or -MS. HOLAHAN: MR. AYRES: These were what -We bounced into and out of them as we went through the document already. MS. HOLAHAN: MR. AYRES: Right. We certainly discussed this source 257 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 text. MR. AYRES: MS. HOLAHAN: Yeah, I -Standard and sample. inventory one, I think, quite a bit. CHAIRPERSON STITT: How about the first sentence? Is that all right in Is this -- can we use the term "always"? this case? We can use that term? MS. HOLAHAN: They don't apply to anything other than remote afterloading devices. MR. AYRES: Right. Only apply to the use of -- CHAIRPERSON STITT: are we going to get grief over always, shall, should? MS. HOLAHAN: apply to all. Is that -Right. I have them generally apply Yeah, because some of them don't MR. AYRES: to all, pulsed, and medium, and high. MR. CAMPER: MS. HOLAHAN: Yeah, he has segregated them by -Do we need the word "always"? Can we just say, "The following license conditions apply to use"? MR. AYRES: wonder if -MR. CAMPER: MR. AYRES: I'd strike "always." Should I get rid of "standard"? I It's probably a little over it. I refer to them in the text as sample. MS. HOLAHAN: You've got them both ways in the 258 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is, huh? MEMBER QUILLEN: Let's see, this says, "The MR. AYRES: Yeah. Need to be consistent. I don't know which way to -MR. CAMPER: MR. AYRES: MR. CAMPER: MR. AYRES: Well, standard is our -Okay. -- nomenclature. That's what I -Okay. CHAIRPERSON STITT: MEMBER QUILLEN: bottom of page 39. CHAIRPERSON STITT: MEMBER QUILLEN: I have a comment on (b) at the Okay. You refer to item 9 sub-items. You're wondering where that CHAIRPERSON STITT: following shall" -- I would opt for putting them in, all of them, so that they can -MS. HOLAHAN: MR. AYRES: care of that. And then we do -- we would be -Okay. If that's the case, I'll take That will come out of -- that one I missed that That's came out of the old policy and guidance directives. item 9. MS. HOLAHAN: Which one was that? CHAIRPERSON STITT: listed in item 9. MR. CAMPER: Paragraph (b), page 39, Let me ask the group a question. 259 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Trish and I were having a sideline discussion here. You're saying in this case now, on page 39 and 40, you're saying standard license conditions that are being used for RAL, for brachytherapy, okay? Now, the other modalities, the other issues for which we also developed modules also carry with them certain standard conditions. Those other modules, unlike this one, do They not have in them, at the end, those standard conditions. are in this particular one because, again, this is part of this fallout that I alluded to earlier today, in that we had been doing a lot of the current level of regulation of HDRs through license conditions, just as time as we modernized the regulations, if you will. Now, the question really is, a) what is your impression of having the standard license conditions included in the guidance document? Do you think that is of utility to Or could it be jettisoned? the licensee, to the applicant? Or -- and secondly, if we do keep it in this one, if we think it has value, should we be putting standard license conditions that apply to the other modalities in those guidance documents as well? Do you have any impressions about that? MR. AYRES: One thing I mentioned that -- that part of the reason, too, is we needed a lot of these "in lieu of's" -MR. CAMPER: Right. 260 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 here. conditions. CHAIRPERSON STITT: referring to? MR. AYRES: Because we had to provide an Say that again. What are you MR. AYRES: -- type of standard license alternative to the current regulations that didn't -- for manual brachytherapy for -- that just can't be applied to a remote afterloading device. MEMBER QUILLEN: Well, I liked having them in The only thing that -- I was confused for a while, and it just dawned on me why I was confused, and that was that page 39 and 41 are in different print than pages 40 and 42. (Laughter.) And part of -- and when you printed it, part of it got carried over to one page, so -CHAIRPERSON STITT: Somebody summarize for me what this is, because all of the points here are in the larger document. So it's a distillation of the essence that the -MS. HOLAHAN: on the license. No, these are actually what get put When you come in and you get an approved license, then attached to your license are all of these conditions that you have committed to. you're going to do." CHAIRPERSON STITT: And then, the body that we It says, "This is what just went through is a discussion in more detail of some of 261 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the conditions -MS. HOLAHAN: That's correct. -- or how you reach -In the body, sometimes I just CHAIRPERSON STITT: MR. AYRES: Yeah. referred to these standard licenses. CHAIRPERSON STITT: So in that sense, I think it would be