ML20207L691
| ML20207L691 | |
| Person / Time | |
|---|---|
| Issue date: | 02/18/1999 |
| From: | NRC |
| To: | |
| References | |
| RULE-PR-35-MISC NUDOCS 9903180231 | |
| Download: ML20207L691 (119) | |
Text
g
, gg;ggj
_gdlh_:D JJ '
. jAf aqq sf 4,y g%g%ggij f
g s>g 4me 92 W g p4 gg.
qgy j
y]
i
)
j y
H'
+
~w g,
ey.
y.
g
.p y
. p; i ;;
s l
'.7 d.
- 7,{.l.
1 o L
! A I
k i,s c
I J-
'd, hi "E
i j
l 4L n @J@'"j i
p d
s t
$ M F
i.
{
t 3
~
1
-'4 m
l
/p,' - 1
( $M[g
~ <
1
~
g
,e 4
t A
.' 3 5 l!
x y
'6 p,
3 9
g.
3 v ;
g g
h
- r j m_ a j jp e
/
~
g[7 e grgkjej.
i)gh;"jg M,ggp p
. p!
,t a
EhhpP 5
%[d@FF
- g! n: y$,ag L
egE W4Bsfa w mn! mpq e -
a
,fJ h,
7 % $J f _L t y%,j{$h,,f_@
M,$ j W
h Q9J ws M
ub x % e, w# w,@ e a,M $ k s ses e
k dgyx.
lhgggkad%WWYNs'sphN'd/W ij?!I $
3MW MMr PDR 10CFR g na 37?ihi@iSVER$@@@Ehhgd[h@hh(h4Pyd}::%M j
J5 "0 ' ?
ht
$hV Yi PT9 7 PDR ia hkkhk$$
%g,- *
)
y '
si v
- h. _
tF' iiu' E
\\
p' i
"! ? -
w sl~ _ i
' (' N $
' ~p r
m
,. +
s i
2 g;qtu'jj_% n.
," y:, *
.g X-l ' N 3:
.i 1
y-pqq.y,
7
,e j
w ::
e:?C. +
_,ff,
-f',
C..
t 3
1,.";,
g e.,,,...^
4 t.
x,_
..t Jip f OFFICIAUT.RANSCRIPT10F - PROCEEDINGS L gj my, i;D_ c ' : ' NDNiTED;STATESiOFXMERICA nr n,
o
~.
y
- 4, v
?:R:( s
}. y '
\\
j
,}
i r
[?, ?NUCLEARn.s.EGlULAT.ORY3 CdMMISSION--
E
<i
)'
[df 1
s 4.., t
^.c 3 1 f&,a~'
..,/,
- n. Dn8 8 " ' 'w s):- _,
\\ (:'
t f t-
^;3 t-
+
(
h# ]I n:%.' 4_ f I' q
y i
r L
r$
- 1:['
1
^
1 y
~
g a; m. '
< - s-
~
4.,
,s y
C 2
- . I !
yg,
<m JTitleD,.pg, tP, ART (35 PNBLIC$1E5 TING.
-1
?Vi i
lU n:
w -
r
..n p;l:
4rt
.s' a
.. m w 1 t
- y..
- q p.
1*
- W
\\WITH'REPR$SENTATlV8S OF
~7 en
~
u
['
STH,ElfEDIb L BOARDS i
M i. i, y.
m Y.;.w 4
i; l'_
- 2(
.Q.
y.
$s_<
r w.
v
-t y
1
.,,,a i : :f - l ;j _.
, 'i
- g. ' I"'.j
gC j
3
\\ ~
,,i j
i
.),
.J
,.h f,
4 s
C;
,!i f,n
- 7. s, 4
a 3.
m s
m.
N' c.
o
- i /.
.s, s.-
s v.,>: t -
rp.,
,i :. (
4,=
y q.g.
-y-e
. :y.
o t,,
8 m.
- n.
ep s
v 1 =..
C2 -
w e;p.
.,. w
,, w 1
w o
'44.
- j ;.
d <yd<e@
1 Y
d
- g
.1 c
p
~
c',
1 a,
_E >
t 4_
% ' 2' of jf ' ~
(
9 5
s w
j 4
'g-g m
' g.
yM'
~ '
4' a'
,. - a c,
n, l' A t w :
l
,s s
s r
i t
t, y,. - '
2 b,
/
t
,T' U.2..
f r,,
g i
- r:;
L'
~
nk:,
s, w.
. s.,
a
,r J
a
?
e :
p c^l!!
- fi l
r
~
Work Order No.:
n.
~
1 l'
r.
a
,r,-
r i
g e.
t o
y 9.t
..a...
r a-we i
_s S
ILOCATION:
3 g'
5 Rockville,MD.
+
- 7 n8
) !:
wW s
E' ';:
!.'+,. + ;
j-t s
'1 ;
.) 4 v
s S
~
N p
4-4
.si.
s,.
]'
t f
I f
gfDATE:', qThursday, February 18,19993 S PAGES: 239 - 355 -
t
, o,
- <o,
~
d j f fl '.i;, '
l1; Q(
a 7:( t e
t t
u e
. t. :
,. p.
r
>i ll* \\.ll t t
'~
d
,<..z q.;,
s j ; _,
u, s; s,-
?
i
^
[/
ANN RILEY & ASSOCIATES, LTD/
'1925 Connecticut' Avenue,NW, Suite 1014 r
' (
^
,,. Washington, D.C. 20036 -
- mx
~ (202) 842-0034 w
W $
9903180231 990218 A":cU: '*' '
u y 1
-t
[ l d[
- yY', U l'
'..) \\_
- i: V
" ?_
- .., y.
a r
(1
\\
2 a-
i.
239 1~
UNITED STATES OF AMERICA D
2 NUCLEAR REGULATORY COMMISSION 4
D 3
4 PART 35 PUBLIC MEETING WITH 5
REPRESENTATIVES OF THE MEDICAL BOARDS 6
s 7
U.S. NRC 8
Two White Flint North, Room T2-B3 9
11545 Rockville Pike r
10 Rockville, MD 11 Thursday, February 18, 1999 l
12 The above-entitled workshop commenced, pursuant to 13 notice, at 9:08 a.m.
14 PARTICIPANTS:
15 ED MAHER 16 FRANS WACKERS 17 RICHARD FEJKA 18 MIRIAM MILLER 19 ALAN H. MAURER 20 CHARLES ROSE 1
21 PETER MOORTON 22 PHILIP O. ALDERSON 23 MARK RAYMOND 24 WALLY AHLUWALI 25 DAVID COOPER O.
ANN RILEY & ASSOCIATES, LTD.
