Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Advisory Committee on Medical Uses of Isotopes: Subcommittee on Mobile Medical Service: Morning Session
Docket Number:
(not applicable)
Location: Rockville, Maryland
Date:
Wednesday, September 27, 1995
Work Order No.:
NRC-339
Pages 1-176
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 BARRY A. SIEGEL LOUIS WAGNER MEMBERS PRESENT: UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION + + + + + ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) + + + + + SUBCOMMITTEE ON MOBILE MEDICAL SERVICE + + + + + MORNING SESSION + + + + + WEDNESDAY SEPTEMBER 27, 1995 + + + + + ROCKVILLE, MARYLAND + + + + + The Subcommittee met at the Nuclear Regulatory Commission, Two White Flint North, 11565 Rockville Pike, Room T2B1, at 8:00 a.m., Barry A. Siegel, 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 25 TORRE TAYLOR JAMES LYNCH LARRY CAMPER JANET SCHLUETER MARGO BARRON GARY STEIN ALSO PRESENT:
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 A G E N D A Agenda Item Addresses Where Licensed Material Will be Used or Possessed Location of Use . . . . . . . . . . . . . . . Base Hot Lab . . . . . . . . . . . . . . . . 29 76 100 113 Page
Temporary Job Sites . . . . . . . . . . . . . Radioactive Material and Purpose . . . . . . . . .
Individuals Responsible for the Radiation Safety Program Emergency Procedures Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 148 154 171
. . . . . . . . . . . . . . . . . . . . . . . . . . .
Overnight Storage in Mobile Vans
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 (8:19 a.m.) I'm Larry Camper.
I'm the chief of the Medical Academic and Commercial Use Safety Branch. meeting. I'm the designated federal official for this
The purpose of the meeting for the next two to three
days, which were publicly noticed, is to discuss a number of draft modules for inclusion into the existing Regulatory Guide 10.8, which is the Medical Licensing Guide. is part of an updating to Reg Guide 10.8. This effort
The agency
recognizes that ultimately Reg Guide 10.8 will undergo a substantial change as we move in the future to revise Part 35, following the receipt of the report by the National Academy of Science. However, the reason we're updating the guide at this
point in time to the extent that we are is that over the last couple of years we've been working under a plan known as the Medical Management Plan. Janet Schlueter, who's in the
audience, is a member of my staff, is the project manager for the MMP. And there was some guidance lacking in Reg Some of it was lacking in its entirety and some
Guide 10.8.
of it was lacking in part and needs to be updated. So what we're going to accomplish over the next two or three days with the assistance of the subcommittee is to take a look at these draft modules, and then ultimately these draft modules will be published and will be included in
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 10.8. Janet, what's the schedule and where do we go from this point forward? MS. SCHLUETER: Okay. Just to kind of give you
an overview of where we are in this entire project, there are seven different working jobs and I'm the chair of this project. And what we did is we developed those last summer
and fall, meaning in 1994, and then beginning in 1995 we sent them out in about four different transmittals to the NRC regional offices and the agreement states for comment. They
went out in groups of two and then the last one to go out was the revision of the existing policy and guidance director for remote afterloaders. And that's the last one that has just And so there hasn't been a big
hit the streets for comment.
comment period left on that one, but that document has been used for some time. So where we're at now is that the working groups have all received all the comments and have reviewed those, have revised their modules accordingly to incorporate those comments. And we wanted to get ACMUI's input at this point so
that where the groups will go from now is revising their modules based on your comments again, and then also developing a standard review plan, which will basically be the module itself, a checklist, and a model license. Now those standard
review plans will be updated and modified and developed this
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 fall, and then distributed to the regions for use. is to get those out to the NRC regional offices by December 31, 1995. Those will be for use by the regions. Our goal
Now we realize we're putting something out for use that in fact will subsequently go out for public comment. But that's okay. The regions have had an opportunity to
comment on them; they need to begin to using them, and then to tell us if there are voids or inaccuracies, or what have you. So the goal is to get them to the regions by the end of the calendar year, and then since we began this project, BPR, the business process reengineering project has really taken off and there's been a change in how we'll issue our modules. We'll issue our modules for public comment as
part of the overall, very broad materials licensing manual that's being developed by BPR. So these Red Guide 10.8
modules will no longer stand alone, but will be incorporated in the materials licensing manual. public comment. I would imagine now the timetable is FebruaryMarch time frame of 1996. So they'll be out to the regions And I think that's about it as And they'll go out for
just a little bit before that. far as where the project is now. MR. SIEGEL:
What's the plan in terms of bringing
the subcommittee suggestions in the revised documents back to the ACMUI as a whole?
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 generally. MS. SCHLUETER: what we did? obviously. MR. CAMPER: That's right. At this point, Mary, Okay, to talk about generally MS. SCHLUETER: Well, we'll have to figure out
how we would accomplish that if that's desired, because right now the time line for revising the modules, developing the checklist and module, is mid-November of this year, and you're meeting in October, so I'm not sure -MS. TAYLOR: It is on the agenda to talk about
Because that's only three weeks from now
there has not been a plan to take the revised guidance documents back before the entire committee. The plan at this
point has been have the subcommittee provide comments that would be a report of the subcommittee activities and findings to the full committee. meeting. That's on the agenda for the October
But there is a timing mismatch to have such a full
review, and furthermore, there's going to be a special meeting of the ACMUI as you know in February, but that's going to be the focus point in the NAS report, which in itself is going to be comprehensive enough for a full meeting. opportunity would be May. So the earliest
I don't know if that review is
desired by the committee or if it's necessary, but we can certainly contemplate that. MR. SIEGEL: Right. I wasn't really meaning to
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 press it. I think when we left it at the last meeting the
notion was that the most efficient way to do this was to have small groups of people sitting around trying to talk through some of these issues, and I'm perfectly happy with the notion that either, whatever our minutes are or brief reports of what significant changes might have occurred as a result of these three days worth of subcommittee meetings, got back by way of an information report to the committee as a whole. I think
the committee as a whole will not wish to take the time to go through any of these little details again. MR. CAMPER: When it's published, Janet, what's
the planned period for public comment? MS. SCHLUETER: licensing manual. Well, that will be up to the BPR
I mean I would imagine it would be no less
than probably 90 days, and probably longer. MR. CAMPER: February is the plan? MS. SCHLUETER: MR. CAMPER: June, July and August. At the earliest. So that would be -- You're saying
So February, March -- put you into Now the May meeting of the ACMUI I
assume will be talking about the licensing manual obviously as a significant agenda item. What you might be able to do, Barry, in your subcommittee -- Let's assume for sake of discussion that this goes along fairly smoothly. The subcommittee doesn't identify
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 any remaining outlying issues with which you have a problem. In that case it might not be necessary for the guides to go through the full committee. But by the same token, if it
turns out that there's some significant issue you could, a) address that in your report to the committee, and then we could add it as an agenda item for discussing before the full committee in the May meeting. And it might mean that we can
do that under the umbrella of talking about the licensing manual at large. MR. SIEGEL: MR. CAMPER: MR. SIEGEL: MR. CAMPER: That's fine. Okay. Yes, I think that's reasonable. Does that seem like that will work? Yes. Well with that
MS. SCHLUETER: MR. CAMPER: introduction.
All right.
Are there members of the audience who would There's a couple
like to introduce themselves for the record? folks. MS. BARRON: MR. CAMPER:
I'm Margo Barron from NUS. Did you get that?
Would you say that a little louder? MS. BARRON: MR. STEIN: Margo Barron from NUS. Gary Stein from the American Society
of Health System Pharmacists. MR. CAMPER: All right. There are members of 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 Medical and Academic Section staff. We have Sally Merchant; And Trish is also
Janet Schlueter of course, Trish Holahan.
working with Janet now on these modules and will be here over the course the next couple days; the assistance of the subcommittee if need be. Suzanne Woods, a member of the Medical and Academic Section staff. And of course Torre Taylor, a member
of our staff, who also functions as the administrative coordinator for the ACMUI activities. With that then, Barry, I will turn it over to you as the chair, and let's proceed. MR. SIEGEL: Good. I must admit I don't have a
plan, but we're here this morning to deal with mobile medical service module, and to try to get whatever issues there are out on the table. Let me ask -- if unless Dr. Wagner objects -- you or someone to begin by telling us what you have encountered as the most significant problems in the last few years in licensing mobile services. What have been the most
complicated issue for you all to grapple with? MR. CAMPER: That's an excellent question, and I
was looking through this last night and trying to look at some of the words we had put down and being struck by some problems -- I think the biggest problem area is that when it comes to mobile medical licensing there are two problems.
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 One, is that there is a regulatory problem. If I look at the
language today in Part 35 there are two primary parts that deal with it, 35.29 and 35.80. I think that the regulatory
criteria, while appropriate and worthwhile at the time when Part 35 was last revised, it may not necessarily be reflective of trends that are going on in industry today. We see And
somewhat of a increase toward mobile medical imaging.
that's really not surprising given some of the dynamics going on in health care today. Well if you look at language in 35.29 and 35.80 I think that one can make a reasonable argument that it's fairly restrictive, particularly with regards to the capacity for one to receive radio pharmaceuticals at a scan in van scenario for example. Some of the arrangements for interfacing with
hospital clients are cumbersome and may not necessarily be consistent with business practice in today's marketplace. But
unfortunately that will take a regulatory fix, an adjustment in the language. And we can deal with that problem when we
revise Part 35 over the next few years, and we can certainly employ the committee to help us do that. That's one problem.
And the fallout from that problem then is, is that what we do -- and in fact Torre and I worked on a case just last week on this. We're having to grant some exemptions
to some of the criteria in 35.80 and 35.29, and certainly the regulations obviously allow for the capacity to grant
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 exemptions. exemptions. You prefer not to regulate by the granting of You probably ought to modify your regulations and
over time you learn things and you ultimately do that. So that's a major problem, existing regulations. I don't know how to fix that other than adjustments to the language which we'll do in due course. But with regards to
the guidance though, what we might be able to do in guidance is to address some of these things we've already seen. For example looking through the guidance the last day or two, a couple things I'm struck by that aren't included that we might consider including, is some discussions of some of these changes that are going on in the industry, that potential applicants should consider their need for radio pharmaceuticals' procurement, what kind of arrangements do they want to have at site for being able to receive the materials and therefore alert them to the fact that certain parts of the regulations they may need to seek an exemption to. And in particular I think at 35(a), possibly (b), And then the other issue that we need to talk about Reciprocity is a very large scale problem in
35.29(d).
is reciprocity.
the sense that today we have a strong program in reciprocity where agreement state licensees want to come into NRC jurisdiction. There's a mechanism and a method for filing for
reciprocity, and they can get reciprocity for up to 180 days in a year.
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 Well, if one looks today at some of the regulations and guidelines that are subject to reciprocity, it becomes at least clear to me that they weren't developed with mobile medical imaging in mind, and the truth of the matter is that you can easily imagine the scenario where someone could be based in an NRC agreement state -- let's say Virginia for example -- and want to go right across the border to provide services in a town in North Carolina. And we say nothing
literally in the guidance at this point about reciprocity and some of the things that they need to be aware of. And my observation is, is that as mobile medical services continue to increase that will become more and more of an issue. We at this point have a strong potential to
receive an application for mobile, high dose rate mode afterloading service. interested in this. We have met with the company that's They were going to submit an application Currently our regulations That would require
by summer; they didn't do that.
don't allow therapy in a mobile scenario. a significant exemption.
It would require a significant
adjustment in policy in that regard. But again, we're faced with emerging technology and emerging changes in the way health care is provided. So,
I think then those are really the two big issues as I see them of large scale. MR. SIEGEL: Just a simple opening question which
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 time. MS. TAYLOR: I think we just changed it to give is, the module is called mobile medical service; that the corresponding regulatory parts are called mobile nuclear medicine service in 35.29 and 35.80? MR. CAMPER: MR. SIEGEL: That's right. And I wasn't sure whether the module
was named more broadly with the notion that it was intended to capture some types of radiation oncology practice? MS. TAYLOR: under 30 millicuries. MR. SIEGEL: MR. CAMPER: But that's still nuclear medicine. At least in theory, most of the Mainly to capture the radio therapy
it a more general name because it wasn't going to be strictly just nuclear medicine. MR. SIEGEL: But this module as it stands right
now, isn't that designed to address mobile HDR or mobile LDR if such were to exist? MR. CAMPER: MS. TAYLOR: another module, right? MR. CAMPER: Now let me just see if I can Some general issues It is not. That's intended to be addressed in
understand, and Lou interrupt me anytime.
related to how you think a license is currently written under a few scenarios.
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 Let's start with the common current scenario whereby a large hospital corporation, which is getting to be an increasingly common situation that perhaps owns 15 or 20 hospitals over a one state, two state, three state area, decides that for its ten world facilities it needs to have a mobile service because none of them is large enough to sustain a freestanding nuclear medicine department. Each of those component hospitals is itself a medical institution. The parent corporation may or may not be
considered a medical institution given this definition, which we'll talk about in a bit. Who would the NRC most like to have the license for the mobile service? A parent corporation, or does the NRC
want there to be ten licenses for each of the component medical institutions that receive the mobile service? MR. CAMPER: preference as such. Well, I'm not sure that we have a
What we're concerned about of course,
Barry, is it to be a clear delineation of control and authority; be a clear delineation of who is managing the radiation safety program, and who in the management structure is responsible. Now, in your scenario, if you have ten hospitals and let's say they all have a license; they all have limited specific licenses for sake of discussion. MR. SIEGEL: See that's the part I'm not sure
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 about, is whether they -- As I read this it seemed like they have to have a license. the parent corporation. MR. CAMPER: In your example as you were There couldn't just be one license to
explaining it I was envisioning a situation where you had these ten institutions. Each were medical institutions as
defined and they each had a license. Now, they could still -- That corporation could still under that scenario come in and get a mobile medical license under Corporation A, let's say. They could then
decide to go to some of those existing limited specific licensees that are their hospitals and decide to provide services to them. And there are some administrative considerations that are talked about in 35. You have to have, of course,
letters of permission if you're doing some of the same things that the institution is licensed for then you have to recognize that those things come under the control and responsibility of a licensed institution. currently set up. That's the way it's
I think by the way that's an awkward
arrangement, but be that as it may, it's the way that it is today and until such time that we change that. it's 1995; it's not today's reality. But, they certainly could do that then. They'd I don't think
have to operate under existing administrative restrictions.
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 that's -MR. CAMPER: that same context. I wouldn't even think of the Navy in But we would issue a licensee to one. But again, if you had
ten licenses in this corporate chain and you also had one license for this corporate chain that was mobile, we would be looking in each case for a clear delineation of who's in charge, who's administratively responsible, who is a radiation safety officer, who's conducting the program and so forth. But we don't look at it as a preference for one or the other. MR. SIEGEL: But do you currently require that if
one of the clients is a medical institution that there has to be a license at the medical institution? MR. CAMPER: MR. SIEGEL: No, we do not. So there could be a single corporate
license to cover the activities of the whole operation? MR. CAMPER: MR. SIEGEL: MR. CAMPER: MR. SIEGEL: Yes, there can be. And the Navy would be -Well, no. I mean I know that's not mobile, but
The Navy and the Air Force have a unique And
situation, that they have master materials licenses.
what's terribly unique about them of course is that they do their own licensing. inspections. They issue permits. They do their own
They undergo audits by us and we participate in But
their radiation safety program management and so forth.
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 that's a distinctly different program. If we had a Corporation A that had a mobile license and it had ten -- Let's take a scenario. for example they had ten hospitals. Let's say
They were doing
diagnostic only and limited therapeutic nuclear medicine, let's say up to 30 millicuries. They decided they wanted to
cancel all ten licenses and have one mobile corporate license, they could certainly do that and then go to each facility and provide the diagnostic nuclear medicine capability. And
frankly I suspect in the future you'll see some of that type of activity. MR. SIEGEL: And then would the mobile service Would the mobile service
have a radiation safety committee?
itself become functionally a medical institution? MR. CAMPER: That's an interesting question. I
want to talk about that in some of the language we have in this guidance today. But not as currently structured, no; not
in existing regulatory parts, NRC would not be required. MR. SIEGEL: MR. CAMPER: Okay. I mean we have mobile licensees
today that are corporate entities, that go provide services, and they do not have a radiation safety program. MR. SIEGEL: Are there mobile services -- Is
there any substantial number of mobile services that go to hospitals that are already licensed to have nuclear medicine
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 interface. exactly. MR. LYNCH: MR. CAMPER: MR. SIEGEL: There are examples. But there are certainly mobile -And so what happens at the interface I mean obviously that's one of services? MR. CAMPER: I don't know what the numbers are
between those two licenses? the problems. MR. CAMPER:
I think there are two aspects to the
I think on one hand, if you look at our
regulations it says that, if you're going to go into an institution for them to be a client there has to be a letter saying, we want your services; you can come to our institution and provide services. Then it also says though that, if
you're going to provide the same services that my institution, the hospital, provides, that when providing those services at my institution my hospital is responsible for what goes on. Now I suspect as a reality that gets very fuzzy and I don't know, Jim, what we've seen in terms of inspection findings to what degree that is a problem, but I can certainly see where that could be a real area for problems. Because
again, it's okay to say that as the institution that I'm responsible for this. I guess the question becomes, to what
degree is the institution radiation safety officer and the institution radiation safety program truly overseeing and
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 monitoring what's going on by that mobile service entity while they're in their institution. And I guess like, the truth to
be known, Barry, it's probably like every other radiation safety program; it's highly variable. MR. WAGNER: That's the difficult thing as I was
going through the module that I found very difficult to understand. If the mobile service provides services to a
place that doesn't have a license then the mobile service is responsible for everything. MR. CAMPER: MR. WAGNER: Right. But if the mobile service goes to a
place that does have a license then it is the place they're servicing that is responsible for everything. MR. CAMPER: For those licensed activities of the If we
institution that the mobile service is also providing.
take the most simplistic example, 35.200, which obviously is the broad band of imaging, if they're in there doing bone scans, liver scans, mugas, etc., yes, if the institution has 35.200 authorization and the mobile service is doing it, the institution is responsible as the regulations are currently structured. MR. SIEGEL: So the mobile service under those
circumstances is just a contractor? MR. CAMPER: MR. SIEGEL: True. It's just providing contract
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 services to a licensed institution in a way then gets treated the same way that a contract, god forbid, radiation safety officer or health physicist is treated by you all? The institution has the responsibility. MR. CAMPER: MR. SIEGEL: That's right. But even though the mobile service It has to have its own license.
itself has its own license.
Now, if a mobile service just moves an imaging instrument around does it need a license? MR. CAMPER: MR. SIEGEL: No. If the administration and by product
material occurs in the institution for use on the mobile service's imaging instruments, but the mobile service itself never possesses by product material -MR. CAMPER: That's correct. It's about That's what causes
possession and use of by product material. the license to be required.
In the scenario you're
describing, that would be by product material, licensed, and under the control of the medical institution. Now, with regards to the mobile for medical and some of these administrative requirements that are currently in 35.29, I think what you have here -- and this gets back to the first problem that I was addressing. In 1987 when the
regulations currently became effective and they were promulgated and developed back in '85-86 time frame, I don't
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 think that mobile medical imaging was the same thing then that it is today. And so much responsibility was placed upon the
medical institution in the classical sense of how have we approached licensing. There's two major components; the It's been that way for
institution and the authorized user. years.
But I think what you have today, is you have business arrangements today for an authorized user for example. It's an active player in a mobile medical service.
Then you face a question -- again, this is something we'll have to deal with in the future as we revisit the regulations. Under that scenario or some similar scenario, shouldn't the mobile medical license be clearly identified as being responsible for all aspects of the radiation safety program, even if an institution has a license. question we have to discuss. MR. WAGNER: Well I must admit I was extremely It I don't know, there's a
confused as I was going through and reading these things.
would be very very confusing to understand who is responsible for certain activities given the fact that both would have a license. The mobile medical service comes in with their
services and yet once they get on their property the institution that they're servicing takes over the responsibility for the regulatory practice, and that to me is extremely cumbersome. I can't imagine how that could be
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 worked out in a reasonable event if something occurred. be responsible for what? Who'd I
It would we very very difficult.
mean if something goes on inside the van that is a problem then technically the institution they're serving is the one responsible for that, and how can they possibly be responsible for that when they are not the company providing those services? I mean it seems to me that we have created a very
convoluted problem here that may be intractable. MR. CAMPER: I would agree with that. Again, the
logic that was applied -- and I don't think you'll find an awful lot about this in statement of consideration. If you go
back and read them you'll find some limited discussion but probably not to the detail that we would like to have today. But the idea is that, the institution has a license, the institution has a defined radiation safety program. They have a designated radiation safety officer. And that being is in
They have a radiation safety committee.
a position then to oversee what's going on in that scan van just like it would any other component of its by product material use program. And therefore you're going to apply
certain management and administrative controls and reviews in that just like you would for the nuclear medicine department, or even some satellite cardiac imaging room or something of that nature. That was the mind-set that brought those
requirements in 35.29 to bear.