very helpful, because it's a place where you start, and then, like Trisha, work backwards. (Laughter.) MS. HOLAHAN: And I guess, then, the question is, Should -- this goes back to your If we're going to include it would that then be helpful? consistency question of modules. in one, should we include them in -CHAIRPERSON STITT: MS. HOLAHAN: Well, I think so. Now, this list -- all of them? would be expanded, because there would be more conditions that we don't have in here yet. MR. AYRES: MS. HOLAHAN: It may. Yeah, I think so. Again, as I mentioned, the one that comes to mind is the physical presence of the physician and the authorized user. That would become a license condition. The thing I'm struck by when I think MR. CAMPER: about it is if I kind of look at this across the board, I would think that there is value in an applicant seeing in front of them the kinds of conditions that will ultimately be 262 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 imposed upon them in their license as a result of their application and the commitments they are making, whether it's for, in this case, RALs, for that medical use at large in the medical licensing guide. Is there some value in, again, seeing the conditions that will ultimately be imposed upon your license? MEMBER QUILLEN: MR. CAMPER: I think it would. Would that help you better understand what the licensing process is all about? CHAIRPERSON STITT: through that process. MR. CAMPER: Because, you know, there are those Exactly. And how to go who say the licensees don't do a terrible good job of reading their licenses once they get them. But they, in theory, you would think, would be looking to a guidance document as they're applying to get it and trying to submit the right kinds of things. MS. HOLAHAN: That's one thing that I wanted to add, too, is in developing these modules, previously what had happened is the Reg. Guides that went out to licensees contained certain information. Then, we had what was called a standard review plan for license reviewers that would often include reviewers' notes. Well, as part of this overall module effort, it came to our attention that often those reviewers' notes were 263 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 lending. also helpful to licensees, and so what we have done now is this would be the document that would be used by both the licensees and the licensing reviewer. So we have included anything that previously might have been considered a reviewer note into the body of the module. And then, the only thing that the reviewers would have additional would be a checklist as they would go down looking at a license application. MR. AYRES: And perhaps related technical assistance requests, the sort of thing that come after the document. MS. HOLAHAN: That's right. But it wouldn't come -- I mean, not as they would use as the body, but that's one of the things we have tried to do is incorporate many of the reviewers' notes in so that everybody is working, knows where everybody is. MR. CAMPER: You know, the idea is that truth-in- You know, if our reviewers need to see that, why shouldn't applicants be aware that the reviewers are seeing that and focusing upon it? reasonable approach. MEMBER QUILLEN: I wasn't here for your And that's a legitimate and discussions yesterday, but I certainly would think that they should have access to that. MR. CAMPER: Yeah, I think that makes sense also. 264 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in -MS. HOLAHAN: MR. AYRES: (Laughter.) That has already been duly noted in -MS. HOLAHAN: Oh, okay. What other business do we Okay. -- importing this stuff over from -MS. HOLAHAN: Just as a note, we can pull out the old Part 20 references on the -MR. AYRES: Oh, I already noted that. That was CHAIRPERSON STITT: want to do today? MR. AYRES: MS. TAYLOR: MR. CAMPER: That's all for today. That's all we can do today. That's all we do today, because the schedule for the other topics are in the -CHAIRPERSON STITT: Tomorrow we'll do manual brachytherapy, teletherapy, and gamma -- same fashion that we worked today. MS. HOLAHAN: A lot of the issues that we discussed in remote are also applicable to manual, so hopefully some of those won't take quite as long. MR. AYRES: Actually, we did this review the Manual was written reverse of the way they were written. before -MS. HOLAHAN: That's true. We wrote manual, and 265 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 day, then? then we wrote remote. CHAIRPERSON STITT: Well, the remote is the harder of the whole group, isn't it? MR. CAMPER: I think so. I would think so. CHAIRPERSON STITT: MR. AYRES: It's certainly more complex, I guess, because of the multitude of different types of devices. CHAIRPERSON STITT: So we'll start off with manual first thing in the morning. MR. AYRES: MR. CAMPER: That's it. (Whereupon, at 2:55 p.m., the subcommittee meeting was concluded.) Okay. Okay. That will work. Are we in closure for the