Court Reporters l
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
l
l 240 1
PARTICIPANTS:
[ Continued) 2 N. SUNTHARALIGAM 3
JACK BASKIN I
4 PETER S. ROSS 5
6 7
8 9
10 11 12 13 14 N.
15
]
16
-17 18 19 20 21
'22 1
23 24 25' ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,-D.C. 20036 (202) 842-0034
241 1
PROCEEDINGS r%( ).
2
[9:08 a.m.]
3 MR. CAMERON:
Good morning everybody.
We are 4
going to get started and before we go to a proposed agenda l
5 for this morning, we have some new participants with us, and 6
I'd ask them to introduce themselves.
Suntha?
7 DR. SUNTHARALINGAM:
I am Dr. Suntharalingam, 8
Emeritus Professor from Thomas Jefferson University.
I am 9
attending here as Executive Director of the American Board 10 of Medical Physics.
11 MR. CAMERON:
Okay.
Thank you, Suntha.
We had a 12 good discussion yesterday of a lot of issues and if you need 13 a reprise of yesterday at any time during our discussions, 14 just ask, and we also have Dr. Ross, right?
/\\
()
15 DR. ROSS:
I am Peter Ross.
I practice 16 endocrinology in Fairfax County, a Virginia suburb of 17 Washington, and I am representing the AACE.
18 MR. CAMERON:
Okay, and everybody knows what the 19 AACE is?
20 DR. ROSS:
The American Association of Clinical 21 Endocrinologists.
22 MR. CAMERON:
All right.
Now we really know what 23 it is.
24 Yesterday there was, and it is still back there, a 25 cart full of all the comments that came in on the proposed ANN RILEY & ASSOCIATES, LTD.
\\
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
~.
-. -. ~
. -. ~.,
242 I
rule that related to training and experience.
I am pretty 2
sure they were all the comments on that, so if you did not i
\\-.
3.
pick them up, they are back there.
If we run out I will 4
make'sure that Cathy --
5 MS. HANEY:
Thanks.
He's great at volunteering 6
me.
The packages that you have, those are the comments on 7
training and experience from the boards.
There are a whole 8
other grouping of comments on training and experience, but 9
those are submitted by individual members of societies or 10 whatever, so we just xeroxed the ones that are of the 11 boards.
12 The majority of the comment letters are on the NRC 13 website, so if you would like to see all the comment letters 14 there, you can go to the website.
There's probably about 75 O(,/
15 percent of the letters up right now.
We will continue to 16 get the rest of the letters up on the website in the near 17 future.
They are all available in the public document room 18 though.
19 DR. WACKERS:
What is the website?
l 20 MS. HANEY:
What's that?
21 DR. WACKERS:
www.nrc.com -- com or --
i 22 MS. HANEY:
gov -- g-o-v.
If you look for it 23 under Rulemaking, if you can find your way through there,
.24 you'll find the website for this specific location for Part 25 35.
L - ( -)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
l
i l
243 i
i l
1 MR. CAMERON:
Okay.
In my conversations with
{
()
2 Cathy this morning the NRC thinks it probably has heard the 3 -
information it needs to hear about the exam point about 4
developing, approving exams and about exams in general, but 5
I want to give all of you a chance -- if anybody has any 6
comments that they want to give on yesterday's session we l
7 will start off with that, but the bulk of today's discussion 8
is going to take a look at this particular option -- in 9
other words, the training program option as opposed to the 10 exam option, and for Suntha and Peter's benefit this was the 11 option that was in the proposed rule in terms of the boards 12 and the so-called equivalent pathway.
13 The Staff has been working on developing the draft 14 final rule and has come up with an alternative approach
('T-I
\\,/
15 which also has an equivalent pathway, recognition of the 16 board -- an equivalent pathway, but the focus is on approval 17 of a training program rather than approval of an 18 examination.
19 So what we would like to do today is to focus on 20 that second approach and particularly try to identify what l
21 the NRC should look for in approving training programs, what 22 they should request from people who want training programs l
l 23 approved and most importantly, what types of resources, both 24 NRC and in the medical community would be involved in this 25 type of option?
l O)
(
AJDi RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 l
(202) 842-0034 l
l
.~
244 4
1 We sort of were pulled in two directions, I think,
()
2 yesterday where we started off with a conclusion I think 3
that there would be less resources involved, at least from 4
the NRC point of view, in taking this approach than in the 5
approval of the exam and examining organization approach, 6
but Alan and someone else cautioned that that may not be a 7
good assumption, so we would like to look a little bit 8
further at this issue and Cathy has a straw man that we are 9
going to pass out that will help guide us along on that.
j 10 Also, there is this other issue is how much 11 reliance in using the second approach should be placed on 12 AOA and ACGME blessing -- I don't know what the right word 13 is for that -- but that is where I thought we could go this 14 morning.
C\\
(,/
15 Barry, do you want to say -- go ahead.
16 DR. SIEGEL:
I want to comment specifically about 17 that.
18 MR. CAMERON:
Right.
19 DR. SIEGEL:
Because I didn't have a chance to 20 comment on what Alan said yesterday.
21 I agree with Alan's notion that if the NRC has to 22 get into the business of effectively functioning like the 23 ACGME or the AOA and take on the job of the residency review 24 committees for a large number of individual programs, the 25 NRC has a very large job indeed, but if the NRC delegates ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
245 1
that authority to the ACGME and the AOA, then the NRC's job
~(
is greatly reduced and to the extent that a vast majority of 2
i 3
the programs can come in under ACGME or AQA mechanisms.
4 Right now we know radiology, nuclear medicine, 5
therapeutic radiology can come in with no difficulty.
If 6
cardiology and endocrinology can line up their ducks so that 7
those things become part of the special requirements, then 8
the NRC's job becomes very, very small and they don't have 9
to do much beyond reviewing what is in the Green Book and 10, knowing that someone who was in one of those programs had 11 that training because the preceptor said they had that 12 training.
13 DR. MAURER:
I was going to comment on that 14 because I brought it up.
I agree with Barry's comment.
I 15 think some of the areas that we are talking about here are 16 not traditional ACGME site issues.