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 MR. WAGNER: So I see what you're saying. What
you're saying is basically times have changed and those regulations were developed on certain scenarios. Those
scenarios no longer exist, but unfortunately we're set with regulations that apply to scenarios that don't exist and now we're trying to figure out ways to apply inappropriate regulations to the current situation. MR. SIEGEL: MR. WAGNER: MR. LYNCH: Well appropriate is a strong word. Something like that. There is one other issue and that's If there's some technetium 99-
the ownership of the material.
M spilled on the floor of a nuclear medicine lab, I can't tell if that's from my hospital program or if it's from your mobile service. So theoretically both licensees could be using
material, the same material in the same area, and you can't physically tell them apart. MR. SIEGEL: How big a problem is this? I mean,
what kinds of problems have you encountered, not at the licensing end, but at the compliance end? When you inspect
the operations of mobile services and the clients they serve have you found problems? MR. CAMPER: MR. LYNCH: Do you want to follow that? I can't think of any significant
problems that were identified. MR. CAMPER: Similarly here. I can't recall any
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 the future? kind of compelling case. Is anyone else on the medical staff? interesting question for the following reason. That's an As I see
mobile applications today -- we've had two or three recently. One out in the west that wanted to transport generators on the van, which requires an exemption to do so. The scenario we
had recently when they were talking about wanting to receive materials at the van, and so forth. What I'm saying, Barry, is that, I think that historically mobile medical services have performed in a satisfactory manner. We have not seen unusually high
violations in that type of licensing entity as compared to normal, the medical institutions. But having said that, at least my sense is -- and seeing some of the things that have been going on today -- mobile medical imaging, mobile medical services involving radiation are changing, are evolving. Now, is that a precursor to increased problems in I don't know. I couldn't predict that. But I
certainly see scenarios today where people want to do things differently than the regulations currently allow them to do. And you would think then if they assume more responsibility for receiving materials. They want to transport materials in You certainly Will that
the van; the generators and so forth and so on. can see a heightened possibility for problems.
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 materialize? I don't know, but it's changing. But this module that we were going
MR. WAGNER:
to review only applies to diagnostic, it doesn't apply to giving you any advice regarding how you would grant exemptions for other issues. MR. CAMPER: It's diagnostic and limited But a couple of things I
therapeutic up to 30 millicuries.
think we ought to ponder is, to what degree should we put any language into this guidance where we bring to the attention of potential applicants some of the changes that we're seeing. And again, the two that come to mind are the 35.29(d) and the 35.80(a) and (b) which we can talk a bit more in detail. And
what should we be, if anything, informing potential applicants about the possibility to seek exemptions if that's not consistent with the business that they want to provide. And
then the second thing is this issue of reciprocity, and to what degree should we alert them to the need for pursuing reciprocity. If they're going to an NRC jurisdiction, to an
agreement state, have a reciprocity scenario they need to address that. And it may be as simple as awarding them to the
reciprocity process and informing them that if they want to pursue imaging in an agreement state they're going to need to contact that agreement state and do whatever is necessary for reciprocity in that specific agreement state. And by the way -- and this is further compounded
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 this thing. by the fact that, remember that agreement states handle reciprocity differently, and in varied fashions than we do. They don't all have the same reciprocity scenarios. MR. SIEGEL: How do we want to do this? Do we
want to start just walking through this thing?
These comments
that came from the regions and others we obviously just got, and so have not had much chance to digest them. MS. TAYLOR: And to be honest, most of them are
pretty editorial; clarify this or change this word to that. There are a few things that the regions had asked that we put in that we felt would be too prescriptive in the sense of limiting programs. MR. SIEGEL: Let's just start walking through
Let me start off by asking a question. It says on page 2, Location of Use; that
locations of use may include, medical institutions, medical non-institutions -- I'll come back to that in a moment -- and commercial -- I'll have a term for you that will solve the practice -- and commercial facilities. And then on the very next page, it says, if the application is for medical use located in a medical institution, only the institution's management may apply. I didn't get it. Is that true? And
I just asked you a moment ago
whether there could be one license provided by the corporation and the medical institution didn't have to have a license.
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 And this suggests that the medical institution has to have a license. MS. TAYLOR: This is where the mobile service is
located within a medical institution. MR. SIEGEL: MR. CAMPER: differently. I'm very confused about that. Well, I look at this a little
I was looking at this last evening, and I can
give you my notes in the margins, say, it doesn't work; it's a problem. What we've attempted to do here, is we've lifted the definitions on Part 35 currently for medical institutions, medical non-institution and commercial facility. moved them verbatim almost. And we have
Now, if poses some problems
because again, as you just were pointing out, a pure commercial entity, they want to do services in the medical institution, some of the things we have written here as definitions I think are problematic in that regard. MS. SCHLUETER: Well I think the reason that that
statement's in there is because of 35.12, in the sense that, if the applicant to perform mobile services is a medical institution then the medical institution's management must apply. But that does not apply to the client who may be
medical institutions that may be having services at their facility by the mobile service. MR. LYNCH: Right. So what you're saying is that
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 clearly. if the licensee, the proposed provider of mobile services, is a corporate entity that is a medical institution then management has to apply as opposed to a person? MS. SCHLUETER: MR. CAMPER: MR. SIEGEL: Correct.
That's correct. But then we need to say that more
Because a mobile service that is a free standing
corporation could provide service inside its van parked next to an medical institution, and at that point the licensed activity is not considered cited at a medical institution, or is it? See, that's where you're running into a language
problem here. MR. CAMPER: for example -MR. SIEGEL: MR. CAMPER: I'm looking at 35.12. Well, if you go back up to page 3, Well, if you look at the first one
if you look at (a), if you're reading this -- You're out there, you're a potential applicant. If the application is
for medical use located in a medical institution -- Well, if I've got a mobile service I'm going to be providing it for medical use. institution. I'm going to be providing in a medical Only the institution's management may apply.
But what we're really saying here is, if a hospital, which is a medical institution, wants to provide mobile, medical imaging services then the management of that medical
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 Part 35. MS. SCHLUETER: Those definitions come from an minutes. Where are those definitions? They're not in other -MS. SCHLUETER: MR. SIEGEL: I have to go back to my desk -institution must apply. MS. TAYLOR: MR. SIEGEL: But we're not as clear about that. That's what it needs to say. It clearly does need to say that,
because that, I thought, was very confusing. The definitions of a medical institution in a
No, but I can fix it for you in two
office of the general counsel interpretation in June of '94, which helped the staff try to figure out when the management needed to apply, when they did not, and if you needed a radiation safety committee and other management program aspects. What precipitated that was the fact that there are
more and more private physicians, more as you know, which are combining, incorporating themselves and so forth and so on, and are licensed for activities in the same types, quantities and program aspects that medical institutions are authorized for now. So in other words, you have these groups which are combining and growing and are in fact offering the same type of services and are licensed for the same kind of things
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 as the hospital next-door, but because they're private physicians they've been coming under a different program code, they've been licensed in a different manner, they haven't had to have a radiation safety committee, and so forth and so on. So there are groups of private physicians that are beginning to walk and talk like a medical institution. So there was
some attempt at trying to set some criteria for deciding, how big could they be, how much could they grow, what could they offer, what could they be authorized to do and not hit that threshold for medical institution, radiation safety committee and other kind of program management requirements. Now, we made an attempt at trying to define that line, that threshold. There are some problems with the There are minor ones,
definition when we began to apply it.
but it gets back to how does the physician group function versus how the medical institution. The term is cumbersome
and we tried for a long time to figure out something else. MR. SIEGEL: Would you like -Sure.
MS. SCHLUETER: MR. SIEGEL:
Non-institutional medical practice.
Medical non-institution is not a language that I'm familiar with. MS. SCHLUETER: Well I don't think it was a We were just trying to
language anybody was familiar with. come up with --
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 MR. SIEGEL: Non-institutional medical practice
will capture your spirit -MS. SCHLUETER: MR. SIEGEL: Similar but more descriptive.
-- and I think is English.
Now let me tell you about your definition of a medical institution here. are practiced, and more than one physician is associated with the medical practice regardless of the number of authorized users. this definition -- I think I said this at the last meeting -- two physicians practicing together in a partnership could constitute a medical institution. You could have one By Three or more medical disciplines
guy who's a surgeon and an obstetrician, and does both, and another guy who's an endocrinologist and a nuclear medicine doctor, and is an authorized user and that makes those two guys a medical institution. Who would be on the radiation safety committee? MS. SCHLUETER: medical disciplines. MR. SIEGEL: are only two guys. a secretary. I just said there were. But there If there are three or more
They have no staff.
They don't even have
Two guys in an office put up a shield somewhere. No offense to I
This definition is cumbersome; it don't work.
the lawyers, but I don't think they got this one right.
mean that's as clearly a group medical practice as I can think
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 of, and it could be set up as a partnership so it would not be licensed in any state as a medical institution the way hospitals are licensed, the way free standing clinics are licensed. It'd just be a couple of guys who hung out a
shingle and went into business. MR. CAMPER: differently. Well let me take that a little
What makes an institution and institution? I haven't got a clue. I don't know.
MR. SIEGEL:
I mean that's part of the problem.
And if you think about
it -- and we've dealt with some of this before -- you've got this corporate entity called the hospital that has a bunch of doctors working in it who are sole proprietors, who come in and use the hospital's facilities, and agree to follow the rules while they're working in the hospital, but really have essentially no other fiduciary relationship to the hospital. And that includes authorized users in many hospitals who are, not employees of the hospitals. The only authority the
hospitals has over those physicians is the ability to take away their staff privileges and not allow them to practice in the hospital. MS. SCHLUETER: MR. SIEGEL: I guess --
But can't otherwise directly That's actually a
supervise the activity of those physicians. fairly traditional medical institution. MR. CAMPER:
Is there something -- Over the last
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 not. 25, 30 years, we've grown to think of the hospital as a medical institution. Is there something in the charter Is there
they're given or when they're licensed by the state? some criteria that gets at what an institution is? MR. SIEGEL:
My guess is yes, but I don't know. The one case that we had that
MS. SCHLUETER:
sort of put the definition to the test, and we soon realized that we had some problems with it was, a scenario in which a private physician office building located next to a hospital had several physicians in it, one of which was an endocrinologist, one of which was a nuclear medicine specialist, and there were other physicians, non-by product material users in the group. Now previously they had separate distinct licenses, but the physician group had incorporated themselves, so there was one organization at the top that these physicians all reported to, if you will. And so then we had this
scenario where we had this corporation, this entity, this building with several authorized users in it, that in theory had a corporate relationship, but were holding separate licenses. And so the question was, shall we re-issue the
license to the corporation instead of the single users? And so in the long run I'll tell you that we did We did not actually apply our own definition, because it
seemed illogical to force the corporation to have the license
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 35.2. instead of the endocrinologist for example, mainly because the inspection history was very good, was very limited, and why impose the burden on both the NRC and the licensee to go through a licensing process again. So we've only had a couple of cases really where we've had to try to apply this working definition, and there is some difficulty in applying it, and we do have to make case by case reviews of these situations. And it may be that over
time we can revise it to reflect how we evaluate these scenarios. It was a shot at distinguishing a threshold and
it's just not quite there yet. MR. SIEGEL: I missed this definition in 35. Well it's not there in the sense
MS. SCHLUETER:
that you'll find 35.2 has a very limited definition of medical institution. CHAIRMAN SIEGEL: It makes more sense. No. But I like the way it's in
An organization for which several
medical disciplines are practiced is actually easier for me to understand and apply common sense logic to than this definition, which I find to be very, very awkward. MR. CAMPER: I did, too, Barry, but, you know, I I
mean, I can quickly identify a scenario of organization. mean, what if you have a corporate entity, five or six physicians get together and form a corporate entity and they're practicing several disciplines? I mean, arguably,
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 -MR. CAMPER: Well, you know, and what's really them. that's an organization. organization. CHAIRMAN SIEGEL: Well, according to this I mean, a corporation is an
definition, you would license that as an institution. MR. CAMPER: Yes. But bear in mind another
reason why this has become a problem in recent years is fees. MS. SCHLUETER: MR. CAMPER: Fees.
That same private practice group
that I just described would argue that it's a private practice physician scenario, not a medical institution. therefore, subject to a lesser fee. MS. SCHLUETER: Fees do come into play. And It's,
that's why we also worked with the Office of the Controller to develop that definition. MR. CAMPER: In fact, I think it's fair to say
that fees were a significant -CHAIRMAN SIEGEL: MR. CAMPER: Were the driving force.
-- driving force, certainly one of
Janet's described a couple of others, but that was also
one of them. CHAIRMAN SIEGEL: Well, this is a killer. I just
problematic about that is, you know, the regulations and the definitions in regulations were designed and built about
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 radiation safety, control of materials. anything at all to do with fees. CHAIRMAN SIEGEL: MR. CAMPER: Right. Well, that hasn't got
And, I mean, the regulations are
really blind to fees, as they should be, but let's face it. The reality of the matter is you move along and fees continue to increase. so forth. And you have this private practice scenario and
People begin to try to find ways to lessen the
burden of fees. CHAIRMAN SIEGEL: for a moment. MR. CAMPER: Right. What is it you think needs to Well, then let's forget fees
CHAIRMAN SIEGEL:
be achieved from a radiation safety point of view that compels you to distinguish between -MR. CAMPER: Right. -- a medical institution and a
CHAIRMAN SIEGEL:
non-institutional medical practice? MEMBER WAGNER: MR. CAMPER: That's the point.
Well, I think sort of a quick
layman's response is that the radiation safety committee concept grew out of a need to have an organization within this institution that was overseeing the fact that materials were being used for many different purposes and in many different settings in the classical medical institution, the hospital,
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 if you will. I mean, you know yourself you've got them going on on several different floors. scenario. You generally have a cardiac You
You have a primary group of medicine scenario.
might have an endocrinology clinic.
I mean, the idea is that
the committee assumes responsibility for the institutional oversight. By contrast, a private practice scenario, they're typically smaller. And the use scenario is more confined.
You ultimately have one or two docs, as you pointed out before. You can't make a committee. You don't have all the
players necessarily. So I don't -- I think that's the primary difference, this idea of multiple use sites, multiple program uses, and then an entity that oversees that for the institution. MEMBER WAGNER: But that makes sense. The
difficulty I think is that these definitions don't address that. These definitions seem to be more arbitrary than that.
And it's not clear how these definitions address that radiation safety issue. If you were to use that scenario, then medical institution and medical non-institution would be defined according to the types of procedures and quantity of procedures that they do.
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 with. CHAIRMAN SIEGEL: MS. SCHLUETER: Yes, yes. Yes. I mean, we recognize that,
having tried to apply them in several cases, it's not working and that we probably want to reconsider writing that section, basically in the tone that you two gentlemen have just described, and eliminating the definitions that are there now because I think it really will take a case by case review. And there's not such a fine line of a threshold. MR. CAMPER: You know, your point if you look
through the definitions, you're not struck with radiation safety. MEMBER WAGNER: MR. CAMPER: Right. That's exactly the point.
It's a driving consideration. That's what I had so much trouble And now we're
MEMBER WAGNER:
I go, "Why are they doing this?"
enlightened.
We know why you're doing this. Right. And I think we want to focus you
MS. SCHLUETER: MEMBER WAGNER:
back onto doing it for the reasons you should be doing it. CHAIRMAN SIEGEL: And, really, from a radiation
safety point of view, the key element is who is ultimately responsible: a single authorized user or a small group of
authorized users working together versus management with the requirement that management have an intervening radiation safety committee. Isn't that really a fundamental --
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 MS. SCHLUETER: Well, and I think operationally
we were moving in that direction, but this definition doesn't reflect that. CHAIRMAN SIEGEL: Now, the problem with simply
suggesting that you go backwards to a simplistic approach is that, I mean, one way to do it is to say more than one category of use in a practice constitutes a medical institution. But then the problem is, well, I mean, you have -- but many people have asked this question: Do you really
need a radiation safety committee in a hospital that only has a nuclear medicine department and only does imaging and has one authorized user who does the work? What does that
organization need a radiation safety committee for? MR. CAMPER: Well, it's a fair question. The
theory is that you have this committee and it has to consist of three, at least three, entities: nursing. The reason for
that is because materials are being administered out on the floor and so forth. CHAIRMAN SIEGEL: MR. CAMPER: Right.
And, therefore, the potential for
contamination, the potential for exposure, -CHAIRMAN SIEGEL: MR. CAMPER: Right.
-- having nurses who are in and
about and around this, having a representative and being
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 involved, institutional management obviously for management awareness and control purposes, obligations and responsibilities of the institution procure and has the license, the authorized user for the active hands-on understanding of radiation safety, et cetera, cetera. I mean,
that is the logic applied even in a strictly nuclear medicine scenario. That's where we are today and why, roughly. Now, as you expand the program, you're supposed to bring into bear -CHAIRMAN SIEGEL: MR. CAMPER: Other categories.
-- these other categories of users, oversight, awareness and
again for the same purpose: oversight. CHAIRMAN SIEGEL:
Okay.
I'm stuck on this one.
So where do you think you're going to go with this? MS. SCHLUETER: You know, I think we should
remove the definitions that are there now because it places us in a box that we don't want to be in. MS. TAYLOR: From our discussion, it sounds like
we could just take it all out, just rewrite it, ask them to describe in detail their management, corporation structure, describe the oversight, who has responsibility for what, and -MS. SCHLUETER: quantities, -Well, the type users, yes, the
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 this. MS. SCHLUETER: safety requirements apply. MR. CAMPER: point there. Yes. I think Janet's got a good -- you know, what radiation MS. TAYLOR: The type users, types, --- all that kind of thing.
MS. SCHLUETER: MS. TAYLOR:
-- disciplines being done and do it
from a very general -- let them bring it in in a license -CHAIRMAN SIEGEL: MS. TAYLOR: Inpatient versus outpatient.
Right. Because, I mean, you don't need
CHAIRMAN SIEGEL:
nursing involved if you never do an inpatient; correct? MS. TAYLOR: Outpatient; right. If you only do outpatients?
CHAIRMAN SIEGEL: MS. TAYLOR:
Right. I think we just need to let the
MS. SCHLUETER:
applicant be aware that we are going to look at all of those aspects of the program to determine whether or not -CHAIRMAN SIEGEL: I sure think that's better than
If we were to take Page 3, Page 4, Page 5 and
turn that into text that said, you know, "Describe what this thing is that you're applying for. Is it a medical Is
institution that wants to provide mobile medical services? it a private practice scenario that wants to expand their capability to include mobile medical? Is it purely a
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 commercial entity? You know, describe what's going on," get
the key points that we're looking for because I -- you know, you're right. These definitions just -Could you include as part of
CHAIRMAN SIEGEL:
that text, just as you did, several of the most common examples, not to be exclusive, but to say, -MS. SCHLUETER: CHAIRMAN SIEGEL: Right. -- "Common organizational
structures of mobile medical services include" -MS. SCHLUETER: CHAIRMAN SIEGEL: Right. That would help. I
-- and list four or five?
guess it's unlikely that people who haven't got a clue how to do this are going to be applying for it, but I suppose it's -MS. SCHLUETER: MR. CAMPER: It's happened.
Business is business. That's right. Let's go into mobile nuclear
MS. SCHLUETER: CHAIRMAN SIEGEL:
medicine and see what we can -MR. CAMPER: mobile medicine. CHAIRMAN SIEGEL: MS. SCHLUETER: CHAIRMAN SIEGEL: It sounds good to me. Got a good deal on a van. Well, good because I think that Car sales are down. Let's go into
if you can make these arbitrary definitions disappear about the number of --
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 at all. them. MS. TAYLOR: We can do that. Yes. We're not wedded to those
MS. SCHLUETER:
And there's nothing final, formal, regulatory about There's a guidance tool, but -MR. CAMPER: Yes. In the future at some point,
you know, when we head down the pathway of revising Part 35 in the future, over the next three or four years, these kinds of things will be obviously, you know, significant, subject to discussion with the ACMUI. Getting some definitions will make
some sense that are modern and that will work. MEMBER WAGNER: John Glenn in this memo? MR. CAMPER: Okay. I don't see the date on here. And much of the I Should we go over the comments by
MEMBER WAGNER:
mean, he addresses many of these issues.
issues that he addresses in here are apparently based upon finances. I mean, he's got all kinds of things in here. MS. SCHLUETER: This is the June 1994
interpretation of the definitions for medical institution and non-institution. Well, this wasn't a commentary to the -This was a TAR. Yes. It was a response to a TAR,
CHAIRMAN SIEGEL: MS. SCHLUETER: which was created.