Again, I am going to put 17 it in the context that I think it -- and this was reiterated 18 yesterday as part of the NRC position -- that the radiation 19 safety portion of the training has to be integral to the 20 clinical training, because you can't divorce use of 21 radioisotopes outside of the clinical setting from what 22 happens with patients in the real world.
23 I was thinking of things that would be involved in 24 a training program that are not normally a part of --
25 actually fall more under the purview of what is an NRC site 1
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 i
246 1
visit.
Would the trainees get training in security?
Big n
)
2 issue -- about how radioisotopes have to be secured.
You U/
3 can't be in a patient examining room with a dose in the 4
other room, leave it unattended.
It has to be secured at 5
all times.
6 What kind of onsite quality control would we have 7
of those things?
The basics of a radiation safety 8
protection program in the clinical setting would have to be 9
site inspected and visited if the NRC wanted to hold people 10 to those as a part of their training requirements, and that 11 is not a traditional part of an ACGME site review.
12 You could say, well the preceptor can certify it, 13 but this is a whole new part of clinical experience.
14 MR. CAMERON:
Can I just stop at this --
p)
(,
15 DR. MAURER:
I am saying clinical experience with 16 radiation safety --
17 MR. CAMERON:
Right.
18 DR. MAURER:
I am not talking about clinical 19 training.
20 MR. CAMERON:
I can see this is going to be a 21 great discussion, because everybody wants to get to it right 22 now but --
23 DR. MAURER:
That is where I see the problem, 24 because it is opening up a new set of things for the ACGME 25 to start to worry about.
/m
(
)
ANN RILEY & ASSOCIATES, LTD.
\\'
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 247 l
1 MR. CAMERON:
Okay.
You bring up a question that i( )
2 I want to ask the group, but before we get into this
.3 Approach 2, I want to make sure that there's no lingering l
4 questions about yesterday's examination issue and when we i
5 get to this Approach 2, Barry sort of got us into what 6
process could be used but the answer to that question may be 7
dependent on the types of issues Alan is bringing up, what I 8
am calling the content issue.
9 I mean doesn't how you are going to do this depend 10 on what the content of the training program is supposed to i
11 be?
So maybe we can start with that particular issue, but i
12 let's just go to the -- is there anything from yesterday 13 that anybody wants to get on the record?
Chuck?
14 MR. ROSE:
His comments are excellent, right, but
(
15 I think before we start this discussion of how to approve a 16 provider, and you brought up the issue of the content, which 17 is excellent, but I think we should clarify for everybody 18 exactly what content is it we are talking about here.
19 Under the first proposal, we were talking about 80 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of didactic and 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of handling.
Now we are 21 talking about four months, period.
22 MR. CAMERON:
Right.
Cathy, when we get to this 23 discussion -- I keep trying to pretend that we haven't 24 gotten to the discussion yet -- but I think it's fiction, i
25 when we get there, Cathy is going to give us some of the
(
ANN RILEY & ASSOCIATES, LTD,
\\~
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
_. - ~..
I 248 I
working group thoughts on this particular content issue, and ym
( )
2 then we can get into the discussion.
3 Anything lingering from yesterday?
l 4
[No response.]
5 MR. CAMERON:
All right.
Cathy, do you want to 6
put up the material that you have on content?
7 MS. HANEY:
Okay.
8 MR. CAMERON:
Is everybody agreeable to that, to 9
starting out with, well, what should be in this training j
10 program?
Okay.
11 MS. HANEY:
Let me first say'that what I am going
'12 to put up on the screen is not the result of the working 13 group -- not that I want to contradict Chip, but this is 14 what I wrote down at 7:30 this morning to give us something (O_,/
15 to talk about.
16 So let me just enlcrge this a little bit --
17 actually is that okay, or want it a little larger?
18
.MR.
CAMERON:
It's all right.
19 MS. HANEY:
Again, this is strictly my work for 20 the sake of discussion, so it is not etched in stone by any 21 means.
What I wanted to do is give us a starting point for 22 today's discussion, and I will have copies of this.
They 23 are making them now, so hopefully during the next couple 24-minutes they'll come down.
25 I focused in on the use of unsealed byproduct
( ~\\
i\\ ')
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
249 1
material for imaging and localization.
This would be your 2
35.200 use, not unit dosage but someone that wanted to use 3
all types of material under 35.200.
4 If I was going to start approving a training 5
program, what would -- this is strictly what looks good so 6
you can tell me that 10 should be 20 or 40, whatever.
If I 7
was going to sit down with an application in front of me 8
today, what would I look for if I wanted to approve it and 9
the first thing I think I would look for is the instructor 20 qualifications and again these -- you know, help me on 11 whether I am on the right track or not -- I would think a 12 minimum of a BS degree of five years' experience in teaching 13 the subject matter.
14 Then the next thing that I would look for is 15' course content.
If you remember from what you got on 16 Friday, we were talking about just a four-month sort of 17 training program where we did not specify hours in any l
18 specific area, but I would estimate, say, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of 19 didactic training and that would be split between the 20 physics and instrumentation, protection, chemistry and 21 biology.
22 What would be in the rule text would be just the 23 subjects but not necessarily the areas because I would want 24 to stay away from getting very prescriptive in the rule if I 25 can so that programs would have some flexibility, and then I l
ANN RILEY & ASSOCIATES, LTD.
l Court. Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 i
1
250 1
would look for is there criteria for evaluating the
()
2 student's understanding of the material.
3 I started to type " exam" and then quickly deleted 4
that this morning.
I would feel comfortable relying on the 5
preceptor's st6tement at the end of the program saying that 6
this individual had mastered the skills.
7 Then the next thing I would look for would be the 8
supervised practical experience.
Again, we would start out 9
with the supervisor's qualifications.
At a minimum a 10 supervisor would have to be an authorized user for that type 11 of use.
"ow in the case of a 35.200 user, you could 12 probably have someone that was used to dealing with 13 therapeutic unsealed byproduct material also as a 14 supervisor, but again this is just a rough draft at this (Gs) 15 point.
16 Then I would be looking for some type of 17 commitment that the authorized user would be providing 18 direct supervision, and by this I mean physically present in 19 the department.
A lot of time NRC encounters situations 20 where the authorized user may not be in the office very 21 much, but I would be looking for very much a hands-on 22 approach between the authorized user and the individual that 23 was undergoing the training.
.24 Then I would look at the environment.
At a 25 minimum the facility where the training is going to take r~
' (x)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washingten, D.C. 20036 (202) 842-0034
251 i
1-place they have to have an NRC Agreement State license for
,e m
(
)
2 that type of use.
Again, all of this would be focused very 3
much in on that type of use the individual would have.
I 4
really would not' care if it was in a university hospital or 5
private office setting.
Really the big key is the first
)
6 item, that they do have a license.
7 Then as far as a commitment to what sort of skills 8
the individual would have coming out of this program, and j
9 this is where Alan's remarks would really come into play, I 10 pulled for the sake of discussion today from the rule the 11 items that were there.
12 You had mentioned transportation.
That really 13 would fall under the first bullet, where it says (1) -- not 14 a bullet there but, you know -- and maybe this list should
()
15 really be expanded a little bit to cover so ne of the Part 20 16 issues, although the current rule does not get specifically i
17 into looking at Part 20.
It uses a lot of the same language 18 that we have had here.
19 Again, the last thing I would look for is the 20 criteria for evaluating, and again I would rely on the 21 preceptor's statement.
22 With that sort of review process in place, I went 23 into trying to decide what would be the resource 24 implications, and if we were approving a board or if we were 25 approving a component of an ACGME or an AOA approved b
ANN RILEY & ASSOCIATES, LTD.
\\~s' Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,'D.C. 20036 (202) 842-0034
252 1
program, I would say that we would not need to do an onsite f%
q )
2 visit and our paperwork review in the office would be 3
approximately 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />.
For a non-ACGME approved component i
4
- of a program, I would think the paperwork review might be a 5
little bit more extensive, somewhere around 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> in the 1
1 6
office.
i 1
7 Under this case you would probably want to do an l
8 onsite visit.
I'm saying two days including travel and then i
9 approximately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> follow-up in the office.
This also 1
10 allows for some give-and-take if sufficient information 11 wasn't submitted the first time.
12 Then in calculating the resources, a rough 13 estimate on the number of approvals that I am going to need 14 to give, we went through the coards and the numbers after I O's,)
15 think there might be three areas under ABR that I would be 16 approving -- one under ABNM and then it goes down there from 17 the list -- and then the Canadian boards I really wasn't 18 that familiar with, and then looking specifically under 19 ACGME, the four areas.that we would probably give approval 20 and under AOA the three areas that we would give approval.
l 21 So, with that in mind, I guess there really are a 22 couple issues here, Chip.
One is if I have picked the right 23 criteria for evaluating the programs, and then next whether 24 I am in the right ballpark as far as the hours.
25 MR. CAMERON:
I think what we'll want to do now i
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
253 1
that you gave us that overview is go to what I refer to as
(%
(
)
2 the content, okay? -- A and B, if you can get all of A and B
.3-on the screen, and then after we are done with content we
)
4 will go to those process issues that you have on the other 5
page.
r' 6
Before we get into that, we have our final 7
panelist with us, and David, could you just introduce 8
yourself?
9 DR. COOPER:
Yes.
My name is David Cooper.
I am 10' an endocrinologist at Sinai Hospital in Baltimore at Johns
~
11 Hopkins and I represent The Endocrine Society and the i
12 American Thyroid Association.
13 MR. CAMERON:
All right.
14 DR. COOPER:
We are interested in radioactive (N
j
\\ms) 15 iodine primarily.
16 MR. CAMERON:
Okay, thanks for driving down frca 17 Baltimore.
18 DR. COOPER:
The traffic was brutal this morning.
19 MR. CAMERON:
I can believe it.
Okay.
Is 20 everybody comfortable with starting on content, and Suntha, 21 do.you want to start us off on that?
22 DR. SUNTHARALINGAM:
I have a question or 23 clarification.
24 MR. CAMERON:
Okay.
25 DR. SUNTHARALINGAM:
It says training of i
i es
)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
254 1
physicians or training of any individuals?
(~;
2 MR. CAMERON:
Good point.
3 MS. HANEY:
This would be specifically for an authorized user that wanted to use material for imaging and 4
z 5
localization, but I think when we are discussing this I 6
would like if possible for you to keep the discussion
.7 general enough that the same philosophical approach to 8
approving an authorized user could be used for approving a 9
pharmacist or a physicist or a radiation safety officer.
10 MR. CAMERON:
Okay, and anybody have any points on 11 that?
12 DR. SUNTRARALINGAM:
Then some of the boards 13 listed address non-physicians also.
14 MR. CAMERON:
Good point.
We'll bring that back 1
t
\\
(,)
15 when we get there.
Did you have a point on that 16 clarification?
17 DR. MAHER:
Well, just that the RSO if they met 18 these requirements they would be considered an adequate RSO 19 for the facility?
Correct?
i 20 MS. HANEY:
Correct.
21 DR. MAHER:
Okay.
22 MR. CAMERON:
All right.
Okay, Chuck, content?
23 MR. ROSE:
Yes.
Currently we require 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of 24 course content.
The proposed regulations that were 25 published and we held the hearings on, those regulations l
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 255 1
dropped that to 80.
Now we arc Lw> king at 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> to train
()
2 someone to be an authorized user and to be a Radiation 3
Safety Officer, right?
4 My feeling is, after having experience with more 5
.than 1000 physicians -- Radiation. Safety Officers, 6
pharmacists, and et cetera -- that is not enough.
It is 7
just not enough.
8 So now we are looking at -- in the order we are 9
looking at about 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> of handling experience, which is 10 very difficult to document and very difficult to know what 11 is really being taught, right? -- but more handling 12 experience than we had in the past, and we have in essence 13 practically no education.
We have changed that already.
I 14 am glad that my comments are being taken here, but --
k 15
[ Laughter.)
16 MR. ROSE:
-- of if that is just the computer by 17 itself --
18 MS. HANEY:
No, it's me.
19 MR. ROSE:
-- but I just don't think it's enough, 20 I really don't.
j 21 I think that for course content, because physics 22 and instrumentation can mean so many different things, 23 chemistry, et cetera, you can't go through Part 20 in 10 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, right?