The definitions that we recognize now in
applying them aren't working. MEMBER WAGNER: So this is what created those
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 finances. definitions? MS. SCHLUETER: MEMBER WAGNER: That's right. And clearly it's based, at least
in my gleaning over this, it appears to be based, upon finances. MS. SCHLUETER: Well, it's not based upon
We had to consider the impact -CHAIRMAN SIEGEL: MS. SCHLUETER: No. It really shouldn't be.
-- of the decision to categorize And so we had to consider But it was us, the
one group one way versus another.
that from the Office of the Controller.
Program Office, working with general counsel with input from the controller. But that certainly was not the driving force
behind why we did it and how it came out. MEMBER WAGNER: No, but, I mean, it comes into He's talking about license
the consideration here, obviously.
annual gross receipts of a million dollars or less to qualify as a small entity and pay the reduced annual fee. MR. CAMPER: I mean --
I recall that, at least to some
degree, there were several things that converged at one time that prompted us to do this. But, amongst those things, I I think
believe the situation -- Janet, help me out here.
that in a couple of cases our inspectors had found themselves in situations where they had questioned their management as to whether or not this large, sprawling physician entity which
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 was growing and expanding was, in fact, a private practice scenario versus an institution. And some of those questions,
some of those concerns from inspectors were motivated not by finance, -MS. SCHLUETER: MR. CAMPER: No.
-- but by the question of whether or
not a radiation safety committee should be -MEMBER WAGNER: MS. SCHLUETER: MR. CAMPER: Yes. Okay.
Right, right.
And then in a couple of cases there
were some questions where some of these small entities were questioning or medical institutions were questioning, "What's going on over here? Why am I subject to this?" Right. "Hey, these guys look
MS. SCHLUETER:
like us, and they're paying a lower fee." MR. CAMPER: Yes. "These guys look like us." So
there were several things going on. CHAIRMAN SIEGEL: got it right, man. MR. CAMPER: Where is he? Well, in his note at the end, You know what? Stuart Treby
CHAIRMAN SIEGEL:
the very end of this thing, -MR. CAMPER: I don't have a document. Is it the whole thing, very end
MEMBER WAGNER: of the whole thing.
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 CHAIRMAN SIEGEL: whole thing, it says, -MR. CAMPER: Yes. Stuart Treby. There he is. Well, the very end of this
CHAIRMAN SIEGEL:
-- "The size and composition of
the radiation safety committee as specified in 35.22 suggests that a medical institution would be sufficiently large so as to have a management structure and nursing service and also might have varied authorized users for different types of byproduct material use." He goes on in the next paragraph, further down, and says, "Based on the definition of medical institution in Part 35 and the special requirements in Part 35 applicable to a medical institution, it is apparent that it must be an organization in which several medical disciplines are practiced of sufficient size so as to have at least three individuals on the radiation safety committee, including an authorized user of each type of use: nursing and management."
So it seems to me that in a way the key element is if there ain't a nursing service, it's not a medical institution. If there isn't an independent management
structure outside of the authorized users, it isn't a medical institution. And that also really gets to the heart of the
radiation safety issues, too. MR. CAMPER: Yes, it does. Yes.
MEMBER WAGNER:
I really like a lot of this,
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 although I still can come up with a little bit of difficulties on scenarios. there. And that is if you have the mobile service
The mobile service then injects the patient, does a
scan, sends the patient back into the hospital, where the patient is going to be taken care of in the hospital by the hospital staff. The mobile service itself doesn't supply any
nursing, but, of course, the patients when they go back go back into the hospital. So now the issue is you've got the mixture here. And do you need a radiation safety committee in that regard? You're going to have other people involved, but you're not going to have it involved with the mobile service. MR. CAMPER: Well, yes. I think that there are I think
two things that are going on here simultaneously.
that when we ultimately revise Part 35, we need to go back and look at the definitions in Part 35.2, be more explicit and clear about the role of the radiation safety committee. I agree. articulating. MEMBER WAGNER: MR. CAMPER: Yes. I think Stu has done a very good job of
In this type of background, frankly,
I think it should be in the statement of considerations at that time. Okay? Now, with regards to the immediate problem at hand, though, what I think we need to do here again is have
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 them describe, you know: for the mobile service? applying? Is a medical institution applying Is a private practice scenario
Is a corporate entity, commercial entity? And, for example, if it's a medical institution
that's expanding its armamentarium to include mobile imaging, then we should be looking and expecting the radiation safety committee to be providing some oversight for that service as well as part of that institutional service pattern. It would be just like, if you will, the fact that you have a representative there from therapy or endocrinology. In that committee, they would be exercising some oversight on behalf of the institution over that mobile medical imaging scenario. By contrast, though, if it was a private practice scenario, which doesn't have a radiation safety committee, that wouldn't happen. It would be the radiation safety
officer management that would be overseeing the mobile scenario. So I think if we avoid these definitions, ultimately fix these definitions but avoid them for purposes of this guidance document but focus upon getting a clear delineation on the applicant as to who's applying, and then bringing to bear some of these things we have talked about, that's probably a better approach. MEMBER WAGNER: I think that approach is much
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 well. therapy. MEMBER WAGNER: -- and limited therapy, all of better. The issue I think should be the fact that we have to
remember this is all diagnostic -MR. CAMPER: Well, it's diagnostic and limited
which can be done on an outpatient basis anyway. MR. CAMPER: That's right. So it really shouldn't play into
MEMBER WAGNER:
a big problem until you go to therapy. CHAIRMAN SIEGEL: I withdraw my comment about:
What do lawyers know about the definitions of medical institutions? MEMBER WAGNER: MS. TAYLOR: MR. CAMPER: Yes.
Stuart was exactly right. Made you a believer. He did a fine job.
MEMBER WAGNER: MR. CAMPER: fairness, too, to OGC.
Well, you know what I think, in all I think what may have happened here is
that, as often is the case, you get a complex legal answer. Then you try to extract from that key operational line items. It gives you a working model, which is what's reflected here. And I think Lou has kind of pegged it pretty If one looks at this, this has a lot to do with just
institutional size, fees, so forth, and not so much about radiation safety. And that's probably a mismatch.
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 definition? practice. MEMBER WAGNER: CHAIRMAN SIEGEL: That's much better. And the fact that we called it But it was, as Janet said, an attempt to have a working model at this point in time. You know, we've got this
house on shifting sand right now because of these fee changes and so forth. CHAIRMAN SIEGEL: All right. Well, fine. We've
dealt with the definition -- that's big progress -- and came up with a better term. MR. CAMPER: I hope you like it. That's the non-institutional medical
a medical practice is not a problem because, I mean, basically this has to be -- is that a problem? No. Wait a minute.
Commercial service that is in no way, shape, or form a medical practice be licensed to provide mobile medical services. mean, that's the other problem. MR. CAMPER: Well, can you have that by How can you I
I mean, how can you -- restate that.
be providing mobile medical services if you're not involved in some -CHAIRMAN SIEGEL: at the resident facilities. MR. CAMPER: commercial entity. That's right. Yes, you could be a By having only authorized users
And a good example of that is a scenario
you described early on, where I have camera on truck, travel
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 this -to -CHAIRMAN SIEGEL: I don't care what we do as long examples. MR. CAMPER: That's fine, yes. We're just going to institution. CHAIRMAN SIEGEL: But that's not even a licensing
issue as long as I'm not possessing byproduct materials. MR. CAMPER: licensed in that case. That's what I'm saying. Okay? You can have -Can a commercial entity possess They're not
CHAIRMAN SIEGEL: byproduct material -MR. CAMPER: the site only; right?
Sure, by using an authorized user at I can come in and get a license -Is that a non-institutional
CHAIRMAN SIEGEL:
medical practice that commercial -- actually -MEMBER WAGNER: CHAIRMAN SIEGEL: MEMBER WAGNER: CHAIRMAN SIEGEL: MEMBER WAGNER: Why don't you call it -Actually, it's a third -You have commercial. Never mind. Would there be any reason to
change "practice" to "service"? MR. LYNCH: At this point we're just giving
as we get rid of the word "non-institution." MR. CAMPER: We're going to rewrite this, take
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 Okay. MR. CAMPER: I had one more comment here, too. -MR. CAMPER: Well, what we'll do is when we MS. SCHLUETER: CHAIRMAN SIEGEL: You don't like that word? We don't know what it is, but
we know it's not an institution. MEMBER WAGNER: Right. Take this approach or we
rewrite this and tell them to describe what it is, you know, describe: "Is it a medical institution that's providing? Is
it a non-institutional medical practice that's expanding to include mobile medical? It is a commercial -- for example, is
it," dot dot dot dot dot dot. MEMBER WAGNER: Good. I like that better. Good.
On Page 6 under the definition of commercial facility, I was struck by something. If you look there, it's the paragraph
that says, "In some cases a mobile service" blah blah blah. CHAIRMAN SIEGEL: MR. CAMPER: Yes.
You get down to the point where it
says, "Submit documentation of the agreement between the client and the mobile service in the event of disharmony between these two entities. It is essential that the mobile
service have access to the facility in the event of contamination." Really? Why?
You're telling me that I couldn't handle
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 exactly. MR. CAMPER: Well, in either case what I think property. actually. MEMBER WAGNER: on their property. MS. TAYLOR: Right. They wanted to ban you from their And they didn't want you to come decontamination on a mobile van if I had appropriately trained individuals? I don't need to get into the hospital. What are
they going to give me, material to clean it up, swabs, decon. material? I mean, I could certainly do that. mobile service could certainly do that. MS. TAYLOR: I think this is more in the I mean, a
situation where they would be in the hospital and have a spill and they need to be able to get into the hospital in the event of disharmony if the work was being done inside the hospital versus the van. MEMBER WAGNER: I took it to mean that if your
van is on their property and there's a problem and then there's -MR. CAMPER: MS. TAYLOR: Right. Well, it could say that, too,
MEMBER WAGNER:
You've got to be able to get back to your -MS. TAYLOR: Yes, you can take it that way, too,
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 on. CHAIRMAN SIEGEL: Let me ask you a question. If entity. what's important is that we get some clear understanding that the mobile service has the capacity to deal with a spill, contamination. And you can certainly do that as a self-contained I don't necessarily need to get into the Nuclear
Medicine Department in the hospital 10 feet away to do that. In fact, I mean, I should be prepared, the mobile van should be prepared, to deal with a spill immediately. MEMBER WAGNER: To contain it, of course, and so
I give I-131, less than 30 millicuries, to a patient for therapy, 29.9 millicuries, the patient leaves my hospital, walks outside into the parking lot -- no, not the parking lot -- walks outside onto the public sidewalk, -MR. CAMPER: Throws up. -- and proceeds to throw up,
CHAIRMAN SIEGEL:
what is my responsibility, if any? MR. CAMPER: were released. CHAIRMAN SIEGEL: MR. CAMPER: Correct. If you have released them, then they
You may have a social
responsibility, but you don't have a regulatory responsibility because the criteria has been established. CHAIRMAN SIEGEL: So now let's say I am a mobile
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 case. CHAIRMAN SIEGEL: Well, I mean, you don't want a service and the patient walks out of the van and has been released from my service, walks into the hospital, which is attached to the van by a little bridge, and throws up in the hospital and the hospital also happens to have a license. Still nobody's responsible for cleaning up that spill; right, other than the social responsibility? MR. CAMPER: That's regulatorily correct. Because we would hope that both
CHAIRMAN SIEGEL:
of them would have enough sense to clean it up. MR. CAMPER: It's good for business in either
pool of vomit sitting on the floor in a hospital. MR. LYNCH: There is also the ALARA principle as And that would kick in at
well as reasonable and achievable. that point, too. CHAIRMAN SIEGEL: better for your -MR. CAMPER:
But you could argue that it's
Good health physics practice would
mandate that you bring ALARA into bear, but, again, if you're looking at it from the letter of the regulations. MEMBER WAGNER: I had the terrible problem of
where the patient went home in their house with their children there and threw up. And I was notified about it.
And I wanted to go in and help them clean it up
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 facility. me. MS. TAYLOR: with that sentence? MR. CAMPER: Well, I'm saying that it is Okay. So what do you want us to do problem. released? CHAIRMAN SIEGEL: This is getting complicated for in there, and they wouldn't allow me in their house. banned me from the property. They
They wouldn't allow the state or And so, yes, you've got
anybody to come in and talk to them. no control over this. MR. CAMPER: No.
You've got no control.
That's
one of the assumptions, the licensee, when you release them, you lose control. do anything. MEMBER WAGNER: Therein lies a lot of the When is the patient You cannot control the patient to make them
When is the patient released?
essential that the mobile service be prepared to deal with any decontamination scenario. MR. LYNCH: The problem here is access to the
The beginning of the paragraph says, "If a mobile
service leases a permanent or a semi-permanent space on client property." And it's just later saying that that service should have access to that facility. and kick them out. They can't lock the door
If they want to go in and clean something
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 service. MR. CAMPER: They leased the space from the They set up a scan van. I mean, they property. MS. TAYLOR: They were there. And they provided contract. CHAIRMAN SIEGEL: a mobile service," too. distinction either. MS. TAYLOR: Well, we had one case where they I didn't bring those TARs It also says "may or may not be up, they should be able to get in there. MR. CAMPER: It may not be a condition of the
And I didn't understand that
really were not a mobile center. with me.
They weren't considered -- the scenarios did not
make them a mobile service because they were -MR. LYNCH: MR. CAMPER: Scanning? Well, they put a scan van on a
hospital on their parking lot. MS. TAYLOR:
But it was permanent.
didn't take this van and move around. patients to that van. CHAIRMAN SIEGEL:
And our clients brought
So you viewed that as contract
services being provided to a medical institution and forced the institution to have the license? MS. TAYLOR: own license, too. No. The mobile service had their
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 not. it. CHAIRMAN SIEGEL: service that doesn't move. MS. TAYLOR: Right. It has the ability to move, but In other words, a mobile sense. MS. TAYLOR: Right. I see. MR. CAMPER: The mobile service had a license,
but the point is it's not -CHAIRMAN SIEGEL: MR. CAMPER: It wasn't mobile.
-- a mobile service in the classic
CHAIRMAN SIEGEL: MS. TAYLOR:
It stayed put, and people came to
MEMBER WAGNER: it doesn't move. CHAIRMAN SIEGEL: non-service. MEMBER WAGNER:
What we would call a mobile
Well, I mean, once we put in the
definition about whether it's a mobile service would mean whether or not it's -- if it stays in a certain area for more than two months, it will not be considered mobile or something. I mean, that's the other kind of -MR. CAMPER: You mean define the box -Yes.
MEMBER WAGNER: MR. CAMPER:
-- for when it's mobile, when it's
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 not. MEMBER WAGNER: When it's mobile and when it's
But as far as it's essential, I think what's appropriate
here is it's essential that the mobile service have access to the facility in the event of contamination. a statement. The question is: Do you mean contamination in That's too broad
the mobile facility, on the property leased by the mobile facility, or in the facility in the institution that's next to that mobile area? here? CHAIRMAN SIEGEL: MR. CAMPER: scan in van. Yes, yes. What types of access are you talking about
Well, the trend today is towards
I mean, the old, you know, pull up with the
mobile camera and roll it off the truck and go indoors, I mean, that's pretty much gone. I mean, it may be going on in
rural areas, out West in particular, but I think pretty much that technology has passed. this point. So the contamination is either going to occur primarily within the van, conceivably the vomiting scenario just outside the steps of the van or something like that, but then we've already got that regulatory problem we've talked about. But, I mean, the thing that I was thinking about with it was that we make the sentence here that it's essential It's scan in van type of thing at
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 scenarios. "facility." that the mobile service have access in the event of a contamination. That seems to me to apply from a radiation
safety standpoint that I've got to have access to their decontamination equipment, I've got to get their radiac wash, I've got to get, you know -MR. LYNCH: MR. CAMPER: That wasn't the intention. Well, then if a spill occurs in a
van, why is it essential to have access to the facility in the event of -MS. TAYLOR: We've hung up on the word
Let's get rid of that word and come up with
something better, then. MR. LYNCH: Well, we're talking about a mobile
service leasing space on client property. MS. TAYLOR: And it may actually involve a small,
little area within the hospital. MR. CAMPER: Let me think. Do you mean, then, by
this sentence, do you mean that this sentence says, then, that in the event of a spill the personnel of the mobile medical service has to be able to get into the van? You're saying
that there might be a problem because it's leased to the institution that they can't get in there? MS. TAYLOR: No, no, no. There are two
You can have a mobile service that has a van that
has leased property in the parking lot of the hospital, is
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 that, then. right next door to it, and the hospital provides patients and surrounding other facilities provide patients and they do their mobile service. You could also have the scenario -- and it hasn't come up, but I don't see why -MR. CAMPER: Wait a minute. Let's stay with
Let's say under that first scenario, now,
contamination occurs in the van. MS. TAYLOR: A hospital could feasibly say, "You
can't come on our property any more," and they need to have access to that van like -MR. CAMPER: Okay. So you're saying, then, that,
even though they've entered into a contract to lease the space, that the hospital could say, "You can't come into your scan van? MS. TAYLOR: If there's been disharmony and the That's what we're
contract doesn't allow them to, yes. looking for.
If you two have a fight and you have legal
problems and they kick you off their property but your van is still there, maybe you haven't been paying your rent. And if they kick you off and say "You can't come on until you pay all this back rent or we're taking possession of your van," you've got to have some kind of thing there so they can get in. And it probably isn't just contamination, I
could have said, but they need to have access to get to the
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 facility? MR. LYNCH: MS. TAYLOR: Yes, it is. Yes. Okay. So if it's commercial saying. material and get the waste out and -MR. CAMPER: Okay. Right. I see what you're
Your point is they have to have access to any
material, they have to have access to the van in the event of contamination. MR. LYNCH: Well, they're the responsible party
here for the health physics involvement. MEMBER WAGNER: MR. CAMPER: Yes.
Well, that's an interesting question
because if they were doing one of the services that the institution is licensed to do -MEMBER WAGNER: If the institution is licensed --
if it is not licensed, then they're responsible for it. MR. CAMPER: MEMBER WAGNER: MR. CAMPER: Clearly. Yes.
But if the institution, if the
hospital, is licensed, let's say 35.200 again, for sake of discussion -MR. LYNCH: facility here. MEMBER WAGNER: This is under commercial But we're talking about commercial
MEMBER WAGNER:
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 situations? of -MR. CAMPER: Well, yes. But in this case the Okay? But they have facility -CHAIRMAN SIEGEL: This is interesting because
this is really a contract issue, isn't it? MR. CAMPER: Yes, it certainly could be. I mean, this really is an issue
CHAIRMAN SIEGEL:
mobile service is a commercial entity. an arrangement with the hospital.
The hospital has a license.
XYZ Mobile Imaging Service, which is a commercial entity, if they go to the hospital, the hospital has a license, the same criteria in 35.29(d) applies. It doesn't matter whether it's a hospital that's doing mobile imaging, a private practice scenario that's doing mobile imaging, or a commercial entity, you know, Acme Imaging Company. If that hospital has a license, the criteria in
35.29(d) still applies. CHAIRMAN SIEGEL: MR. CAMPER: No. (d), about ordering? "Mobile nuclear medicine (c), "If a mobile
service may not order" -- excuse me.
nuclear medicine service providing services to clients is also authorized to provide a client with responsible" blah blah blah. MEMBER WAGNER: Yes. But doesn't that set up two
Doesn't that just simply set up the scenario
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 where if they're supplying services to a licensed institution, then they simply have to have access to their leased property in the event of a spill? MR. CAMPER: Right. The responsibility falls over to
MEMBER WAGNER:
the licensed institution to clear up any problems that occur in the institution. But if the hospital doesn't have a
license, if it doesn't have a license, -MR. CAMPER: Right. -- then you have to have access
MEMBER WAGNER:
to the hospital itself in the event that there is a need for radiation safety services inside the hospital. It's just those two situations. So just ask them
to clarify each situation and how they're going to handle it, what the contractual arrangement is. MR. CAMPER: Oh, you're saying, for example, if
the institution doesn't have a license and they're injecting a patient -MEMBER WAGNER: MR. CAMPER: Sure, right.