You can't go through Part 20 in 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> and 25 have people understand what is in Part 20 -- even if we
[]
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
256 l
1 throw out the majority of Part 35, and if we are going to
[)
2 say you don't have to know this stuff, then fine, but if we N-3 want people to be as well-trained or somewhere near as 4
well-trained as supposedly they have been in the past, then 5
those numbers have to go up substantially, at a sacrifice 6
perhaps of the 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> that are left in handling i
7 experience.
I 1
8 I really don't believe after being in this field 9
training physicians for over 40 years, right? -- I really de 10 not believe that that 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> will turn out to be anyching 11 more than the farce that the 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of handling is now 12 regardless of the boards --
13 MR. CAMERON:
Chuck -- okay.
Let's follow this It course content thread now.
We have other issues here, but 15 let's concentrate on this.
16 MR. ROSE:
With regards to the actual content of 17 the course, I think it should be outlined, as I presented 18 yesterday, like you would in any educational program.
You l
19 have goals, you have objectives on how to achieve those 20 goals and I don't think that you can have a program without 21 evaluating whether or not those goals have been met.
That's 22 a standard educational format.
It is not standard medical 23 format.
It is not standard residency or fellowship format.
24 It is standard educational format that every 25_
college, university, and every other educational body in the l
l f-s..
't ANN RILEY & ASSOCIATES, LTD.
N-Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
,~
n
257 l
1 nation has to comply with to have a legitimate educational n) 2 G'
program so they know what is accomplished, so I think that
(
'3 that curriculum should -- for physics and instrumentation or
'4 take radiation protection for example, there should be goals 5
as to what you want to accomplish and objectives as to how 6
you reach those goals.
7 MR. CAMERON:
Okay.
Let's let other people 8
comment on that.
Let's go to Frans and then we will go to 9
Phil.
Frans.
10 DR. WACKERS:
I think what you outline here I 11 think will give you a good idea how to evaluate a program 12 and I would switch it the other way around and I have done 13 that in the past -- what are you going to teach them -- and 14 I think in the components you have here for radiation j
)
15
-safety for physicians.
I think all the components are 16 there, and I have asked our Radiation Safety Officers and 17 physicists, well, how much time do you need to teach that 18 and I think that is the way --
19 MR. CAMERON:
Can you push the microphone a little 20 bit closer to you?
21 DR. WACKERS:
I'm sorry -- so what are you going i
22 to teach and how much time do you need for that?
That is a 23 better way than just say, well, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> because it doesn't 24 sound like a whole lot.
25 We started the discussion, there's a content for i
l l
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 I
- ~.
258 1
ensuring that people know about radiation safety?
Yes, I (o) 2 think this is the appropriate way of doing it, and then you 3
go backwards and you say, okay, how much time do I need to 4
teach that?
You will find that it is not 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />.
It's 5
not even 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> -- a physicist can teach that in about 50 6
hours, then he is running out of sue :ct material.
7 MR. CAMERON:
So you are sort of echoing the goals 8
and objectives type o" approach.
9 DR. WACKERS:
Right.
Let's first look at the 10-content.
I totally agree with that.
11 MR. CAMERON:
Phil?
Content?
12 DR. ALDERSON:
Yes.
I think that the content that 13 you, Cathy, have suggested here is good content.
I think 14 the skills needed to be mastered are good.
I think that it (A,,/
15 is not appropriate for us to continue to try to equate that 16 content material with the specific number of hours that we i
17 are talking about in this overall program, and it almost is 18'
-like, you know, like I didn't say what I said yesterday.
19 We talked about an integrated experience, because 20 that is the world in which we-live.
That is the world in 21 which these things are applied, so 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> doesn't mean 22 they are going to have 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> of handling experience.
It 23 means they are going to have an integrated experience of 24 handling within the context of the work they do in the 25 environment in which these things are applied.
1 l
l I
()
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
l 259 1
I don't like to hear it keep being restated that
(~%
( )
2 way ?.duse some of the new people here will think that is 3
what we agreed to yesterday.
We didn't agree to that at 4
all.
We said something quite different than that, so I just 5
want to be on record -- and also we didn't say that that 6
doesn't involve classroom.
In fact, the idea is that the 7
integrated experience would include the classroom 8
experience, but the content itself -- I think that content 9
is adequate.
10 MR. CAMERON:
Okay.
We will just underline that 11 point that you were emphasizing is that the whole idea of 12 the training being done in the clinical context.
13 DR. ALDERSON:
It really makes -- you know, we 14 just talked about it for the longer program but in essence
-15 it probably makes sense for the shorter program too.
I mean 16 if they are going to be logical, you know, and we didn't 17 really talk -- I don't want to get you off into that right i
18 now but it's logical that it might make sense for that too.
19 It's all in a clinical context.
It may be a context of 20 endocrinology, it may be the context of cardiology or 21 radiology, but that person who is only going to use unit 22 doses also operates in a clinical context.
23 MR. CAMERON:
Okay.
Let's go to Ed and then we 24 will go to Alan.
Ed?
25 DR. MAHER:
Yes.
I would say for the license or
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025-Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
260 authorized user that this training may be adequate and the 1-t 2
boards are probably in the better position to do that, but I L
3 would say as the RSO, I would go on record and say that 10 4
hours of radiation protection to cover all the Part 20 --
5 you couldn't read Part 20 in 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />, never mind if you 6
understood it.
It's just woefully inadequate for the RSO 7-function.
8 MR. CAMERON:
So for an RSO function --
9 DR. MAHER:
And I would further state that there 10 needs to be another block of training for people who are designated as the RSO because they are essentially running 11 12 the radiation safety program in.the hospital.
They are 13 responsible for not only the staff's work.
They are not 14 responsible for patient dose -- that's the physician's
)
15 responsibility -- but they are responsible for the control 16 of the staff doses and also protection of the public, and I 17 just don't think 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> of radiation protection is going 18 to do that.
19 MR. CAMERON:
What would you change up there for 20 the RSO,.and then let me ask Cathy and Barry about that.
21 DR. MAHER:
As a guess I would say a one week, a i
22 40-hour course in RSO only would be I think a start.
23
'Many of us in the university RSO environment have j
24 to go at least that as well as having the educational 25 background to be qualified.
m ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
r~
261 l
1 MR. CAMERON:
Okay.
Cathy, Barry -- comments on n
(
)
2 that RSO issue?
m./
3 MS. HANEY:
Yes.
I don't know if I can address it 4
directly but it really was the dilemma that the working 5
group faced with the private doctor's offices that are out 6
there where it is one physician, one camera, and do they 7
really need to have an individual that meets the 8
qualifications of an'RSO at 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training.