-- floor, for example? Sure.
MEMBER WAGNER: MR. CAMPER:
You're saying they have to have
access to the institution -MEMBER WAGNER: MR. CAMPER: Right.
-- for decontamination purposes?
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 at that. MR. CAMPER: No. And we do look at that. And we mean here. CHAIRMAN SIEGEL: When a mobile service adds a MEMBER WAGNER: MR. CAMPER: Right, right. So we need to clarify what we
Sure.
site of use, that requires a license amendment? MR. CAMPER: Yes. Okay. And do you normally
CHAIRMAN SIEGEL:
require to see the contracts between -MR. CAMPER: No. If you look --- mobile services --
CHAIRMAN SIEGEL: MR. CAMPER: No.
CHAIRMAN SIEGEL: MR. CAMPER: that's referred to. No.
-- and their clients? We look to see the letter
Mobile nuclear medicine services under
35.29(d), "The licensee shall obtain a letter signed by the management of each client for which services are rendered that authorizes use of byproduct material at the client's address of use. The mobile nuclear medicine service licensee shall
retain the letter for three years." MR. LYNCH: So we won't see that, but we do look
do look at that, but we don't see the contract. CHAIRMAN SIEGEL: specifically tell you that -But the letter doesn't
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 to do that? MS. TAYLOR: MR. CAMPER: contract, I mean. MEMBER WAGNER: the contract. No, no. You don't have to see To look at the contract. Oh, yes, if we want to see the 35. MR. CAMPER: That's correct. Would you have to change Part 35 letter. CHAIRMAN SIEGEL: Well, not without changing Part MR. LYNCH: No. It just says, "Acme Mobile
Service is authorized to do" -MEMBER WAGNER: You could ask for that in the
MEMBER WAGNER:
What I'm saying is you could ask for the
statement in the letter from management that they will provide access for the appropriate services. MS. TAYLOR: Well, that's what we've asked for,
"Submit documentation of the agreement in the event of disharmony." So we've asked for that in this paragraph. Oh, okay. Well, that's it, then.
MEMBER WAGNER: MR. CAMPER:
Yes.
In implementing -Although Part 35 doesn't really It's sensible
CHAIRMAN SIEGEL:
give you the right to ask for that; correct?
that you want to know how that would be handled. MR. CAMPER: I would put it a little -- I can see
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 why you would say that. What I would say, I would put a Clearly in the implementation of
little differently, though.
regulations you ask for things, you review things that one cannot find a specific reference to in the regulation. CHAIRMAN SIEGEL: MR. CAMPER: Right.
But that's part of implementation
because obviously if you covered every possible factual scenario in the regulation, it would be voluminous. So it
becomes an implementation interpretation issue on our behalf. CHAIRMAN SIEGEL: I guess I'm still a little
stuck here in terms of -- so what do you want to do with this? You want to -MR. CAMPER: Well, what I'm saying is I think we
need to be a little bit more specific in that, on the one hand, from a pure radiation safety standpoint, if a van is going to an institution and it's going to do scan in van, that mobile service should have the capacity to properly manage a decontamination event. Okay?
You should not have to run into the hospital and get their radiac wash and so forth, plastic bags to contain the chair that you use to clean up and so forth. By the same token, as Torre has pointed out, there is a need to ensure that that mobile service when it's in a contractual arrangement with a medical institution, that it always has access to the material and to the van. And that
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 disharmony. that van. CHAIRMAN SIEGEL: Have you all ever encountered a can be just deal with control of materials or it could also deal with the contamination scenario. we haven't mentioned. But the point is you've got to be able to get in And there may be others
situation in which the client did not permit -MR. LYNCH: Didn't one of the technical
assistance requests deal with -MS. TAYLOR: Well, it dealt with this scenario.
This is where it came up in the sense that it was leased property. It wasn't leading and going to different clients.
It was staying there, and clients were coming to them. CHAIRMAN SIEGEL: incident that involved -MR. LYNCH: MS. TAYLOR: get that information. CHAIRMAN SIEGEL: A spill with concomitant Disharmony? I'm not aware of any. I wouldn't But you've never had an
I've been wondering whether we're doing a thought
experiment or whether we really have any experience to draw upon. MS. TAYLOR: To be honest with you, the client
and the mobile service probably would have such a detailed contract to allow for all of these scenarios anyway just for
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 to be. legal reasons that -CHAIRMAN SIEGEL: Well, I would hope so, but, you
know, they may not be as clever as we think they are. MS. TAYLOR: Yes. I mean, I know that if
CHAIRMAN SIEGEL:
Washington University were doing this, the contract would make the NRC license look small by comparison because our lawyers are pretty careful, very plodding, and think of everything. And I think most hospitals these days are smart enough to know that when they hire independent contractors to do these sorts of things for them, that they think carefully about OSHA requirements and EPA requirements and local safety requirements and a variety of things and NRC regulations. And they build that onto the contract and figure out a way to make sure that neither party is going to be in violation, number one; and that, number two, that it clearly spells out whose rear end is on the line in the event there is a violation. And that's always pretty carefully subdivided.
I see this as less of a real issue than it seems And I guess the sentence "in the event of disharmony,"
would it be better just to figure out a way to say "Describe the arrangements for dealing with incidents"? MR. CAMPER: and incidents. CHAIRMAN SIEGEL: Right, that occur on either Yes, access and control of material
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 Okay. The term "base hot lab," the main facility from -- I'm looking at the definition now, "the main facility from which the mobile licensee operates." What does that mean? neutral. MR. LYNCH: Well, we already do that. We say, leased property or in the client's facility. MS. TAYLOR: MR. CAMPER: It might work. Yes. Just kind of make it one
CHAIRMAN SIEGEL:
"Include provisions for access of decontamination by the mobile service." MS. TAYLOR: Yes, but he's wanting to get rid of
that description of "in the event of disharmony." MR. CAMPER: Right, right. Because that's a very
CHAIRMAN SIEGEL:
theoretical sort of "Now, what would I do if I wasn't talking to my landlord?" It's hard to write that when you're
currently talking to the guy. MR. LYNCH: I don't think we lose too much if we
just strike that sentence out. CHAIRMAN SIEGEL: MR. CAMPER: I agree.
And, again, that keeps us focused
upon the radiation safety issues. CHAIRMAN SIEGEL: The radiation safety issue.
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 now. MR. CAMPER: What it means historically is that MR. CAMPER: historically. CHAIRMAN SIEGEL: I'm at the glossary in the back Well, I can tell you what it means
these mobile imaging scenarios have typically had a fixed office, often in an industrial complex, sort of a low-lying industrial complex. They do all their administrative billing, And they have a receipt scenario
et cetera, from that point. set up.
They have prescribed their procedures for receiving their doses and so forth. At that facility
sometimes they have generators, they're preparing their doses there. And they then load the material onto the van. And they depart from this base hot lab operation and go out and about and service their client. CHAIRMAN SIEGEL: Is that common practice in 1995
or is it more common for the van to move around while Syncor is delivering the doses to the client? MR. CAMPER: I think it's still common practice,
but I think it's becoming complicated by the fact that commercial radiopharmacies are increasing their delivery networks and are better positioned to provide materials to a van.
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 Let's say, for example, a van leaves its base hot lab operation, drives 20 miles away to a town populated by, let's say, 8,000 people. It's now there. It's providing
services to the hospital in that town.
It wants to stay there
overnight because the next day it's going to provide services. What we're finding is that the commercial radiopharmacies are now better capable to deliver materials to that town, that population of 8,000, to that van. Then you get into a situation. Let's say that
that van is going be there for 2 or 3 days because 4 miles away there's a town of 3,000 people and patients are being ambulance-brought to the van. Now, under that scenario with the van sitting in that town of that population for three or four days, it becomes a lot like a base hot lab. CHAIRMAN SIEGEL: MR. CAMPER: Yes.
It's still got its primary corporate So it's changing. And the
facility back here somewhere.
reason it's changing is because of the network deliver for radiopharmaceuticals is different today than it was 10 years ago. CHAIRMAN SIEGEL: So what is typically happening
with waste disposal in the scenario where the van sits at this place for three days? MR. CAMPER: Well, that raises another
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 disposal. disposal. MR. CAMPER: That's right, being held for interesting question because you start getting into the question: -CHAIRMAN SIEGEL: on the highway. MR. CAMPER: Right. Put it on the side. Put it on the back of a truck Now, what do you do about waste? For example, if I
So if I make two or three injections during the day and I now have a couple, two or three, spent syringes and I want to keep it on the van overnight because the next day the commercial radiopharmacy is going to come and pick it up, is that temporary storage? Is that classical disposal?
I mean, as you know in a medical setting, in an institution setting, we do that all the time. sit there. Spent syringes
The next day they come and pick up the suitcases We haven't disposed of it, haven't It's just it's part of the use
and take it away.
necessarily stored it either. cycle. CHAIRMAN SIEGEL:
They're being held for
So you can argue that's part of the use cycle. MEMBER WAGNER: But I think that we have to
consider on those things -- go right back to the radiation safety issues. I mean, these do not constitute a tremendous
radiation safety issue.
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 with. MR. CAMPER: And, as Torre said, we do grant problem. MS. TAYLOR: little further. to -MEMBER WAGNER: And now you want to make sure And we got into that when we got a MR. CAMPER: No, of course not. I can't see that there's a
MEMBER WAGNER:
And we also have allowed several exemptions
that they don't leave the daggone thing open overnight for anybody to come in and -MR. CAMPER: It's a control issue. Sure.
MEMBER WAGNER: MR. CAMPER:
It's a control issue. Sure. It's very simple to deal
MEMBER WAGNER:
exemptions to allow this type of thing to take place. CHAIRMAN SIEGEL: MR. CAMPER: I understand.
But, anyway, getting back to his, I
was just trying to explain this base hot lab, what has classically and historically been, but you can see that, again, the way things are changing -CHAIRMAN SIEGEL: concept now an archaic one? MR. CAMPER: So maybe is the base hot lab In a way, isn't it really better? It's still
No, it's not archaic.
being done in a lot of the scenarios.
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 CHAIRMAN SIEGEL: But wouldn't it be better to
say for each site of use of byproduct material proposed by this mobile service, which could include a base hot lab as well as each and every client, describe how byproduct material will be received at that site, how byproduct material will be used at that site, and how byproduct material will be disposed of at that site? MS. TAYLOR: I don't think we get that specific. But I may be suggesting that in
CHAIRMAN SIEGEL:
order for you all to evaluate whether this license arrangement is a good arrangement. Now, you could say, I mean, that could
be collapsed to one paragraph that says "The way we do it is we receive everything at Point A, we carry it to Points B, C, D, E, and F, and at the end of the day we carry it back to Point A and that's where it's disposed of." And then you've done, you've captured what I just did in one paragraph. But if there was a different
arrangement at each of nine different client sites, you'd want to know what each of those arrangements are. MR. CAMPER: Well, let me just bring to bear a
point I made in my opening remarks with regard to a couple of big issues that I see. And one is this idea that if you ask
someone to describe what you just said, they may well describe a scenario which would warrant an exemption to either 35.29(b), which says "The mobile nuclear medicine service may
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 not order byproduct material to be delivered directly from the manufacturer or distributer to the client's address of use," because you might as a mobile service be able to describe an arrangement whereby your van would be at Hospital A. Personnel would be there to receive. An arrangement could be put in place with the hospital that when the material is delivered there, it's clearly instructed the security guard picks it up, signs for it, takes it to your van. receive it and so forth. In other words, what I'm saying is that I can imagine a mobile service being able to describe such a scenario. 35.29(d). CHAIRMAN SIEGEL: of 35.29(d)? MR. CAMPER: I think that -- again, it's a little What is the historical source Okay? But that would require an exemption to Your personnel are on site to
hard to kind of be in the minds of those who went before you, particularly the statement of consideration on a particular -but I think the thinking at this day and time is that mobile services were sort of a stepchild of medical institutions, if you will. In other words, the institution was the preeminent -- that and the authorized user were the preeminent entities as far as licensing was concerned in the medical
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 license. MS. TAYLOR: I think when this regulation was scenario. Mobile services being provided to it, okay. Yes.
You're providing a mobile service, but that institution is still in control. And, really, a mobile nuclear medicine service is not in the position to be able to describe or create a scenario whereby materials can be delivered to that institution and, therefore, that allow that to happen. And I think that today those business arrangements and the sophistication of those mobile medical services could put in place such a scenario. MS. TAYLOR: The other issue is that some of So, obviously,
those clients may not have an NRC license. they couldn't receive -MR. CAMPER:
Well, that's a good point.
Some of
them may not be able to, period, -MR. LYNCH: MR. CAMPER: A lot of them don't. -- because they don't have a
probably written, that was probably the most typical scenario. And now you've more facilities. And it may go back to that
with the cost of maintaining a license. MR. CAMPER: receive it at all. Right. Well, it certainly couldn't
That's a good point. Previously it was not allowed. If
MR. LYNCH:
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 35.80. think, -MR. LYNCH: MS. TAYLOR: MR. CAMPER: MS. TAYLOR: Yes, we do. -- when we talk about -Yes. -- provisions if the client hasn't I think we do the institution had a medical license, a mobile service couldn't provide the service to that institution. MR. CAMPER: now, you can't. Well, the way (d) is written right Even if the institution has a
That's right.
license, it just simply says, "Distribute to the client's address of use." client. Now, in Torre's point, if it's a non-licensed client, they can't receive materials, period. contrast, I mean, a licensed institution could. MS. TAYLOR: And we get into that a little bit, I But, by That can be a licensed or non-licensed
had maybe a formal transfer or what have you. address that. CHAIRMAN SIEGEL:
Can a mobile nuclear medicine
service under 35.29(d) order byproduct material to be delivered directly from the manufacturer or distributer to the mobile service's address of use at a client site? MR. CAMPER: No. It requires an exemption from
It requires an exemption from 35 -CHAIRMAN SIEGEL: So the way this is currently
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 tougher. MR. CAMPER: But the point I was making was -What I set up, there either has to be either the client has to have a license or there has to be a base hot lab? MR. CAMPER: MR. LYNCH: Either that or an exemption. Or an exemption. Or an exemption.
CHAIRMAN SIEGEL: MR. CAMPER: MS. TAYLOR:
See, to do what you just said -Which we have allowed to have
material delivered to the van. MR. CAMPER: That's right. To do what you just
said requires an exemption of 35.80(a), which says, "The mobile nuclear medicine service shall transport to each address of use only syringes or vials," blah blah blah. And
the reason it specifies only syringes or vials, because you can't do it with generators, although we will grant an exemption for that as well. But the point I was -CHAIRMAN SIEGEL: have to drive fast. (Laughter.) MS. TAYLOR: Well, those exemptions are -And with 0.15 water, it's even Going across Montana you really
CHAIRMAN SIEGEL:
and we kind of got into some basement-level details.
was really saying is if it's appropriate to ask for some of
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 I'm just -CHAIRMAN SIEGEL: I just think that in a way it's the descriptions that you were suggesting, -CHAIRMAN SIEGEL: MR. CAMPER: Yes.
-- which I think is a good idea, by
the way, but if you do that, I think that part also needs to bring to the attention of the applicant that some of these receipt scenarios may require you to obtain an exemption of 35.29(d) or 35.80(a) because if they're going to scribe in the detail that you were suggesting, some of those things will absolutely mandate an exemption. On one hand, you have a good -CHAIRMAN SIEGEL: MR. CAMPER: But that's okay. It's okay. It's fine.
Well, no.
better to just be very direct and say, "Just tell us how you're going to do it." MR. CAMPER: I agree. And all I'm saying is that
someone out there today if an applicant -CHAIRMAN SIEGEL: achieve clarity of thinking. MR. CAMPER: Yes. But, I mean, if you're, on one At the risk of trying to
hand, going to describe clearly what it is that you're going to do, which is obviously a good idea, I'm only saying to make them aware of that. And guess what? In doing that good idea
and giving us that good detail, you might have to exempt, seek
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 house, -location. MS. TAYLOR: So this is information that we would And we really don't -an exemption, which is fine. CHAIRMAN SIEGEL: MEMBER WAGNER: base hot labs. Well, that -I had one issue with the issue on I put a bunch of
It's Number 4 on Page 8.
question marks by this one, "Submit confirmation in the form of letters from local agencies that operation of the base hot labs does not conflict with local codes and zoning laws. Include confirmation in the form of a signed statement by the licensee that police and fire departments with jurisdiction in the area shall be notified of byproduct material content initially and at 12-month intervals." MS. TAYLOR: This is under a residential -I thought physicians are
CHAIRMAN SIEGEL:
required to do essentially the same thing. MS. TAYLOR: you look up at (c). MEMBER WAGNER: MS. TAYLOR: (c)? This is under a residential use. If
There have been requests to operate
from a residential location. MEMBER WAGNER: Right. This is a residential
want applicable to that scenario. MR. LYNCH:
If you're doing this out of your
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 this. MEMBER WAGNER: MR. LYNCH: Yes, right.
-- we want to make sure the zoning is
appropriate for it and -MEMBER WAGNER: reasons for the request. I understand. I understand the
I also can perceive of it being I'm not sure,
difficulties with some of these things.
"Include confirmation in the form of a signed statement by the licensee that police and fire departments with jurisdiction in the area shall be notified of byproduct material content initially and at 12-month." want them to have? MS. TAYLOR: Well, the nuclear pharmacies do What kind of notifications do you
You sign a letter saying that they have been notified
of what you have in that facility in the event of a fire. MEMBER WAGNER: CHAIRMAN SIEGEL: MEMBER WAGNER: Yes. Your institution does it, too. I know that, but I'm thinking of I can
these small fire departments out in certain facilities. tell you they don't know anything about radiation. talked to them. They know nothing about radiation. I've
MR. LYNCH:
Well, the intent is to inform them Should
that "We have hazardous materials in my basement here. there be a fire at this address," -MS. TAYLOR: MR. LYNCH: Yes. "Beware of that."
-- "here is what you need to do.
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 of that. MEMBER WAGNER: I was just trying to get at what Here are the numbers to call." MEMBER WAGNER: MR. CAMPER: All right. We don't get into: How
Yes.
qualified is the fire department to deal with -MEMBER WAGNER: MR. CAMPER: No. I understand that.
Our approach is to make them aware
we're trying to achieve by all this notification and stuff because -CHAIRMAN SIEGEL: for residential -MS. TAYLOR: MR. CAMPER: Right. Yes. -- base hot labs? Have there really been requests
CHAIRMAN SIEGEL: MS. TAYLOR: MR. CAMPER:
One that I'm aware of. Yes. And it was permitted by the
CHAIRMAN SIEGEL: local zoning laws? MR. LYNCH: MS. TAYLOR: MR. CAMPER:
There's one in St. Louis. Probably your next-door neighbor. It's next door, yes. It's my house.
CHAIRMAN SIEGEL: (Laughter.) MR. CAMPER:
It's your neighbor, your next-door
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 this? neighbor. MS. TAYLOR: out probably in -CHAIRMAN SIEGEL: One block away from Washington Well, I think most of them are set
University's temporary decay and storage facility, but they do a good job. So it doesn't bother me. There's a residential base hot lab in St. Louis? MR. LYNCH: Yes, yes. Incredible. Okay.
CHAIRMAN SIEGEL: MEMBER WAGNER:
"Verify that restricted areas I hope so.
should not include residential quarters." MR. CAMPER:
While you're at that part there,
too, I had a question on 3, just above that, again this idea -- and, Jim, maybe you can shed some light on this -- "Submit an evaluation demonstrating compliance with 20.1301." So
we're saying we want somebody in a residential scenario to do that. My question was: Do all licensees have to do
Because if you go look at 20.1301, 20.1301 is an This is the one that says, "You
absolute regulation standard.
will limit your doses to members of the public to 100 millirem. 2 mr." MR. LYNCH: Yes. Commercial pharmacies have to And doses in the unrestricted area will not exceed
deal with that question.
Who's on the other side of the wall?
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 by some -MS. TAYLOR: Right. You can come in and do a quick CHAIRMAN SIEGEL: MR. LYNCH: So does everybody.
We're going to put a TLD on the wall
to ensure that the dose on the other side is below regulatory limits, that sort of thing. MR. CAMPER: referring to. MEMBER WAGNER: Or you could have a survey done So that's the evaluation that we're
MEMBER WAGNER:
survey and to verify that the exposure rates are so low that no one could possibly -MR. CAMPER: Well, that's fine. I understand.
CHAIRMAN SIEGEL: redundant here? MR. CAMPER: MR. LYNCH: application. MR. CAMPER: be asking for something.
So you're saying this is
Well, it's either redundant -It is required on any license
The impression I had was we seem to When we say "Submit an evaluation
demonstrating," we seem to be asking for something here that's different or above what we're routinely expecting to see licensees demonstrate to show compliance of 20.1301. MS. TAYLOR: We could just say "Demonstrate
compliance or describe how you're going to demonstrate
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 point. MEMBER WAGNER: residential and not others? MS. TAYLOR: MR. LYNCH: Just to make sure. I mean obviously in a residential Why is it being singled out for compliance" or -MEMBER WAGNER: that in Part -MR. CAMPER: But we're just pointing -Why is it being singled out for Why is it -But don't they already have to do
MEMBER WAGNER: residential and not others? MR. CAMPER:
Well, that's another interesting
situation you have potentially on the other side of a wall somebody spending a great amount of time, 20 hours a day, as opposed to a commercial facility, where that would likely be limited to less time than that. So it was an attempt to bring
out that concern a little bit here. CHAIRMAN SIEGEL: Now, Paragraph 2 probably
should be altered along the same lines that we suggesting altering it for client. scenario. I guess this is where you're talking about you're leasing an apartment in an apartment building as your base hot lab. MS. TAYLOR: I don't think we can do that. It's dealing with a fairly uncommon
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 authorized. CHAIRMAN SIEGEL: and licensee." Well, it says "residence owner CHAIRMAN SIEGEL: I just can't imagine. I can't
imagine the tenants in the apartment building sitting still for that. MS. TAYLOR: That probably wouldn't be
I guess it could be a man and a woman living
together who are not married and one of them runs the base hot lab and the other is the residence owner. MEMBER WAGNER: We had a physician who wanted to
rent the apartments in a -- or, actually, motel rooms -CHAIRMAN SIEGEL: MR. CAMPER: You've thought of everything.
We try. -- as his place to put his
MEMBER WAGNER: therapy patients.
He wanted to rent a motel and put patients
in the motel for confinement. CHAIRMAN SIEGEL: MEMBER WAGNER: MR. LYNCH: with 1301 there? Oh, God. All right.
We had that situation. Why did we decide
So I don't know.
Do we want to -I'd be inclined to delete it
CHAIRMAN SIEGEL:
since it's part of every license application unless you meant that it was -MR. CAMPER: Well, that's the thing I was --- at a higher and higher
CHAIRMAN SIEGEL:
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 that. MR. CAMPER: Well, as I read it -- and maybe I level. MS. TAYLOR: Okay. I don't have a problem with
misread it, but I got the impression that we were seeking some evaluation demonstrating compliance that's distinctly different than what we would expect under normal circumstances. MR. LYNCH: No. It's just that in a residential
setting, it has a little different flavor. MR. CAMPER: And even then we're looking for
presentation in a program that demonstrates compliance with 20.1301, not necessarily an evaluation demonstrating compliance. In other words, we're looking to see that they're
going to give us a program that would appear to meet the intent of 20.1301 that the operation will not cause an exposure to greater than 100 millirem. MR. LYNCH: You're right. But I believe the evaluation --
MEMBER WAGNER: MR. CAMPER:
But we don't say, "Show us that you
evaluated your program so that that won't happen." CHAIRMAN SIEGEL: You could change this to say
something like, "Submit a description of your program demonstrating how you will achieve compliance with 20.1301" -MR. LYNCH: We do that elsewhere.
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 ask -CHAIRMAN SIEGEL: has to be calculated. MEMBER WAGNER: Correct, correct. But it still Well, until you're licensed, it true. CHAIRMAN SIEGEL: mind the emphasis here. That would be okay. I don't CHAIRMAN SIEGEL: -- "in a residential setting."
And you're just trying to emphasize that it's more difficult to do so in a residential setting. MR. CAMPER: In a residential setting. That's
I'm actually flabbergasted that
anybody is going to do this in a residential setting. MR. CAMPER: Yes. I think that's a good point
MEMBER WAGNER:
because I think evaluation, I think evaluation, if I recall this correctly, can be calculations. MR. CAMPER: Yes, it can. And so here you may be wanting to
MEMBER WAGNER:
may be ongoing calculations that you can present without any real measuring data. And it might be here in the residential
setting that you may actually want to measure, have some real data that you would evaluate. MR. LYNCH: Well, certainly our inspection I mean, that would be a key
process would look at that.
aspect of the inspection to determine whether the 1301 is met.
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 word. MEMBER WAGNER: CHAIRMAN SIEGEL: MS. TAYLOR: Really, I agree. No pun intended. it is. CHAIRMAN SIEGEL: I mean, it's an inflammatory "hot"? MR. CAMPER: as in "base hot lab"? Yes, I can see your point. That's common nomenclature. As in "base hot lab." Yes. I know, but that -- I know You mean CHAIRMAN SIEGEL: MR. CAMPER: All right.
So we're flipping to Page 9. Temporary job sites. Oh, I
CHAIRMAN SIEGEL:
actually have a question about two jargon terms, "base hot lab" and "scan in van." MR. LYNCH: Those are all but -Is "hot lab" really the term we
CHAIRMAN SIEGEL:
want to be using in a regulatory document? MEMBER WAGNER: Why don't we take out the word
CHAIRMAN SIEGEL: MEMBER WAGNER:
What's the other lingo out there? Base laboratory.
MEMBER WAGNER: MS. TAYLOR: MR. CAMPER:
Base laboratory? Well, is it a base
radiopharmaceutical laboratory? CHAIRMAN SIEGEL: That would be okay.
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 word. MS. TAYLOR: Let's do that. That would be fine. And then if you're going to do
MEMBER WAGNER: CHAIRMAN SIEGEL:
that, make it "laboratory," instead of "lab," which is also jargon. MEMBER WAGNER: CHAIRMAN SIEGEL: "Hot" implies -MEMBER WAGNER: CHAIRMAN SIEGEL: I agree. -- by in these formal Yes, right. I just think a non-pejorative
regulations that we're making a judgment about them. MR. LYNCH: not a regulation. MEMBER WAGNER: MR. LYNCH: Still. This is a regulatory guide. This is
It's meant to speak to the -Sure. And then this "Jack in the box
MEMBER WAGNER: CHAIRMAN SIEGEL:
service" we're talking about -MR. CAMPER: But the point, though, even if it's
a guide, there's a way to describe what it is and not do it in an inflammatory manner. CHAIRMAN SIEGEL: MS. TAYLOR: You could --
Politically correct; right? -- have "highly dangerous base
CHAIRMAN SIEGEL:
hot lab" while you're at it, too; right?
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 -MR. CAMPER: And by definition it is a MEMBER WAGNER: We have those. We have different
radiopharmaceutical laboratory. MEMBER WAGNER: MR. CAMPER: the kind of thing. CHAIRMAN SIEGEL: a better way to describe? MR. CAMPER: "Scan in van"? You could put it -- well, I think "Scan in van service," is there Right, right. So that's
It is based in nature.
MEMBER WAGNER:
that's a term that's used -CHAIRMAN SIEGEL: MEMBER WAGNER: MR. LYNCH: Mobile imaging service or -No.
Well, see, it's not -"Scan in van" is such jargon.
CHAIRMAN SIEGEL: MR. LYNCH:
It is a -It's Jack in the box. It's
CHAIRMAN SIEGEL: right at that level. MR. LYNCH: MS. TAYLOR: Yes.
We didn't like that either.
Well, maybe we could just say
"Indicate if only imaging service will be provided with" -MEMBER WAGNER: imaging service"? MR. CAMPER: "In-van imaging," yes. Why don't we just say "in-van
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 feature. MR. CAMPER: I'm showing about 9 after 10:00. Do Thank you. MR. CAMPER: (Laughter.) CHAIRMAN SIEGEL: non-service." You can have "imaging Texas is heard from. MS. TAYLOR: Oh, that's good. Bless your heart, Doctor. So
CHAIRMAN SIEGEL:
leave the hyphen with the word "in-van." MEMBER WAGNER: CHAIRMAN SIEGEL: "In-van imaging." "In-van imaging service."
I'm not going to let you escape on that one. I'm glad I didn't have anything to
MS. TAYLOR: do with that one.
CHAIRMAN SIEGEL: MEMBER WAGNER:
Okay.
Good.
It will have to be changed
throughout the document, too. MS. TAYLOR: Yes. I'm glad for the REPLACE
you want to break at about -CHAIRMAN SIEGEL: MR. CAMPER: to break now or -CHAIRMAN SIEGEL: MR. CAMPER: Yes. Let's do it. Yes, I do.
-- 10:15 or something or do you want
You want to go now? Yes.
CHAIRMAN SIEGEL:
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 van. MR. WAGNER: Why in the world don't you just take MR. CAMPER: All right. This is a break.
(Whereupon, the foregoing matter went off the record at 10:05 a.m. and went back on the record at 10:32 a.m.) CHAIRMAN SIEGEL: Are we okay? We are on temporary job sites.
I didn't have anything there other than the
"scan-in-van" jargon. MR. WAGNER: MS. TAYLOR: MR. WAGNER: I guess we were on page 9 and 10. Right. Temporary job sites, okay. Was there anything substantive
CHAIRMAN SIEGEL: on either of those? MR. LYNCH:
If you will note, in here we bring up
the paragraph about 1301 again, 20.1301, Item 3. MR. WAGNER: MR. LYNCH: Right. Again, we're just trying to be -Reemphasize.
CHAIRMAN SIEGEL: MR. LYNCH:
Reemphasize. Well, maybe you ought to just
CHAIRMAN SIEGEL:
add a similar parallel phrase. MR. LYNCH: Well, we are saying it's outside the
this and put it at the beginning? MS. TAYLOR: Because --
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 about, yes. Number 4. beginning? MR. WAGNER: MS. TAYLOR: It doesn't matter. Chances are, that might be addressed I'm not sure, and these are important. MS. TAYLOR: Oh, you're saying at the very, very MR. WAGNER: MR. LYNCH: Just put it at the beginning. Well, the point is we could not
include it at all, if that's the desire. CHAIRMAN SIEGEL: reemphasized. MR. WAGNER: It's a minor point. It's not Well, I don't mind seeing it
in the body of 10.8 already. specific things -MR. WAGNER: MS. TAYLOR: MR. WAGNER: MR. CAMPER:
Just reemphasis. Yes. That's fine.
That's fine.
It's not a problem.
I had the same concern here that
I've expressed several times before, and it's this 35.29(c) issue, if they are doing the same services, so forth and so on. It may be that we'll cover that somewhere up front, as
sort of general administrative guidance. MR. WAGNER: I have a lot of problems on page 10,
Did I interrupt you there? CHAIRMAN SIEGEL: That's what Larry is talking
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 that. licensed. MR. CAMPER: Also, back on page 9, though, the
sentence where it says "Indicate if 'scan-in-van' services will be provided. Note that your service may not be
considered licensed activities if you are only providing services for scanning patients." clearly. MR. WAGNER: Imaging. Well, I guess you want to We could say that more
say scanning, imaging or -- I guess it could be more than just imaging. MR. CAMPER: Well, it may not be considered
It may not be considered licensed activities, if
you are only providing... -MS. TAYLOR: Well, and then we go on to say, "In
situations where radioactive material is not handled by the mobile medical service an NRC license may not be required." Instead of saying handled, we may want to say possessed and used. MR. CAMPER: Yes. We need to be a little more
explicit about what we are getting up there. CHAIRMAN SIEGEL: Some sort of clarification on
I don't know exactly the words, but -MR. WAGNER: Although I can't imagine that being
the case, because they would have to have -- They would have to have a Cobalt 57 flood source. of -They have to do some kind
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 MR. CAMPER: MS. TAYLOR: We don't regulate it. We don't regulate that, but there Do we have
are probably other sources they would need also. anyone like this?
The other thing is, if they go to the
facility with their van in which they could use those sources under their supervision and do all their QA -- So they wouldn't have to possess the sources. MR. WAGNER: Yes, they could do that. If they
just have the camera or they have a thyroid uptake probe or they have -- It just doesn't have to be imaging either. That's the other caveat here, is that it doesn't have to be just imaging. It could be quantitative studies. MS. TAYLOR: MR. WAGNER: That's true. You could have quantitative studies.
It isn't just limited to imaging. CHAIRMAN SIEGEL: Do we know if anybody is doing Thyroid uptake probes
that, if people are transporting any.
are sufficiently inexpensive that, if you really want to provide this service, it's not that big a deal for the hospital to do it, unless it's a matter of not wanting to have a license at all. Okay.
So are we aware that scan-in-van exists with no licenses of any sort, simply transporting camera from site to site? MS. TAYLOR: Well, I'm thinking it must, because
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 exists. this is information that came from the current policy guidance directive that's being used with this year's -CHAIRMAN SIEGEL: Well, I'm sure scan-in-van
The question is whether it exists unlicensed, because
the mobile service never actually has anything other than a radioactive patient who walks into the van. MR. CAMPER: Let's say -- That's an interesting Let's say someone
question for sort of a different reason.
was very astute, who really understood the regulation, and they recognized they could do that absent the license. wouldn't know it unless the licensee, the hospital, had We
indicated in their application somewhere that patients were being scanned on this van and that they wanted to inform us, you know, that this was another place of use, not within the boundary of the building but otherwise. literally know it. CHAIRMAN SIEGEL: Well, no, you might know about We might not
it, though, because someone who is doing it might be clever enough to pick up the phone and say, this is what I'm planning on doing, and I want to make sure that you all don't see any problems with it. MR. CAMPER: and decide he didn't -CHAIRMAN SIEGEL: They might be exceedingly cover Okay. Right, or he might be very clever
and say, the hell with you, I don't have to have it.
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 really. MR. CAMPER: It's saying that you're going to MR. WAGNER: On Item Number 4 -Are we on page 10 again? Is the intent of this rule to
CHAIRMAN SIEGEL: MR. WAGNER: Yes.
say that the client is responsible for the radioactive materials on their site or does it really mean that the client is responsible for radiation safety on the mobile van itself, in addition to the mobile people being responsible for what's going on in the mobile van? MR. CAMPER: Well, it's saying -- If you go back
to 35.29(c), it's saying that the institution, the hospital, is responsible for assuring that services are conducted in accordance with the regulations in this chapter while the mobile medical service is under the client's direction. other words -CHAIRMAN SIEGEL: It's setting up a hierarchy, In
ensure -- you're the hospital, and you're going to ensure that the regulatory conditions are met while that van service is at your facility providing those services. MR. WAGNER: So, basically, what it's saying is,
if I as the hospital -- If I go in and I say, okay, you people are here to do this scanning, but I have to make sure you're doing this in compliance with the regulations, what are you doing. What are your practices? Do I have to verify that
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 they're going to be doing things appropriately? go down there and inspect them. Do I have to
What do I have to do, because
they're the ones that have been doing this all the time. Presumably, they have a license. CHAIRMAN SIEGEL: Well, that's exactly what it
means, because this is -- The mobile service is functioning as an independent contractor providing service to a licensed institution. Therefore, the institution's management has the
ultimate responsibility for the licensed activity. Actually, even though I can think of objections from a purely business point of view, I think from a safety point of view, this is a better hierarchical structure. puts the ultimate responsibility on sort of the bigger organization, what would generally be the bigger organization, what would generally be the organization with a broader set of overall responsibilities, deeper pockets perhaps. MR. LYNCH: If you look at 35.25, which the It
hospital would be required to follow, it says periodically review the supervised individuals, use of byproduct materials and the records kept of that use. to require some -MS. TAYLOR: MR. CAMPER: Well, that's true. The answer to your question from a So that regulation is going
practical standpoint is that, yes, they are going to have to go out there and keep an eye on what's being done. They're
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 to do it. problem? going to have to monitor it. They're going to have to take a
look and see if appropriate records are being kept, so forth and so on. CHAIRMAN SIEGEL: Now again, is this a big
Are there lots of these arrangements? MR. CAMPER: Well, let me just put it this way. Where both have licenses?
CHAIRMAN SIEGEL: MR. CAMPER:
We just had -- The answer is, no,
there are not lots, but we just had an exemption request from a mobile medical imaging situation. They requested an
exemption to 35.29(c), and their rationale for it was that we are offering this as a business service; we want to and intend to control all aspects of the radiation safety program associated with this service, all aspects of its use, and we don't want to be in a situation where we find ourselves either in conflict with the medical institution which we're providing service or an absence of an adequate level of service or support or monitoring by that licensee. it. We want to oversee it. MR. WAGNER: MR. CAMPER: MR. WAGNER: MR. CAMPER: MR. WAGNER: I agree totally with that. And we granted an exemption. Okay. Yes. To me, that would be a sensible way They granted the exemption? We want to control
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 flux. license. MR. CAMPER: That's right. They're in a stage of I'm sorry. CHAIRMAN SIEGEL: institution have a license? MR. CAMPER: Because they either have Again, let's take 35.200 Why does that medical MR. TAYLOR: MR. CAMPER: I haven't been to OGC yet. We intend to grant the exemption.
historically wanted to use material. as an example. reason.
They have wanted to do that for whatever
They may still have a license, but have decided to
use the services of a mobile service, because maybe it's cheaper or maybe their operating parameters have changed. don't know. MR. TAYLOR: MR. CAMPER: They may not have a user. They may not have a user, but they I
want to keep being able to image patients, but the question that it raises in my mind -CHAIRMAN SIEGEL: they don't have a license. MS. TAYLOR: MR. CAMPER: They could be -CHAIRMAN SIEGEL: Well, it can't be an active Well, they still need it. They could still have a license. But if they don't have a user,
They still have a license, though, by definition, but
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 ways. getting back to the point you were raising, the thing that I'm struck by as I was looking at all this, you know, the question is, if you're going to issue a license to a mobile medical service -- We have historically sort of had this -- If one reads these regulations, you get this parent/child feeling -right? The medical institution is the parent. The mobile is
the child. I guess the question you have to ask yourself is, if you assume that in 1995 mobile medical imaging is changing, provision of service are changing and so forth and so on, is it appropriate, is it necessary for us to place the same level of responsibility and burden on a mobile medical imaging service that we expect of an institution with regards to radiation safety and control and use of materials and so forth? That's something I think we need to explore, as we revise Part 35. Obviously, that would require a rule
change, but it's something we need to ask ourselves as we look at it. MR. WAGNER: I mean, I can see this going both
I can see where a small service company would come in,
and they would want the radiation safety services of the larger institution when they get on their site. I mean, I can
see where they would want that, because they are a small company, and they don't have the depth to manage some things
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 would. MR. WAGNER: If they are coming into my or the other situation is where they want to be independent of the person because of this very problem. This could be a terrible conflict. MR. CAMPER: Well, sure it could. Let's imagine
that you're -- Let's say you're a very sophisticated physicist and in a very sophisticated position. perform, you know, mobile imaging. conscientious. You understand radiation safety, understand the regulations, but now you're going to go provide your services to a hospital in a very small community in a very outlying area that's not terribly sophisticated when it comes to radiation safety. MR. WAGNER: MR. CAMPER: But they got a license. But they got a license. You may You and Barry decide to
Now you are both very
well want to control and be able to monitor all aspects of radiation safety. MR. LYNCH: I think in most cases, the mobile
service does follow all the way through. MR. CAMPER: Yes, I think you're right. MR. LYNCH: But if they are coming into your
institution, do you want to have any control over them? CHAIRMAN SIEGEL: Sure you do. Of course. I
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 right now. MR. WAGNER: Yes. We're stuck with this Part 35. institution, that's one thing. If they are providing services
within their van, and it's confined to the use inside their van, that's another issue. As soon as the patients walk out
of there, I'll take responsibility for them, although I don't have any legal requirement to do that, because they are all diagnostic patients; but I expect them to manage the things inside their van. If I go in there and try to tell them they're not doing something right, and they are doing the services and they are in conflict with me, I can see where that creates a problem. CHAIRMAN SIEGEL: Well, we're stuck with this
CHAIRMAN SIEGEL:
We're stuck with it right now. MR. WAGNER: Yes, we're stuck with it, but I
think that's the reasonable way of dealing with it, is asking them for the information and then making the decision based upon the individual request. So I don't see any problem.
MR. CAMPER: Well, and at this point, I mean, the best we can do is get a clear delineation of the arrangement. MR. WAGNER: MR. CAMPER: MR. WAGNER: Yes, right. Who's doing what. Right.