9 We were giving some credit, if you want to call 10 it, to the fact that they were a physician.
They had gone 11 through years of school.
Most of these facilities have a 12 consultant anyway that comes in quarter, so it was --
13 DR. MAHER:
The consultant could be the RSO.
14 MS. HANEY:
-- this extra peripheral --
l
/(_,)
15 DR. MAHER:
if they had that level of training, 16 could they not?
17 DR. SIEGEL:
The problem with that is that a 18 consultant is not available on site very often and the NRC 19 does not like consultant RSOs as a general rule, if 20 possible, because there needs to be someone who can respond 21 to an emergency if one actually occurs.
22 DR. MAHER:
If you're asking for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, why 23 wouldn't a physician go to that course?
Is that not 24 important enough to spend 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> at?
25 DR. SIEGEL:
It is an additional bar to cross for k-ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
t 262 l
1 an single physician practice, and I am sure the
! (q endocrinologists would say that if the only thing they are
)
2 w/
3 going to do in their office is give radiciodine capsules, 4
why do they need the training beyond the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> that's 5
specified for that category of use to be the RSO for their office where nothing else is done but that one activity?
6 7
DR. MAHER:
So for that exception we allow 8
everything else that is greater than that to occur without 9
having the training?
10 DR. SIEGEL:
No, that is not really true, because 11 an authorized user becoming the RSO can only be the RSO for 12 that category of use.
Someone who is trained in uptake, 13 dilution and excretion measurements cannot be the RSO of a 14 facility that has teletherapy.
I'T
(,/
15 DR. MAHER:
Okay.
16 DR. SIEGEL:
Is that clear?
To be an RSO at a 17 teletherapy facility you have -- and a physician -- you have 18 to have three years of training in radiation oncology and 19 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic, so you don't need to worry that 20 universities are going to have someone with 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of 21 training being the RSO for the university.
It will not be 22 allowed by licensure.
23 DR. MAHER:
Okay.
24 MR. CAMERON:
Let's -- am I confused?
Are the 25 numbers different on the screen now?
l ]'
ANN RILEY & ASSOCIATES, LTD.
\\
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
E '
263
.1
[ Laughter.]
~
2 MR. CAMERON:
What is going on?
l (
l 3'
MS. HANEY:
I just changed it to 20.
l 4
MR. CAMERON:
Next it is going to be 40?. I 5
mean -- okay.
Just_ note'that on your sheets it has --
6 MS..HANEYi Time your sheet at 7:30 a.m. on 7
today's date and'then we will give-you a final copy at Noon.
8
'MR.
CAMERON:
Just take all this with a little bit 9
of a grain of salt, I guess.
Alan, did you want to say 10 something?
11 DR. MAURER:
I think Barry clarified some of my i
12 concerns again.
I have often been concerned about the 13 authorized user being.the same as the RSO because I do think j
14 there is a significant different level of knowledge and
)
V 15 training required.
16 Sometimes you can't anticipate the type of problem 17 that may occur at a facility that even is just handling "I 18~
want 31 capsules."
We have had bizarre things happen in our 19 place where I don't think a physician with minimum training 20 might necessarily know how to handle that, so I don't know 21 if it is 20 or 30 or 40 but I think there are differences 22 between authorized user status and just simply being the 23 RSO.
I like Barry's explanation, but I think there are 24 situations in which.I would prefer seeing somebody with a 25' different level of training.
I l
"N ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 j
l 264 1
For comments -- are we only talking course content (f
2 right now or did you want comments on --
l 3
MR. CAMERON:
No, I think we need to follow --
4 let's follow the course content string and then we will go 5
to other components so that we don't get confused, and right 6
now we are on this RSO issue in terms of course content.
7 DR. MAURER:
And that really comes from really 8
going in depth to all the regulations, because I agree it 9
can take you hours and hours to dig through a lot of that 10 material, let alone understand it and have somebody teach 11 you the implications of it.
12 MR. CAMERON:
Okay.
Anymore comments on the RSO 13 issue before we go back to content generally?
14 David, was yours an RSO issue or just general?
'(O_)
15 DR. COOPER:
Well, I suppose it is an RSO issue if 16 there's a contention that a authorized user could not be an 1
17 RSO in a facility that simply is administering I-131 for le example, and all I was going to say is that despite the 19 bizarre things that might happen, there's just never been a 20 case -- ever -- in the history of endocrinology where there 21 has been an incident in the last 30 or 40 years when l
'22 physicians, endocrinologists trained under these particular 23 guidelines have administered radiciodine.
24 MR. CAMERON:
Okny.
Alan, did you have a comment l
25 on that?
i ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 265 1
DR. MAURER:
Well, there are bizarre incidents i
/x (v) 2 that occur.
We have had a recent --
3 DR. COOPER:
We are not aware of them.
4 DR. MAURER:
That's the problem.
We are not aware 5
of them because sometimes they are not looked for.
i 6
We had some recent problems with I-131 capsules 7
coming in where the packaging was being contaminated and our 8
staff was being exposed, and it really took somebody with 9
some knowledge to realize what was happening, contact the 10 provider, who had to go back to the factory.
I mean things 11 do occur, and if you don't know to look for them, you are 12 not going to find them.
That is one of the problems with 13 radiation.
14 MR. CAMERON:
Okay, but we'll still go back to (s
(_,)
15 Barry's basic point.
16 DR. SIEGEL:
I was just going to echo what David i
17 said though, which is that with respect to this individual 18 physician office, endocrinologist or cardiologist or 19 radiologist functioning as the RSO for that category of use, 20 there is no evidence that the system is broken and currently 21 the training and experience required for an endocrinologist 22 to give I-131 capsules or I-131 liquid for that matter in 23 office setting and also be the RSO in the office setting is 24 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> and it is the same that is required in the proposed 25 rule.
f.
)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
1 266 1
Mk. CAMERON:
Okay.
I only want to take RSO j
()
2
-issues *ight now.
Miriam?
2 MS. MILLER:
I just want to talk as an educator.
4
.You know, more.and more educators are getting away from j
5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />, even for the RSO.
I mean someone can learn something 6
in 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> which might take 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> for someone else to
)
7
_ learn, and all our accrediting bodies are getting away from j
8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> and more setting standards that they have to learn 1
9 rather than so many hours.