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 CHAIRMAN SIEGEL: The simplest solution to this
problem for a small medical institution that uses a mobile service is to get rid of its license and not have a license. Right? service. MR. CAMPER: Yes, and again it would not surprise There's two movements that I sense Then the mobile service is responsible for the entire
me if we see that happen. going on.
One is I see a consolidation of licenses among Possibly
small entities that have some corporate arrangement.
some nuclear medicine department is closing, using a more central location, and I also see mobile services as emerging. MR. LYNCH: MR. CAMPER: Then there's a fee issue. Right. Okay. Page 11, transport of In the middle of that
CHAIRMAN SIEGEL:
radioactive material and purpose.
paragraph it says, "Transportation of generators is not authorized by 35.80, other than for base hot lab locations." MS. TAYLOR: We missed that. That's not English, is it? We must have had two thoughts We just need to say transportation
CHAIRMAN SIEGEL: MS. TAYLOR: No.
going and didn't fix that.
generators is not authorized, period. CHAIRMAN SIEGEL: Because a base hot lab,
presumably, is not mobile, is it? MR. WAGNER: Could be.
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 question. MR. CAMPER: What I mean is this. Let me tell MS. TAYLOR: Could be, but normally they still
wouldn't be able to transport generators -CHAIRMAN SIEGEL: transport it. Okay. But then you still can't Fine. I didn't have anything Tell me
I got it.
else in that paragraph.
Yes, this next thing, 35.25.
a little bit about how you guys are handling 35.25 these days. Bring me up to date. To me, 35.25 is the full employment regulation for NRC inspectors into the next century, because 35.25 theoretically can be taken to extreme limits and, in fact, anything that is sort of off base in a radiation safety program could be interpreted as a violation of 35.25. you agree? MR. CAMPER: different than you. Well, I look at it a little Don't
I don't quite look it as the NRC full
employment thing, and the reason I don't is because the truth of the matter is I think that the degree to which we are scrutinizing supervision today is fairly lax. CHAIRMAN SIEGEL: Well, that's why I asked the
you what sets this up, and this is part of an even bigger issue that we've, you know, talked about a little bit, you and I, and we talked a little bit about within the ACMUI itself.
That's this whole question of what is the role of
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 the authorized user in 1995? The way Part 35 is structured
today, if you go back and look at the supervision issue over time, you'll find that there was a time when supervision had specifications associated with it, like being physically present or available within one hour or 15 minutes. Some
states, by the way, require that today, but in 1987 we relaxed, if you will, the term supervision. What the Statements of Consideration basically says is that we don't -- we remove the physical requirement, the availability requirement, within some defined period of time, because -- because of the various medical practice statutes within the various states and so forth and so on, and differences in institutions and what goes on in institutions, that the physician is in the best position to determine the degree of supervision that is warranted in their setting. Now from a regulator's standpoint, from our standpoint, that really causes a significant problem for our inspectors, because what it translates into is that our inspectors really don't become overly concerned about supervision issues from authorized user's standpoint until you get into situations like places where the doc flies in once a week, but in the meantime while he's not there, injections are occurring. Scanning is going on. Sometimes that raises problems as to whether or not adequate supervision is taking place, but as you know, --
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 I mean supervision, you can put in place a mechanism, a system for instruction and monitoring. do it yourself. You don't necessarily have to
You as a physician can make sure that your
chief technologist is properly supervising and monitoring and instructing, and then you're monitoring how that's going on. So it's very wide open today, and one of the things I'd like to see us do when we revise Part 35 is take a close look at what should supervision be today. role of the authorized user today? I would argue that the authorized user in 1995 is not the same thing as it was in 1965 or 1975. You know, back What's the
in those days, and you know very well yourself, the AUs were in there working with the technologists closely, hand in hand. You were developing radiopharmaceuticals, new procedures. You know, has the modality matured today to a point where physicians who just want to use materials in the course of the practice of medicine -- are these AUs like we had classically known them; and if they are or they are not, what's the appropriate level of supervision? So supervision is not something that gets dinged too often in violation space. Probably the most striking
example is where -- when the QM rule came along and people weren't instructed in the quality management rule, and that became a violation associated with 35.25(a)(1), failure to instruct in QM rule.
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 MR. LYNCH: MR. CAMPER: Or extreme situations. Or extreme situations where it
becomes clear to us that supervision is not occurring. Technologists have not been instructed. Then you get into
supervision violations, but they're usually pretty striking cases, actually. CHAIRMAN SIEGEL: Is there an appendix in 10.8
that gives examples of 35.25((a)(3), that periodically review the supervised individual's use of byproduct material and the records kept to reflect this use? I've always been troubled
by not quite knowing exactly what the right paper trail is for that paragraph. MR. CAMPER: No, there's not such an appendix.
You know, there's appendices in there to describe the various records that need to be kept. You get examples of the kinds
of records you should be keeping. MR. LYNCH: often it should occur. MR. LYNCH: Training. The training is in there. Training. Training is described, how
CHAIRMAN SIEGEL: MR. CAMPER:
Let me tell you, the best
description, I think, that you would find would not be in Reg. Guide 10.8. It would be in the recent Reg. Guide on
management of radiation safety programs in medical facilities. We talk a lot in there about reviewing supervised
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 individuals, reviewing the records and that type thing. MS. TAYLOR: MR. CAMPER: appendix in 10.8. No. Okay. The NUREG? The NUREG, NUREG 1560, but not as an
CHAIRMAN SIEGEL: MR. WAGNER:
The biggest problem with a lot of
these guidelines is the fact that, although these are guidelines about what the person should submit, they aren't guidelines as to what would be adequate. The reason is
because you're going to run into such variabilities that you don't really know what's adequate until you see what they're doing and then try to assess whether or not what they're doing is adequate for the situation they have. MR. CAMPER: That's a good point, and also even
before that, if you take a performance mentality approach -You know, you really want to have some fairly general concepts and guidelines about supervision, because in theory the user or the radiation safety officer is in the best position to reach that level of performance for their institution. So you don't want to intrude too much. MR. WAGNER: That's right. Then this next page gets us to How
CHAIRMAN SIEGEL:
the point where I think you may be intruding too much. did you decide that -MR. WAGNER:
When you indicate the next page,
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 here? CHAIRMAN SIEGEL: once every 30 days. MR. CAMPER: Let me make a comment on page 11 When you get into a The authorized user at least what page? CHAIRMAN SIEGEL: MR. CAMPER: Twelve.
Let me -- Can I insert a thought
before you do that, if I may, Barry.
discussion of Item 8, "Individuals Responsible for the Radiation Safety Program," we then move into a discussion of supervision. There is a lot more about the individual responsible for a radiation safety program than only the supervision. There's probably a lot more things that we
should be saying about it. MS. TAYLOR: The intent was you only bring in
specific things into these modules that are specific to this type of modality. of 10.8. The rest of it's covered in the main body
So that is in 10.8, and then they are directed --
That would apply to all uses of byproduct material in the medical users, and then we are supposed to address specific things in this guideline, instead of reiterating everything that's in the body of 10.8 into this -- each module. So the purpose of this module is just specific to mobile medical. There is a lot more, but they are told up
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 front at the very beginning. other things that apply. MR. CAMPER: MS. TAYLOR: Yes, you're right. And you should refer to that and There's a paragraph. There are
address those issues also. MR. CAMPER: MS. TAYLOR: MR. CAMPER: MS. TAYLOR: MR. WAGNER: MS. TAYLOR: MR. WAGNER: items identified. MR. CAMPER: Well, the only thing I would say, Where are we telling them that? At the very beginning. What do we say? On page 1. Yes. If you look at the first paragraph. In addition to the more general
though, is it might be worth a sentence or two in here, specifically drawing their attention to those key items. I
mean, the responsibility for the radiation safety program is a big deal, obviously, and it might not be a bad idea to ponder putting in just a sentence or two in there that would draw their attention to specific parts that they need to consider with regard -MS. TAYLOR: Then I think we need to do that for
all the other items, too, then; because all of these items do not go into all the information needed for each of those specific -- There's a lot more under radioactive material and
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 purpose. There's a lot more -CHAIRMAN SIEGEL: Well, except the only argument
in favor of what Larry is saying or an argument in favor of what Larry is saying is that, because of the physically distributed locations of use in a mobile service, the individual responsible for the radiation safety program has to be able to get around. So if you are going to institutions that have their own licenses, then it's the local radiation safety officers who are going to take the responsibility. If you're
going to places that don't have licenses, there has to be a mobile medical service radiation safety officer equivalent who takes over all responsibility, and we need to know something about what it is that individual does to evaluate safe radiation practices, both through supervision and through other things, the necessary environmental monitoring and things of that nature at each site of use. So I think the mobile service does point out a need for that. MS. TAYLOR: looking for? MR. WAGNER: It seems to me like what you want to You want to bring to their So what kind of sentence are you
point out what's specific.
attention that in addressing the more generalized items of regulatory guide 10.8 that the applicant must keep in mind
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 there? MR. WAGNER: MS. TAYLOR: -- situation. No. Does anybody have it? those issues that are particular to this mobile program in addressing those radiation safety needs. MR. CAMPER: MR. WAGNER: MR. CAMPER: MR. WAGNER: For example. For example. Very articulate. So it's just a matter that you're
just calling the attention to it, calling their attention to the fact that they have to specifically design their responses to 10.8 around their mobile -CHAIRMAN SIEGEL: Do you have regular old 10.8
CHAIRMAN SIEGEL: MR. CAMPER: we're back on page 1.
Just one more quick thing, since I want to mention as an editorial So
comment, we're referring to Reg. Guide 10.8 revision 3. this will be the next revision? MS. TAYLOR:
We're working with revision 2, and
this revision will be revision 3 Reg. Guide 10.8. MR. CAMPER: existing Reg. Guide. MS. TAYLOR: it will be revision 3. MR. CAMPER: Right. That's what I'm saying. But they're modifying that, too, and These modules will go into the
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 Currently, it's revision 2 is what exists. CHAIRMAN SIEGEL: Okay. Right? Okay.
Next page.
How do you
get to this every 30 day thing? MS. TAYLOR: History, I guess. But where? What's the I mean, if
CHAIRMAN SIEGEL: regulatory basis for that? someone is doing -MS. TAYLOR:
Help me out here.
I think that was probably policy
when this thing was first issued. MR. WAGNER: Thirty days rolls around real quick.
In some small situations, 30 days rolls around real quick. CHAIRMAN SIEGEL: I mean, I can think of
circumstances of very limited use where once a year is probably too frequent. MR. WAGNER: And other circumstances where once a
week is not frequent enough. MS. TAYLOR: We're asking them to indicate a
frequency, and we can evaluate that on the scope of the program at the time. MR. WAGNER: I think what you should do is you
should tell them that the frequency of the supervision must be consistent with the volume and type of practice, and that's what it should be, and that they should have the rationale for saying what the time interval should be; but they should specify a time interval for themselves.
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 advocate. suggestion. MS. TAYLOR: MR. LYNCH: I like that. And I think we're trying to provide MR. CAMPER: Yes. I think that's a good
license reviewers with a little better -- what would be -MR. WAGNER: I think that's very fine, because
now it will have to be spelled out by the user what he's going to do. So he has to meet what he says he's going to do, and
it has to be approved. CHAIRMAN SIEGEL: If you imagine a van that's
traveling around and they're doing bone scans, liver scans, and gated blood pool studies in the van, and that's all they do, what are you going to look at every 30 days to find out whether they're doing it right? MR. LYNCH: MR. CAMPER: It's the same old stuff. Well, let me be the devil's I
Barry, let me be the devil's advocate for you.
understand what you're saying when you say it's only nuclear medicine, so forth and so on, but imagine a scenario, if you will, where the van is going out and about. and a technologist on board. The technologist will decide to do things like soup up the doses, get the scans done quicker, which has happened even in institutional settings, would decide that, as has happened even in institutional settings, look, all these You have a driver
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 records every day, these daily surveys and so forth and so on -- this is nonsense. This is small mass material. These are
low exposure levels, and I'm just not going to do it, and I'll come back in later on and kind of fill it in. These things happen, unfortunately. CHAIRMAN SIEGEL: Now --
But I don't think that mobile
is any different with respect to that. MR. CAMPER: Well, it's only different in the
sense that the technologist is yet one more step removed physically from the presence of the authorized user. in a -CHAIRMAN SIEGEL: Unless the authorized user is a I mean,
radiologist right there in the hospital who is reading those scans as they are coming off the machine. MR. CAMPER: Or unless that radiologist is also
walking through the van looking at the books from time to time. I mean, the point is that in a fixed setting, the It's
users, as you know, are moving about in the department.
much easier to look over and see what kinds of doses are being assayed. Does the dose log look like it's right, and so
forth, look at the count rate on the camera, where is it. If all that is occurring out somewhere in a van, the user is not in the van. It's just the potential for that
to happen is greater, but again that doesn't necessarily imply that it has to be every 30 days. I'm just saying, it's that
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 kind of possible scenario that makes us wonder whether or not some defined period of time is not appropriate. CHAIRMAN SIEGEL: I got the picture. All right.
I didn't have anything else bothering me on page 12. MR. WAGNER: Can I get back to that then? I Is
mean, if that's the case, here you specified 30 days.
there any guidance that can be given to the user to say should be reviewed over intervals not to exceed such and such, but variable according to the needs; and you wouldn't want to say 30 days, but I would disagree that once a year was enough. CHAIRMAN SIEGEL: enough either. MR. WAGNER: MS. TAYLOR: But I think six months might be. Then we have no regulatory basis. I Oh, I didn't say that was
mean, that was one of the comments that came out, was the 30 days. We have no regulatory basis for a frequency -MR. CAMPER: MS. TAYLOR: from the past. MR. WAGNER: But you can make a recommendation in Yes, this is a "should." This was policy from previous TAR
a guideline that -- to tell people that, if they're only going to say they are going to supervise it once a year, you're not going to consider that adequate. You know, you can give an
upper limit, and I think my recommendation would be not to exceed six months, but must be -- but may be required to be
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 less, depending on the use and what you're doing, the scope of what you're doing, but it gives them some guidance. I mean, these are people who are going to be writing these things, and Lord knows what they're -MR. LYNCH: One of the things that we wanted to
do right in the Reg. Guide is write the Reg. Guide with as much information as we can put in, to make the licensee very clear on what we expect and what we will accept. MR. WAGNER: Right. I think, if you just say
something, that it shouldn't exceed six months, but it may be required to be less, depending on the scope and use of the material, and that the user should make a specification as to the intervals he feels most appropriate. MR. LYNCH: MR. WAGNER: Is six months too long? I don't know. That's very had to
say, depending on what -- I can see where six months probably is adequate. MS. TAYLOR: If we say six months, everyone is
going to come in and say six months, and then we can't argue with it, if the program seems very huge and it seems like they should be looked at every quarter. MR. WAGNER: Well, you could give an example.
You could give examples where in this situation an interval of six months might be required, but in another situation an interval of 30 days may be required.
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 examples. Right? You might be able to do that when you give your You're going to be making up examples for this.
Isn't that one of the things that we're going to be
doing later on, giving examples? So in the license examples you could say that, what the NRC would approve in this situation, this is a reasonable time; in another situation, it's not. You might
not have to write it here, but somewhere you got to have some guidance as to what kind of times you're going to require and not require. I think some examples would be worthwhile. It's
got to be variables, and their judgment isn't going to be the same as your judgment. CHAIRMAN SIEGEL: The other question -- Actually,
while we're on this, it says the authorized user should review the supervised use. That's actually not what 35 says.
Thirty-five says, "The licensee shall..." MR. CAMPER: Well, I was just pondering the same
thing, because what if you have a situation where you have a commercial entity and your AU functions as a contract employee of the commercial mobile lab for purposes of image interpretation? Now the licensee is the mobile entity. CHAIRMAN SIEGEL: There has to be a prescribing There has to
physician somewhere in the loop, does there not? be someone who wrote the procedure manual.
There has to be an
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 licensee. CHAIRMAN SIEGEL: It wouldn't be a pathologist implicit prescription to give the drug for the practice of medicine in the state. MS. TAYLOR: But that could be at the client
hospital where they are just coming in and -CHAIRMAN SIEGEL: it's the licensee. That's correct. I really think
Let's say that the way you've got --
You've got a mobile medical service that doesn't have any physicians in its employ, but has a terrific health physicist who runs the program. MR. CAMPER: Right. Exactly.
CHAIRMAN SIEGEL:
And that's actually the
preferred person to be reviewing the use, rather than the radiologist, who couldn't care less. look at the pictures. MR. CAMPER: MS. TAYLOR: Right. So throughout Item 8, change that to All he wants to do is
who became a nuclear medicine physician -- a radiologist. Okay. MR. WAGNER: So it's going to say that the
licensee should review the supervised individuals' use of byproduct material on a periodic basis, depending upon the scope and use of -CHAIRMAN SIEGEL: Well, does a mobile service
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 have a radiation safety officer? MR. CAMPER: designated, yes. CHAIRMAN SIEGEL: So then, really, up above A radiation safety officer is
shouldn't we indicate the frequency with which the RSO or AU? MR. CAMPER: Well, licensee is a better term,
because the licensee can be the users. CHAIRMAN SIEGEL: previous sentence. But that doesn't work for the
"Indicate the frequency with which the
licensee is physically present..." MR. CAMPER: MS. TAYLOR: this whole thing. Or the licensee's representative. Well, we're going to be changing
That will fix itself out. The licensee's representative is
MR. CAMPER: physically present.
CHAIRMAN SIEGEL: MR. WAGNER
Okay, got it.
Then the theory is that it will be
consistent with the scope of use radioactive material, and then maybe within the examples that you give somewhere, they can go back and see the examples for examples of periodicity. CHAIRMAN SIEGEL: Remind me never to open -MR. WAGNER Yes, these things -- well, they have Boy, is this complicated.
some very sticky, very sticky kinds of issues that you an get involved in with crossing state lines as one of them we
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 Okay. high winds. MS. TAYLOR: Right. Okay. page 12? what? MS. TAYLOR: Apparently, someone in -Given the fact that we know haven't even addressed yet. CHAIRMAN SIEGEL: Right. Okay. Anything else on
Protected from the elements, up to and including
CHAIRMAN SIEGEL:
that tornadoes are attracted to mobile units of all sorts, it's a well known fact. So how do we think that a mobile
nuclear medicine van can be protected from a tornado? MS. TAYLOR: Magic. Well, this came about from
talking to someone in Region 2, who apparently had experience with a licensee that had a garage that was pretty rundown, and it really wasn't very secure and what have you. can't protect them from a tornado. CHAIRMAN SIEGEL: Doesn't say tornado. It says So -- You
CHAIRMAN SIEGEL: That's fine. Page 13.
Tornado is a form of high wind. On the third line of 10.2.1 and
10.3, "...and check all other transported equipment for proper function before medical use at each address of use..." Although that's good practice, it's not Part 35. Part 35 It's
doesn't require me to make sure my camera is working. good medicine. MR. WAGNER: What do they mean, "all other
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 35(a). CHAIRMAN SIEGEL: MR. LYNCH: What? transported equipment"? flushes? CHAIRMAN SIEGEL: MR. CAMPER: Camera works, toilet flushes. Do they want to make sure the toilet
The cameras, dose calibrators. No. Dose calibrators are
CHAIRMAN SIEGEL: specifically required.
"All other transported..." -- Although
I agree with you, you've gone a bridge too far in terms of what -- because the problem is -- and here's the problem. If
I put that in a license, even though you don't have the right to force me to put it in a license, it just became a license condition. MR. LYNCH: Well, see, that's what it says in
35.80(b) says, "Check survey
instruments and dose calibrators, as described in 35.50 and 35.51, and check all other transported equipment for proper function before medical use at each address of use." MR. WAGNER: transported equipment"? CHAIRMAN SIEGEL: MR. CAMPER: So you did that to -The What does that mean, "all other
We have a regulatory basis.
question is, why do we have the regulatory basis? CHAIRMAN SIEGEL: nobody caught it. Because you snuck it in, and
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 MR. WAGNER: It would be --These are the kinds of
problems, though, that gets the users angry a lot of times, because it's so generalized. CHAIRMAN SIEGEL: to be checked. MR. LYNCH: Well, it says for medical use. So Right, but again the camera has
that rules out your toilet scenario. CHAIRMAN SIEGEL: And you don't have to check the
spark plugs and carburetor in the van. MR. CAMPER: That's an interesting point. I
mean, that would seem to get at the gamma camera. CHAIRMAN SIEGEL: MR. CAMPER: It sure does.
But you know that we don't require
quality assurance, for example, on a gamma camera. CHAIRMAN SIEGEL: Well, from a practical, medical
point of view, it's logical that if you're moving gamma cameras around, you want to check them before you use them, because road bumps are more likely to do that, and that may have been the way you snuck it in here. MR. CAMPER: I think the logic was exactly that.
I think that there was assumed a higher probability of failure of imaging cameras and so forth because of the transporting. Therefore, this -CHAIRMAN SIEGEL: But it would be interesting to
know how you have evaluated whether those checks that have
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 not. important. been written in licenses in the past are adequate. MR. LYNCH: We would just ignore, basically,
gamma camera checks, even if a licensee -CHAIRMAN SIEGEL: Even though you have the
regulatory authority to do it that you didn't know about until I opened my big mouth. MR. CAMPER: for the record. CHAIRMAN SIEGEL: MR. LYNCH: away from it. MR. CAMPER: That's right. Well, though, it actually is That's fine. Let's adjust that TI. Just kidding,
I think we have historically stayed
CHAIRMAN SIEGEL:
It's just good medicine to not give a dose of
something until you're sure that the camera is going to be able to take a picture. MR. CAMPER: MS. TAYLOR: realize that. MR. LYNCH: MR. CAMPER: The states. That's a good point. Now the We don't get into that. That's interesting. I didn't
states, in many cases, do have specific requirements. MR. LYNCH: MR. CAMPER: Right. In most cases, I would say.
And they do inspect them, but we do
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 CHAIRMAN SIEGEL: This is a clear example of
Parkinson's Law, but we're keeping busy here. MS. TAYLOR: As a comment, I notice in 11.9 and there's one beforehand, some of these things we've talked about needing an exemption, I haven't actually quoted the regulation in the exemption. So we'll put a generic, "this
will require an exemption from such and such, and you should submit it for whatever." the van. CHAIRMAN SIEGEL: MR. WAGNER: Okay. This particular one is delivery to
It's interesting that it does say
all other transported equipment, but your second sentence there says, "Describe your procedures for taking survey instruments and the dose calibrator." want. MS. TAYLOR: Yes, but we were just quoting 8ED, That, you specifically
and then we want to get into the stuff on the survey meter and the dose calibrator. MR. CAMPER: Yes, we're clearly focusing on the with distinction to 35.50-
first part of 8ED which draws you .51. CHAIRMAN SIEGEL:
Interesting.
Okay.
Page 14.
I guess you're stuck with therapy not being permitted because of current Part 35. MR. CAMPER: That's right.
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 CHAIRMAN SIEGEL: But you would grant an
exemption for therapy if confinement was not required. MS. TAYLOR: Right. Is that correct? Well, we would consider
CHAIRMAN SIEGEL: MR. CAMPER: such an application.
Correct.
We have not granted one yet. Because it's interesting that
CHAIRMAN SIEGEL:
you would allow -- This allows someone to be given 10 millicuries of I-131 for whole body imaging of thyroid carcinoma for imaging in a van, but doesn't allow someone to get 10 millicuries of I-131 for treatment of hyperthyroidism, which is a little bit silly, if you think about it; because the radiation safety considerations are identical. MR. CAMPER: Yes. Currently, if you go back to
35.29(a), Barry, it says that the Commission will license mobile nuclear medicine service only in accordance with subparts (d), (e) and (h). So that gives you (d), which is
35.100, (e) which is 35.200, and then (h) which is your -CHAIRMAN SIEGEL: densitometry. It's probably bone
Is that what that is? Yes. Which is no longer an issue, Yes, that -- I mean, that's right?
MR. CAMPER:
CHAIRMAN SIEGEL:
since everybody is using X-rays.
something for a fix in Part 35 next time around. MR. LYNCH:
And we're trying to say that we would
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 here. out. allow it, but should we go further than we've gone here? CHAIRMAN SIEGEL: encourage applications. Well, I wouldn't necessarily
I think there many reasons why
getting treated by a mobile service is not the optimal medical arrangement in that the follow-up arrangements are not likely to be real terrific. MR. WAGNER: Screening for pregnancy. Yes. There's a lot of good
CHAIRMAN SIEGEL:
reasons why it's not the best way to do it, but I think it should be allowed, but -MR. CAMPER: I have a question. I'm reading
I'm wondering something.
Torre, maybe you can help me
(d), (e) and (h) -- (d) is uptake dilution and (e) is unsealed byproducts materials for imaging (f) is radiopharmaceuticals for therapy. Correct.
excretion.
and localization.
CHAIRMAN SIEGEL: MR. CAMPER:
(f) is not cited under 35.29(a). Correct. It's excluded.
CHAIRMAN SIEGEL: MS. TAYLOR: MR. CAMPER:
That's why they need an exemption. I understand. So are we clear that
that requires an exemption? CHAIRMAN SIEGEL: Yes. Oh, yes. In fact, the
first line on page 14 in that paragraph. MR. CAMPER: So the idea is that, as we would Good.
give it to them, it would clearly require an exemption.
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 week. Good. MR. LYNCH: But we wanted to point it out as, you We don't necessarily encourage it,
know, it is an exemption. but we'll consider it. MR. CAMPER:
And the rationale is that it's --
Even though it's therapy, it's a releasable -- patient releasable amount. So we've chosen to draw the distinction to
that particular category there, as opposed to not considering the other more complicated modalities at this point in time. MR. LYNCH: Somebody could come with an exemption
request saying, I want to do CA therapy, 100 millicuries -CHAIRMAN SIEGEL: Which is when you're looking to
drive them around in a truck for a week until -MR. CAMPER: Now at some point, we're going to
have to come back with guidance, if we ever do move toward licensing, say, a mobile HDR. create a separate guidance. the state of California. CHAIRMAN SIEGEL: Page 15, the second paragraph. We'll have to come back and Mobile HDR has been licensed by
When 35.75 becomes revised, you'll need to update that language. MR. CAMPER: MS. TAYLOR: MR. CAMPER: It will be -That's right. I had the same note.
When will that become final? Well, it has gone to the EDO this
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 out? MR. CAMPER: MR. WAGNER Yes, it could. What is it going to say? Well, unless John has pulled a MS. TAYLOR: So it will be final before this goes
CHAIRMAN SIEGEL:
fast one on me in the last 10 days, it's going to say that exposure has to be less than 500. MR. CAMPER: Right. And that you have to instruct That's a simple version of what
CHAIRMAN SIEGEL: people if it's more than 100. it says. MR. CAMPER: MR. WAGNER
With some particular instruction. And nothing about quantities? Well, no -- Yes and no.
CHAIRMAN SIEGEL:
There's the 500 milligrams as the simple regulation, and then there's the no-brainer regulatory guide approach that says, if you're below this number, you an be assumed to be in compliance. MR. CAMPER: But the language in the rule itself Dose driven. It's actually a little more
does not say 30 millicuries. CHAIRMAN SIEGEL:
than 30 millicuries, the way it recalculates that, 36 millicuries. Okay. Back to 29.9. Yes, that will give you 36.5.
MR. LYNCH:
CHAIRMAN SIEGEL:
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 No, actually, those will be less of a problem now, because by calculation there's going to be 80 millicurie administrations in people -MR. CAMPER: a note in the margin. Let me ask a question here. I have
Bottom of page 14 says, "If you wish to
perform radioactive drug therapy procedures, you must request an exemption from this regulation and provide a detailed explanation as to why an exemption is needed. will be reviewed on a case by case basis." What about I just want to do it for this purpose. I want to provide that service. Is that a reasonable Such requests
explanation for granting an exemption to do up to 30 millicuries of iodine therapy? MR. LYNCH: Because I'm going to provide a
service to someone and make it more convenient for them, provide them the service? MR. CAMPER: What I'm saying is we've seen --
Obviously, we now know we're treating this category of therapy -CHAIRMAN SIEGEL: I don't think that's a problem.
I understand what you're saying, but since it requires an exemption, can you imagine asking for an exemption and not saying why you want the exemption? MR. CAMPER: I understand. What I'm saying is
that, let's say I come in and I say in my application I want
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 say that. to provide the service of up to 30 millicuries of iodine therapy as a service. MR. LYNCH: MR. CAMPER: To make more money. No, I want to -- Well, you wouldn't service
You would say, I want to make this
available to my clients. exemption?
Is that an acceptable reason for the
One gets the impression from reading this that, you know, if you're going to seek an exemption, there has to be a pretty good reason for doing it because of therapy procedures, and is the availability of the service, in and itself, an adequate reason? throwing out the question. CHAIRMAN SIEGEL: Given that mobile nuclear I'm not saying it's not. I'm of
medicine services generally provide services to the kind of less sophisticated clients that you've been discussing, I think that's a reasonable answer to the question. On the other hand, if someone says they want to do mobile nuclear medicine and want to provide it at hospitals in the city of St. Louis, then -- I mean, I can't imagine why anybody would want to compete with Washington University and St. Louis University to provide that service in the city, because of all the hassle that goes with providing that service, the quality management program, the other rigmarole. So I think -- I mean, just say my clients need
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 yes. MR. WAGNER: Item 2 on page 16, last sentence. 16? CHAIRMAN SIEGEL: We are trying to get there, this service; I want to provide the service. acceptable reason. MS. TAYLOR: And I'm sure the reason would be That will be an
it's rural areas, and they don't have access. CHAIRMAN SIEGEL: I assume that the service in I
St. Louis is not currently pursuing therapy, are they? don't care.
I mean, seems like everybody else in town has
stopped doing therapy, and I'm so tired of seeing every hyperthyroid patient in St. Louis, I could scream. MR. WAGNER: Regulatory guide -- Are we on page
"If you determine that bioassays are not required, provide justification for this conclusion." Are there any other
guidelines the NRC can give people to give them guidelines as to what justification will be required, what circumstances they accept as being justification not to have to do a bioassay, anything more specific somewhere? MR. LYNCH: MR. WAGNER: refer them to? MR. CAMPER: think for a minute. I understand your question. Let me The Reg. Guides. Are there Reg. guides that you can
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 MS. TAYLOR: It isn't only Reg. Guides per se.
There's been a couple of TARs we've been working on. MR. WAGNER: Well, there might be some guides in There
some other modules, because this only refers to mobile.
might be guides in some other modules saying, if one is making out their license, what would constitute a requirement -MR. CAMPER: MS. TAYLOR: An adequate justification. Well, Sally's guide is pretty much
going to require it, because patients covered under her guide are probably going to have to be hospitalized, and bioassays are required under 3.15(a)(8). MR. WAGNER: lies the rub here. See, I mean, if you're -- therein
I mean, clearly, if you're going to have
patients who are going to require hospitalization, okay, bioassay is probably going to be required. about all diagnostic here. MR. CAMPER: Yes. When you're above 30, it gets We're talking
a little simpler, except when you doing capsules, there's some interesting discussions going on today. MR. WAGNER: Of course, but I'm trying to get you
to think about whether your guidelines -- what will you accept, and what does a person really have to say here? CHAIRMAN SIEGEL: But that's based on the
probability of exceeding X percent of the annual limited intake.
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 MR. WAGNER: Correct. Isn't that what the Part 20
CHAIRMAN SIEGEL: guidance is based on here? MR. CAMPER: Yes.
That's correct. Okay. So the way you do that,
CHAIRMAN SIEGEL:
and this is a health physicist calculation -- this is not something you pull out of a table. As you look at -- or maybe
it is, and I just don't know those Reg. Guides, but you look at the total amount of I-131 used and the number of people who are going to be using it, and over what period of time, and -MR. WAGNER: though, here. CHAIRMAN SIEGEL: But that is literally the Right. That's my whole point,
calculation that is required as part of any license application. MR. WAGNER: I don't disagree with that. My only Here,
point here is to tell the person what he's got to do. it's very general.
It says, "If you determine that bioassays
are not required, provide justification..." CHAIRMAN SIEGEL: Well, don't you think Reg.
Guide 8.20 tells you how to go about it? MR. CAMPER: It does. It talks about activity
levels, the form in which it exists, and it may be that -CHAIRMAN SIEGEL: MR. CAMPER: And 8.9 is even more detailed.
Right, and you're not exceeding
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 in there. those thresholds in terms of quantities or form, as described in those guides, then you can explain that you're not doing that. MR. WAGNER: But you can tell the person. I
mean, if you determine that bioassays are not required -- All I'm asking you to do is give the person who is going through this thing, saying, how do I determine that, and go back to here. Well, just be more specific in the statement. MR. CAMPER: is acceptable. MR. WAGNER: Yes. If you determine that Okay. So clarification as to what
bioassays are not required, as determined by whatever is in those regulatory guides, provide the information. saying provide justification. You're
It's like you're trying to
provide something over and above what they've already done. MS. TAYLOR: I'm not really sure what we can put
There's so many variables as to why they could I mean, we could just say,
determine it's not necessary.
please describe how you reached this conclusion, and make it sound a little less harsh. MR. WAGNER: MR. CAMPER: Yes. Yes, you could do that. You know, how
You could do that.
you reached this conclusion; for example, a discussion of the evaluation. MR. WAGNER: Right.
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 days? too. procedures. hours." punitive. MR. WAGNER: There you go. There you go. me -MR. CAMPER: MR. WAGNER: It's harsh. And I would sit there and struggle MR. CAMPER: MR. WAGNER: Yes, something like that. The way it's written, it just tells
with that, I've got to justify this now after I've gone through all this. Just asking to clarify that. It can be made a little less
MR. CAMPER:
CHAIRMAN SIEGEL:
Okay, next up, emergency
This is another one of these "should equals three
how did you get to that number? MS. TAYLOR: I'm sure OGC had a comment on that,
We didn't get to incorporate all the OGC comments,
because we didn't get them, and she was commenting on the basis for these numbers. MR. LYNCH: MS. TAYLOR: MR. LYNCH; MS. TAYLOR: They didn't comment on that. They didn't? No. They did on the 30 days. What did they say about the 30
CHAIRMAN SIEGEL:
They just said how did you get that number? MS. TAYLOR: What's the regulatory basis. I mean, I can -- it's hard for
CHAIRMAN SIEGEL:
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 me to understand if unit doses of technician are all that are being used by a mobile service, why are a response time under three days is necessary. MR. LYNCH: What can happen? of
Adverse reaction? That's a medical issue.
CHAIRMAN SIEGEL: MR. CAMPER: contaminants. MS. TAYLOR:
People walking through it, spreading
Well, let's not put the time in. There again we get back to the
Let's just see what they say. reasons.
They're going to come back, well, give us what's Is one hour acceptable? MR. CAMPER: Well, I mean, if you just leave tech
acceptable.
lying about, syringes spilled. MR. LYNCH: If it's in the hallway and the
waiting room, that's not an acceptable situation. MR. CAMPER: That's right. So I'm saying, you
have the spread of contamination issue. MR. LYNCH: MR. WAGNER: At least, this limits -But the issue here is quite clear.
Why does it have to be the radiation safety officer or the authorized user that's got to show up on the scene? If it's
contamination in the area, the chief tech ought to be able to go down there and take care of that issue. Why does he have
to respond within three hours, because somebody did that? This happens frequently. They got to clean it up. They know
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 they got to clean it up. MR. CAMPER: designee, for one thing. MR. WAGNER: there you go. MR. CAMPER: That's right, because as a practical Or a responsible designee. Yes, Yes, it should be -- or their
matter you've got the one tech out there somewhere, and they had that instruction theory. CHAIRMAN SIEGEL: Well, that person obviously can
respond within three hours, because that person is there. MR. WAGNER: Right, and if they just tell you
that this person is trained to clean up -- this person as a tech is trained to clean up every kind of isotope we use and that we can't think of anything more serious than what we've got, this is how we're going to do it. MS. TAYLOR: Do we need to segregate out the
accidents and spills from the misadministrations and such, because I mean, you're right, an authorized user really is only going to show up in the event of a misadministration. MR. CAMPER: Well, you know how this is written.
What was in the mind when it was written was, it wasn't so much that the technologist wouldn't be there. We're not clear
about that, by the way, and we need to clarify that the designated responsible for that; but I think what's happened here is the idea that, even if that occurs, that the RSO is
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 going to play an active role in monitoring the situation. MR. WAGNER: MR. CAMPER: Right. And that such active role would
dictate that they would be there and see what's going on at least within three hours. Now that raises a question.
Couldn't the designated responsible individual go through the appropriate steps to decontaminate, contain the spill, etcetera and through telephone communication with the RSO be providing him with input, you know, like I've cleaned it up, I'm getting, you know, survey meter measurings now of thus and so. I've done wipe tests. They demonstrate thus and so.
I mean, does the RSO have to drive all the way across Montana to the van, when telephone communication with a trained, responsible individual could suffice. MR. WAGNER: But then if you give them an
exemption for therapy, now you've got a little bit different situation, and then they've got to address that issue, and that comes under quality management program anyway. think we have to take the three hours off. MR. CAMPER: Well, it has to be -- The response So I
has to be commensurate with the level of the problem. MR. WAGNER: Level of activity of the individual. If
They have to be prepared to respond to whatever they do.
they're dealing with just simple diagnostic tests and stuff, then the chief tech is there on site all the time, and he's
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 going to be trained to do these things. So we don't really
need to have anybody respond in three hours. CHAIRMAN SIEGEL: Well, I mean, couldn't you even Procedures should be
make it more generic than that?
submitted -- this first sentence now -- to indicate that the radiation safety officer and/or authorized user will be available to direct the response to incidents. MR. WAGNER: Yes. And that could be telephone.
CHAIRMAN SIEGEL:
That could be five minutes away and physically present, as opposed to -- You don't want a mobile service being run by a technologist when the only RSO is canoeing up in the Yukon and is not reachable. So there has to be a way to reach someone
responsible to figure out how to handle things. MR. CAMPER: But, you know, in this day and time,
they could even be reachable while canoeing in the Yukon. CHAIRMAN SIEGEL: MR. CAMPER: If they choose to be.
I mean, today pretty much, with
telecommunications, satellite link-ups, mobile FAXes, etcetera. MS. TAYLOR: I would worry about somebody who was
communicating by satellite. MR. LYNCH: Do we want to give examples here,
that three hours would be a reasonable or -CHAIRMAN SIEGEL: Yes, I kind of prefer the
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 story. CHAIRMAN SIEGEL: I would say, call the radiation I-131 -MR. WAGNER: Of course, you have a different example approach as opposed to the "should" approach. MR. WAGNER: MR. CAMPER: MR. WAGNER: MR. CAMPER: Right. The time frame as an example. As an example for a given situation. But, again, it has to be specific to
the situation, an iodine scenario. MR. WAGNER: MR. CAMPER: That's entirely different. So we'll do that, Barry. Right. We'll use
that timeline as an example, but point out that it must be specific to the event at hand, for example, iodine spill, much more close monitoring, and so forth. MR. WAGNER: It depends on what quantity of iodine, too, you're talking about here. Right. Quantities and isotopes.
MR. CAMPER:
CHAIRMAN SIEGEL: just thinking.
Yes, I mean, because I -- I'm
If we had a technician spill occur in the
middle of -- while a tech was doing something in the middle of the night and I got a phone call, I can tell you, I'm not going to go to the hospital. I would say, clean it up, tape
off the room, post a sign, and I'll see you in the morning. MR. LYNCH: But if you dropped 30 millicuries of
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 CFR. MS. TAYLOR: Is that from Bob Gettone? Right? really. here. MS. TAYLOR: MR. CAMPER: MS. TAYLOR: Yes. Where were we, transportation? Yes. Transportation. safety officer. It's too dangerous. Clean it up, contain it, and call me
MR. CAMPER: in the morning.
CHAIRMAN SIEGEL:
Take two aspirin.
Take two
potassium nitrates and call me in the morning, immediately. How about that? MR. CAMPER: And put all your swabs in a plastic
bag, and call me in the morning. CHAIRMAN SIEGEL: Okay. We're getting punch
CHAIRMAN SIEGEL: MR. CAMPER:
That's pretty straightforward,
The quarterly audit -- Is that a clear requirement in
49, Item b. CHAIRMAN SIEGEL: MR. CAMPER: Where?
B, Item b. What page are we on?