10 MR. CAMERON:
Performance standards.
I 11 MS. HANEY:
Well, let me jump in --
12 MR. CAMERON:
How do you test that, if I may use 13 that word?
14 MS. HANEY:
Don't test.
We don't test anything.
f n
(,/
15 Let me address Miriam's comment and Chuck's 16 comment.
The rule that the Staff proposed on Friday did not 17 specify a breakdown by hours of physics and instrumentation.
18 It just said four months of training, and you would cover 19 physics, radiation protection, chemistry and biology, and 1
20 you would cover the skills mastered that are up there, and 21 that is all the rule said.
'22 We did that to_do exactly as you -- really because 23 of what you said, that we did not want to specify hours.
We 24-wanted it to be the integrated training environment that Dr.
25 Alderson had referenced, but I went to this level of ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025' Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
~_.
267 L
(
1 breakdown this morning in essence because of what I heard l3 2
yesterday as people would be asking NRC, what do you want in V
3 order for you to approve the program?
4 This was just, as I said, I mean the 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />, 20 5
hours is somewhat arbitrary but there is some basis for it.
6 Maybe the better approach is to take and not put 7
any hours down and go to more the course objectives that 8
Charlie had said and just say what the objectives are, but 9
then I would -- when someone comes to me with approval, all 10 they are going to say is " Dear NRC -- we will make sure that 11 the individual's training has met the following 12 objectives - "
And I won't be looking at any sort of hour 13 content is that what I am hearing that is where you would 14 like us to be?
r~%
I,)
15 MR. CAMERON:
That seems to be a core issue, so 16 let's follow that.
l 17 MS. HANEY:
Can I delete the hours now?
18
[ Laughter.)
19 MR. CAMERON:
Let's see what -- for example, 20 performance objectives -- the concept that Miriam brought up 21 may be a little bit different than what Chuck was saying. He 22 may still want to get into specific hours, but this is the 23 question, in terms of what the NRC should look for, should 24 there just be performance objectives or something broader 25 than specifying hours, or do we need the hours up there?
l (s)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
l L
268 l
I 1
Frans?
/"
.( N}
2 DR. WACKERS:
I think the whole discussion is kind 3
of confusing.
So again the goal is that people'are being 4
taught radiation safety and' handling of radioisotopes and I 5
think you have the content there and I think that is t
6 excellent.
7 What you want to know from a program is, and 8
actually as an aside there are two different situations. One 1
9 is that in the course of a training program there will be 10 two or one hour a week that there is a curriculum that will 11 run over a year or sometimes a two year period, and you want 12 to know, you want to say okay, how is this being taught, and 13 then you get two hours and you get to, well, who is 14 teaching, and I think that is where you really want to see O
(,/
15 the teaching curriculum of a program.
That is one.
i 16 Then you have a situation where people either are 17 not-in a program where that is being given or they go to a I
18 course like -- to Rose's course or another course and again 19 you want to see, well what is the curriculum of this course, 20 who is teaching it, what is being taugl.*., and obviously you 21 will get into the hours, but I think again the most 22 important thing is the content, who is teaching it, and from 23 that will follow how much time you spend there.
24 I think the confusing thing is if we try to force 25 everything in one content, every time we do that we say
[
ANN RILEY & ASSOCIATES, LTD.
\\-
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 1
.._. _ _.~ _..
269 y
'I well, it's different for a physician than for radiotherapy em V).
l 2
than for Radiation Safety Officer and I know why you like to l
l 3
do that but at the same-time I don't understand why you like 4
to do that because it's different.
5 MR. CAMERON:
Okay.
Chuck?
6
- MR. ROSE
I would like to clarify something just 7
to see if something has changed here that I have missed.
]
l 8
If someone puts in under.the proposed change, as 9
of last Friday, if someone does four months of training, 10-right, the majority of it certainly being practice hands-on I
11 experience in radiation safety, handling of radioisotopes, 12 right, and if they get that training and experience then 33 they will meet the criteria for the proposed 35.290, 14 35.292 -- because all of these things are less than that.
~
O
(,,/
15 If they have some experience with generators and the kits, 16 et cetera, 35.293, 35.390, 35.392 -- in other words the 17 requirement for imaging alone added into the two cases or 18 three cases required for radiation therapy for 19 endocrinology, et cetera, would allow someone with four 20 months of training plus three cases or six cases, depending 21 on which ones they wanted to also be allowed to do 22 therapeutically, would allow them to be an authorized user 23 for all of those things, like a radiologist or a nuclear i
~ hysician, which would allow them with their 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, not 24 p
25 40 -- now we are higher, but with the proposed 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
, - ~
i i;
g 270 l
1 that classroom then would be a classroom that would allow i
()
2 someone to be the Radiation Safety Officer not just for a 3
private office with a single imaging modality, but a private 4
office with a single imaging modality.with a generator with 5
kits and radiation therapy both of hyperthyroidism treatment 6
and thyroid carcinoma, et cetera, still with the same l
7 didactic and experience requirement with the exception of 8
either three cases or six cases, which are still prescribed 9
in the proposed regulation.
11 0 So let'a just not concentrate on the fact that 11 mysteriously out there there's a group of people that are 12 going to be this single use only RSO, right?
By the way, 13 that person could be them if you had a hospital that didn't 14 have a radiation therapy department, let's say with a cobalt
()
15 therapy machine.
This person could be the RSO for that 16 hospital just as well as they could be the RSO here.
17 In a sort of convoluted manner, I am agreeing with 18 him, right, not that I have to be that convoluted, but the 19 f act is he has aul excellent point here with regard to 20 training the Radiation Safety Officer.
21 We have this idealized idea of what is going to 22 happen out there.
I am just telling you what happens now.
23 I know people who are RSOs that were trained in single 24 imaging modalities and then they add on to that two cases of 25 this and three cases of that and four cases of that and l -(
)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I l
271
(
1
' pretty soon they are now licensed for everything and add m
l
)
2 three cases for therapy or five cases for this and five l
3 cases for that.
Their basic training still stays the same, 4
and so I do think that if we are going to have the 5
authorized user automatically be allowed to be an RSO, 6
right, then this training has to be adequate to be an RSO.
7 There's a solution here. We have changed 8
everything else in the last week, right? -- why not just 9
change that, being authorized user does not qualify you to 10 be an RSO.