CHAIRMAN SIEGEL: MR. CAMPER: MS. TAYLOR: MR. LYNCH:
Seventeen. Do you know, Jim? I don't know. That's not from 49
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 Would it mean 71? It wouldn't mean 71, would it? No. As I read it, at least as written,
MR. LYNCH: MR. CAMPER:
one gets the impression that that quarterly audit requirement is contained within 49 CFR. MR. LYNCH: MR. CAMPER: MS. TAYLOR: MR. CAMPER: I don't believe it is. I'm not certain that it is. Well, I'll check it. Now we do say "should," but again it
would be interesting to know why we're settling on a quarterly. MR. WAGNER: in periodic? MR. CAMPER: arrived at quarterly. exactly. MR. WAGNER: MR. CAMPER: Right. All right. So 18? I'd like to know more about how we I'd like to know about what 49 says Is that another place where we put
CHAIRMAN SIEGEL:
This storage now -- Again, if
the client facility has got a license, does 35.80 preclude -MS. TAYLOR: Yes. You have to bring into each So you
address of use and remove it at the end of each day. have to bring it back into your control. MR. CAMPER: Yes, you have to remove it.
Currently, as written, you have to remove it.
Bring it in,
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 going on. and remove it. MR. WAGNER: Even if they have a license? What if the --
CHAIRMAN SIEGEL: MR. CAMPER:
Well, someone could -Let's say, a hospital has its
CHAIRMAN SIEGEL:
own nuclear medicine department, one camera, and they order stuff from Syncor. They have their own waste stream, but
because they've got unusually busy, they requested that a mobile service comes and provides them with an extra camera, and before they decide whether they're going to buy another one. So they've got parallel operations going on. literally, the stuff that was used by the mobile service cannot enter the waste stream of -MR. CAMPER: That's correct. Okay, that's fine. So,
CHAIRMAN SIEGEL: MR. CAMPER: MS. TAYLOR:
Now one could pursue an exemption. It's not just because of this. I
think it would be the wastes. CHAIRMAN SIEGEL: one licensee to the other? MS. TAYLOR: licensee facilities. MR. CAMPER: right. You have several things You can't have wastes at other Could doses be transported from
You have the restriction here, but you also have
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 broker. MR. CAMPER: if you do that. You're getting to be a waste broker, the consolidating and integrating of someone else's waste into your waste stream. You can't do that. You can't do that, because you have
MS. TAYLOR:
to be responsible for it to the end. CHAIRMAN SIEGEL: licensee A to licensee B? MR. CAMPER: they meet the criteria. according to Part 32. Oh, yes, sure. Sure, as long as Can doses be transferred from
They're either a manufacturer, They're prepared by an ANP or an AU or Yes.
someone under the supervision. MR. WAGNER:
That's the way to do it, just
transfer it into their storage facility and let it sit there for a few days. MS. TAYLOR: MR. WAGNER: authorized to have it. MR. LYNCH: MR. WAGNER: have that isotope. it? MR. CAMPER: MS. TAYLOR: Not waste. They're classified as a waste You can't with the waste. You can transfer it over if they're Sure. Not waste. Why can't -- They're authorized to
What does it matter whether you transfer
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 is a -MS. TAYLOR: MR. WAGNER: This is the result of a TAR. It's a really difficult issue, you. MR. WAGNER: It seems to me it would be a little your waste. MS. TAYLOR: from beginning to end. MR. CAMPER: That's right. You want to collect You're responsible for your material
If you want to accept waste, you need to be in
the waste business. MS. TAYLOR: There's a business out there for
bit expensive, but unfortunately, that's the way it is. This next issue on page 18 and 19 is an interesting issue, and I must admit, it's one that sort of really boggles my mind. CHAIRMAN SIEGEL: MR. WAGNER: Which one? I mean, this
The one with excreta.
because we run into this problem in a different fashion in the state of Texas. What's happened is we had a situation where It was an
one hospital injected a patient for a bone scan. elderly patient that was incontinent. The patient had a diaper. CHAIRMAN SIEGEL: interesting. Go ahead.
The patient was -That's
I had the same note.
MR. WAGNER:
The patient released -- was released
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 this. from the hospital, went to an outlying clinic. outlying clinic, the patient changed diapers. At the One of them
ended up in a trashcan, which was immediately picked up and taken to a dump site where it set off the radioactive monitors, which caused one heck of a stir and a lot of people's time and effort over this one issue, and then how to resolve it; but the state, unfortunately -- the inspectors were focused on the idea of how do we cite the individual rather than cleaning up the problem, taking care of the issue. It was the contention of the hospital that their responsibility for that radionuclide stopped after the injection of the patient, because that was the legal dissemination and disposal of the isotope, and it's documented on their forms that this is how I disposed of this patient, whatever, and it's done for. Now I was thinking about that. I was thinking, What
well, what if the patient didn't go to the other site?
if the patient went up to another room, was an inpatient and went to another room, and now you have excreta, and that situation? CHAIRMAN SIEGEL: Let me make sure I understand
If a patient is not required to be confined under the
conditions of 35.75, then you don't really need to do anything -MR. CAMPER: That's correct. You do not.
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 CHAIRMAN SIEGEL: -- to monitor that patient so
long as you maintain within the overall environment compliance with Part 20. Correct? That's correct. NCRP has
MR. CAMPER:
recommendations about diagnostic patients, you know. CHAIRMAN SIEGEL: Right, but diapers are an
interesting problem, because they don't end up in the sanitary service system. MR. CAMPER: But from a regulatory standpoint,
they're not confined under the least criterion of 35.75, you do not have to do anything about that. MS. TAYLOR: But also, excreta of the medical
patients is excluded from anything anyway. CHAIRMAN SIEGEL: sanitary sewage system. MR. CAMPER: sewage system. MR. WAGNER: And that's wherein, I think, lies Only if it's into the sanitary No. Excreta goes into the
the rub here on this guideline, in that you're trying to distinguish excreta going into the sanitary sewer line versus excreta going and being disposed in a toilet in a mobile van. MR. CAMPER: Well, the reason is -- Well, the
patient excreta is exempt, because it's in a dilution, infinite dilution, whereas in the case of the holding tanks, you do not have infinite dilution. You now have contained
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 at all? on there. radioactivity in a holding tank. MR. WAGNER Well, I think if that's the case, This
then that's what this guideline should be addressing.
guideline should be addressing that kind of dilution and that kind of problem, if that's what you're trying to get at. The safety issue, as I see it -- Anybody who has a toilet on a van with patients coming in, they're going to have a contamination problem all around that toilet, if they permit the patients to use that toilet. there, period. MR. LYNCH: departments. MR. WAGNER: Yes. I mean, it's definitely going As it is in most nuclear medicine It's going to be
to be there, and I can see where the concern is, but I have a hard time seeing that it's going to be -MR. CAMPER: Well, let's take a look at the first
We're saying, describing the structure of the How would you spin that
holding tank and so forth. differently? MR. WAGNER:
I have no idea.
I mean, I have a
lot of problem with the whole thing. MS. TAYLOR: Do you think they shouldn't allow it
We have a TAR in with that right now, and these are
the issues that we've come up with between two of our branches.
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 question. asked. MR. WAGNER: I think that's a reasonable allow it. MR. WAGNER: I don't think it's a problem to
The question is what kind of quantities are we What kind of quantities are they talking
talking about? about? problem.
I mean, this -- To me, this should represent a nonIt should be a non-hazard, because (a) what are you
usually concerned about? First of all, let's look at internal contamination. It doesn't represent a risk for internal What it does maybe represent a risk is
contamination, period.
risk from gamma radiation that might emanate from it, but what kind of activities are we going to require for gamma radiation in a holding tank of this facility? underneath the driver's seat? MS. TAYLOR: Well, these are the questions we've Is the holding tank
Maybe it's underneath the driver's seat or
something, just to make sure. MR. CAMPER: Well, we do. We say, you know, we
ask, tell us about the structure of the holding tank. MR. WAGNER: MR. CAMPER: Right. Right. Right.
Where is it in regard to the public,
workers on the van, driver of the van? MR. WAGNER: But are they really responsible for
the -- legally responsible for the activity after it's been
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 correct. explicit. collected. MR. CAMPER: In this case, they are, yes, because It is not being released into the injected into the patient? MR. LYNCH: Oh, yes. I mean, if the excreta is
excreta is being collected. -MR. WAGNER:
Where in the regulations would it Where in the
say that they would be responsible for that? regulations? MR. CAMPER:
Well, I would -- The regulations are The regulations are explicit
It's the other way.
that excreta is exempt -MR. WAGNER: MR. CAMPER: sewage system. MR. WAGNER: But that doesn't mean -- Yes, that's That's correct. -- if it's going into the sanitary
That, I understand. MR. CAMPER: Well, if I'm not putting excreta
into the sanitary sewage system, then I still have responsibility for it. MR. WAGNER: It's not exempt. But they've already injected it into
the patient and disposed of it in the patient. CHAIRMAN SIEGEL: same thing as if -MR. CAMPER: Well, let's take another example. I know, but I mean, it's the
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 not exempt. CHAIRMAN SIEGEL: So the correct way to handle Let's take another example. to collect stool. Okay? Let's take the old studies we use
We were responsible for it. But you can flush it down the
CHAIRMAN SIEGEL:
toilet when the study was over. MR. CAMPER: Sure. I'm simply saying, though,
there was an example where that same stool introduced directly into the sanitary sewage system would have been exempt, but it was not. In that case, we were holding it for purposes of In this case, we're holding it for
conducting a study.
purposes of convenience to the patient, because patients have to go to the bathroom, but we have the need to hold it until we can release it into a sanitary sewage system. During that holding manipulative process, it's
this is to set up a little outhouse a block away from the van. MR. WAGNER: just a little park. MR. CAMPER: All you need is a long tube, a long You don't even need an outhouse,
tube into the nearest toilet. MR. WAGNER: I mean, presumably the excreta from
the patient is out of your responsibility, once the patient leaves the van, but it's not out of your responsibility while the patient is in the van. MR. CAMPER: Correct?
Right.
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 CHAIRMAN SIEGEL: MR. WAGNER: Say that again, slowly.
Your responsibilities leave with the You're not responsible for the
patient leaving your van.
patient's excreta once he leaves your van. MR. CAMPER: MR. WAGNER: That's correct. And you are responsible for the I
patient's excreta as long as they are inside your van.
don't know where it says that in the regulations, but -- or where you would find that, if there was interpretation of the regulations. That's fine. I mean, it's not --
Actually, I agree with it.
As a radiation safety issue, it's quite clear. CHAIRMAN SIEGEL: MR. WAGNER: It really is clear.
It's quite clear. Why don't we break for lunch,
CHAIRMAN SIEGEL:
since we've been having this lovely conversation. MR. CAMPER: thought, real quick. I do have one more. One more don't
That is somewhere in here, and I
know just where it should be, but I would like to include a paragraph or two that talks about these reciprocity issues. Someone while ago mentioned this idea of crossing state lines. What we need to do is draw to their attention that reciprocity does exist and that they will need to check specifically with the state in which they wish to go to provide services for what is necessary in that state, whether
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 it's a license or whether or not there's some reciprocity arrangement. Most of the states have a reciprocity arrangement with a following need to get a license. CHAIRMAN SIEGEL: MR. CAMPER: requirement is variable. of that. MR. LYNCH: MR. CAMPER: That's a good point. The fact that you get an NRC license Yes.
And the time frame for that license So they're going to need to be aware
doesn't mean you can go into North Carolina. MR. LYNCH: MR. CAMPER: MR. WAGNER: And we've had that problem already. Yes, that's right. You also said something about
talking about therapy exemptions and how does a user go about getting an exemption for therapy. discuss those things, too. inside here for that? of this morning. You said you wanted to
Did you want to give guidance
You had mentioned that at the beginning
I wrote that down in some notes. Oh, for HDR concerns? It's therapy exemptions. How does a
MS. TAYLOR: MR. WAGNER: user go about it? stages.
I presume what we were talking about is in
The first stage would be exemption for therapy under
30 millicuries, over 30 millicuries, and how does a user -What guidance do you give the user about applying?
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 the hood. MR. WAGNER: It sounds like a really bizarre inpatient. MR. LYNCH: hospital right there. MR. CAMPER: Could you administer in the van and If you had an arrangement with the CHAIRMAN SIEGEL: MR. WAGNER: Over seems out of the question.
That's out of the question. I don't see how you would
CHAIRMAN SIEGEL: physically do that. MR. WAGNER:
You couldn't do that.
That would be
then take them into the hospital? MR. WAGNER: I guess you could. Are you supposed to be moving
CHAIRMAN SIEGEL:
the over 30 millicurie patient through unrestricted areas from the point of administration to the point of confinement? I
don't think you are, and nearly all therapy is actually given in the room. MR. LYNCH: No. Some therapy is given in the
nuclear medicine department, and they walk in the halls going up. CHAIRMAN SIEGEL: MR. LYNCH: MR. WAGNER: MR. LYNCH: Yes. Yes, some people do it backwards. I mean, they do it where they have Cancer therapy?
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 situation, though. about this? Do we really need to give them guidance
I mean, is this really an issue that you see? MR. CAMPER: Well, I think -- I don't recall that
exactly, but I think what I was referring to was the guidance with regards to an exemption for under 30. MR. WAGNER discussed that already. MR. CAMPER: I think we have, yes. All right. For under 30. I think maybe we
So we've discussed that issue. CHAIRMAN SIEGEL: Were there any other comments
that came from these letters that were sufficiently important that we should look at them? MS. TAYLOR: Well, we pretty much -Or have we hit them?
CHAIRMAN SIEGEL: MS. TAYLOR:
We pretty much hit them or we've
already included them and talked about them. CHAIRMAN SIEGEL: MS. TAYLOR: there wasn't anything. CHAIRMAN SIEGEL: -- another way to handle it is, Well, I guess --
I'm looking through to make sure
if Lou and I see something on the airplane on the way home, we can send you an E-mail message, since you are accepting written comments post-meeting. MR. CAMPER: Right?
See, Barry, if you go back to the
question you were raising a moment ago, if you go over to
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 35.315, safety precautions, it says, "For each patient or human research subject receiving the radiopharmaceutical therapy and hospitalized for compliance with 35.75 of this chapter, licensee shall provide a private room with a private sanitary facility" as opposed to administering only that private room. Now, you're right, most folks do it that way, but some do administer in the nuke med department and wheel them back upstairs to the private room. CHAIRMAN SIEGEL: The problem is, though, that
that patient instantaneously makes unrestricted areas into -in violation of the 2 mr per hour limit when walking from point A to point B. MR. CAMPER: By definition, you're right. So you really -- although we Right? If
CHAIRMAN SIEGEL:
might look the other way, it really shouldn't be. MR. LYNCH: Well, then you assess that.
they're using a hood situation in the laboratory, that limits exposure to the people that are delivering the dose. take them up the back way in the freight elevator and whatever. MS. TAYLOR: One comment we received -Well, I mean these get They
CHAIRMAN SIEGEL:
sometimes a little bit crazy, as you know. MS. TAYLOR: We received two comments about
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 vehicle. about. delivery of material to a van, and we said it had to be with the presence of mobile service personnel. We received a
comment from Region 2 and one other region and asked why we wouldn't allow it, if the van was not occupied, because we do in fixed facilities. I think part of our reasoning was that it was a fixed facility within a building. disappear and what have you. It's not going to so easily
So that is in a couple of these
comments, and we decided not to include that; because we didn't want that. That's really the only one we didn't talk about. MR. WAGNER: Well, there's an issue here on item
5 of delivery to a van without the presence of mobile service personnel should be acceptable if the licensee has established adequate security and implemented delivery procedures to ensure the material will only be delivered to their van. If
the van is not found, delivery driver will take material back to the supplier. MS. TAYLOR: That's what I was just talking
We were just concerned -MR. WAGNER: MS. TAYLOR: Makes sense to me. I mean, it would require the
pharmacy to have a key to the van. MR. LYNCH: But now you're talking about a
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 property. MS. TAYLOR: MR. WAGNER: Versus a permanent facility. Well, if they have a secured area, I
mean, where they store things overnight or whatever, what's the problem? it to the van. They take it into the van. They put it in there. The driver delivers
It's inside there. The door is
It's a locked door.
They come out of the van. What's the problem?
locked and they leave.
We're talking
diagnostic materials, for the most part. MR. CAMPER: arrangements. MR. WAGNER: Oh, of course. Of course. I mean, It depends upon the security
the driver would be escorted to the van, open up the van for him. He puts the case inside the van at the designated They walk outside. They lock the van, and they
position. leave.
MR. CAMPER:
Is that adequate in a situation
where a van could easily be broken into? MR. WAGNER: Well, not, not if it's easily broken
into, but it depends on the security arrangements. MR. CAMPER: though, arguably. MR. WAGNER: But it's located on private Well, I'm saying, it's a van,
It's at a hospital. MR. CAMPER: So then that depends upon what kind
of security arrangements exist for oversight of the van while
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 problem. MR. WAGNER: Yes, right. It has a lot less to do with Stealing cobalt 60 pieces of it's on those premises. MS. TAYLOR: Well, now we've got one TAR in with
an exemption that they're going to have to park the van in the street, public street, because the van physically will not fit, and that would be a concern; because you're much more -MR. WAGNER: in their application? CHAIRMAN SIEGEL: There's not a real big black Of course. Why can't they put that
market out there for stolen technetium. MR. WAGNER: MR. CAMPER: No, there's not. No, but the idea that technetium, a
case of technetium, finds itself in the public domain because some kid breaks into a van and steals it is a problem. very least, it's a public perception problem. CHAIRMAN SIEGEL: It's a public perception At the
CHAIRMAN SIEGEL: reality than anything else. steel is one problem. MR. CAMPER:
Oh, I understand. Just, you know, put a lot of
CHAIRMAN SIEGEL: word salad in.
It will be fine. No, you're right. Even in the worst
MR. CAMPER:
case scenario, if the kid steals and injects himself with it,
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 frequency. big deal. Right? It's like having a nuclear medicine
procedure, but by the same token, in terms of the eyes of the public, the idea of this case of radioactive materials in the public domain is not acceptable. MS. TAYLOR: You'll have a pharmacy that, oh, I
forgot the key or this key is not working for some reason, well, they leave it in the hall overnight, leave it with the van, that's going to be more -- You can't trust completely or put the onus completely on the pharmacy that they will take that material back and not just leave it at the doorstep, because they were told this is an urgent delivery, we absolutely have to have this. MR. WAGNER: In human society, we're never going
to have 100 percent guaranty of anything, but I still think we're talking about tornadoes here. We're talking about rare
instances, things that are highly unlikely, and there's a certain level of security you can supply, but you will never be able to supply absolute 100 percent, guaranty that something won't happen somewhere. MS. TAYLOR: And that's part of the reason with
this facility you're not so concerned, because it's within a building in a hallway versus a van, it's just sitting on the step in the parking lot. CHAIRMAN SIEGEL: Tornadoes are increasing in
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 MR. CAMPER: In mobile home parks especially. No, no, seriously.
CHAIRMAN SIEGEL: MR. CAMPER: MS. TAYLOR:
No, I know they are. Well, I guess this is a policy
issue, Larry, that we need to talk about inside. CHAIRMAN SIEGEL: In yesterday's New York times
there's an article, an extension of this thing that says that there is no pretty clear evidence that the greenhouse effect is really occurring, and one of the things they have observed is that precipitation is now occurring with increasing frequency as huge dumps in large storms of over two inches of precipitation, rather than the more gentle types of rainfall we've had in the past. MS. TAYLOR: Yes, I read that. It said that the greenhouse
CHAIRMAN SIEGEL: effect is increasing.
I mean, why do you think we've got up It's clearly because of the
to Hurricane Marilyn this year? greenhouse effect. MR. WAGNER:
Obviously. All right. So I think we're
CHAIRMAN SIEGEL: not certain about -MS. TAYLOR: MR. WAGNER: uncomfortableness. MS. TAYLOR:
We'll take this up with management. I just have a level of
With it being in a parking lot.
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 discussion. MR. WAGNER: I've seen these sorts of operations,
and I think it has to be taken on a case by case basis. MR. CAMPER: To a point, we certainly have a
concern about security when this stuff is out on the parking lots or even on the street, and you're right, though. What we
should be looking for is what security arrangements exist. What is the mechanism that the van operator or the van operator in concert with their client are going to put in place to adequately secure the materials against theft, loss, etcetera. MR. WAGNER: One of the things -- They actually
may have a camera out there which is monitoring the van from the security desk, you know. That's one thing that you might
have, and you certainly wouldn't want to have that if it was in a residential area. You had the van located in a
residential area, you know. CHAIRMAN SIEGEL: MR. CAMPER: Is that it? CHAIRMAN SIEGEL: off the record? MR. CAMPER: MR. WAGNER: your concerns. CHAIRMAN SIEGEL: Shall we adjourn the morning We're still on the record. Well, in any event, I understand Are we still on the record or Are we finished?
Well, we're still having a bit of
168 1 2 3 4 12:01 p.m.) session. (Whereupon, the Committee recessed for lunch at