11 You've got a $200 requirement for RSO.
If that 12 was good, keep it -- or change it like the other things that 13 have been changed in the last week.
That is just my humble 14 opinion.
(%.
x_)
15 MR. CAMERON:
And that was a clarification.
16 DR. MAHER:
Let me amplify on this.
I find it 17 ironic that the NRC's purview is radiation safety.
It's not 18 clinical use and the associated, you can't tell them apart, 19-clinical radiation safety protection of patient and my 20 staff, but it is the other things and here we put the 21 smallest amount of emphasis and basically don't change it to 22 be an RSO.
23 I think the legitimate way for NRC to regulate 24 this process is through the RSO and I think there ought to 25 be training standards-.
I mean I don't care if we have to l
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
. ~. - ~. _.
~
272 I
give an: exam orinot.
I mean that's up to you.
But I think 2
-we have to'have minimum training standards _for RSO because 3
RSO drives the radiation safety program, right down to the 4
doctoral level.
They ought to be and they are supposed to 5'
be independent, so I think if that training was adequate 6
that is really the true avenue which NRC ought to be 7
regulating this process.
8 Let the boards determine what radiation safety is 9
required for the clinical administration.
I mean after all 10' if they don't do that correct then they'll have lawsuits, 11 they'll minimize their own contact time because the doses j
12 will be too high,.and I think that is a self-regulating 13-process and obviously they have done a good job in that area 14 but I think the RSO is completely different situation.
N 15 MR. CAMERON:
Let me make sure that I -- there 16 seems to be two options that have been suggested here for 17 dealing with the RSO issue.
Of course,~ there is the third i
18L option which is to not specifically deal with it, but one 19 would be to not equate being an authorized user with being 20 an RSO and the second is I think Ed's point, that you need 21' to have more hours up here so that you can be assured that 22 if you are going to have an authorized user be an RSO that p
23 they are going to be qualified to be a Radiation Safety 24 Officer.
25 DR. MAHER:
Also I think the NRC's focus needs to j )
ANN RILEY:& ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
273 1
be the RSO side rather than the clinician's side, and we f( )
2 spent a lot of time with what the users will have to do, but 3
let's talk about what the RSO needs to know and to control.
4 MR. CAMERON:
Suntha?
5 DR. SUNTHARALINGAM:
Again, a clarification.
If 6
you are a board-certified radiation oncologist, can you be 7'
an RSO?
If you are a board-certified, American Board of 8
Radiology, American Board of Nuclear Medicine, a physician 9
board-certified, can you be an RSO?
10 MS. HANEY:
Currently yes, 11 MR. CAMERON:
Cathy?
Barry?
The answer is yes.
12 MS. HANEY:
Currently, yes.
13 DR. SUNTHARALINGAM:
Currently yes, but in the new 14 regulations?
15 MS. HANEY:
In the new regulation if that board 16 came in and asked for us to recognize them as if one of 17 their candidates had completed the board and we approved 18' that board for the RSO category as well as for one of the 19 user categories, yes.
20 DR. SUNTHARALINGAM:
I have been training 21 radiation oncologists for the last 30 years.
I have been 22 training medical physicists.
You will in no way achieve any 23 nurdaer of hours that you put on there in any part of the 24 didactic programs, because all radiation therapy medical 25 physics that we teach our residents are spread over one f()
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
274 1
year. Some residencies give it every year.
Some give it
,m
( )
2 alternate years.
Some may give it only once in their three 3
year training.
4 All of medical physics, radiation therapy and 5
physics, which includes brachytherpay and radiation safety, 6
you can stretch it if you try to give those type of lectures 7
in more than 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, lectures.
What they get is hands-on 8
training with every case that they do with the physicians, 9
whether it be brachytherapy, teletherapy, or they may come 10 and spend some time with a physicist, but putting down hours 11 and say they shall receive so many hours of didactic is 12 stretching because we in our whole physics program that we 13 teach over six months or eight months or whatever it is, two 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> a week -- it stretches but we stretch it out to 70-75
,(_j 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />, and of that maybe 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> might be related to 16 brachytherapy, maybe six hours may be related to radiation 17 safety and hazards.
18 But what we are saying is that you are -- and I 19 have always had this problem.
If somebody fails their 20 boards, a physician, they are going to take a job because 21 they can take the exam in the next year, but in between they 22 want to be a user, so now they have to satisfy a common NRC 23 requirement, which is all these hours and a preceptor just 24 signs off because truthfully there's no documentation in 25 their programs that'they are this many hours of didactic
-m i[
)
ANN RILEY & ASSOCIATES, LTD.
A' Court Reporters i
1025 Connecticut Avenue, NW, Suite 1014 l
Washington, D.C. 20036 (202) 842-0034 i
i l
l 275 l
1 teaching and lab, but if you get through your boards you are
,y (v) 2 okay.
3 That is the dilemma which we are in and what we 4
are saying is if you are a board-certified physician there 5
are small hospitals that will take a board-certified nuclear 1
6 medicine physician or a board-certified radiologist and put 7
them as the RSO.
8 MR. CAMERON:
Barry, do you want to comment on 9
that?
10 DR. SIEGEL:
No.
11 MR. CAMERON:
I saw you sort of agreeing.
- Okay, 12 no comment.
Chuck?
13 MR. ROSE:
I think that is exactly the reason that 14 we have to prescribe the hours, because -- and also the (G,)
15 reason that even if it is a board we have to look at exactly 16 what they are doing to see if they comply with the 17 regulations.
18 MR. CAMERON:
Suntha, do you agree with that?
i 19 DR. SUNTHARALINGAM:
No.
The reason being you are j
20 essentially changing the entire residency programs, but what 21 is the content of a residency program is established by the 22 graduate medical programs and they have their own review 23 boards that they are sent people and review and they meet A
24 4 aith the residents and they get input from the staff, they 25 get input from the physicists and then they give approval, n
D)
ANN RILEY & ASSOCIATES, LTD.
(
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
276 L
1 but in radiation oncology as an example there must be now 96 l()
2 programs of which only 15 or 20 may be large programs --
3 residency training programs.
Others are small programs.
4 MR. CAMERON:
Okay.
I want to -- I am sorry I 5
interrupted you, Chuck.
I just wanted -- I was confused 6,
about whether you guys were on the same side or opposite 7
sides of the issue.
8 MR. ROSE:
No.
We are sitting next to each other 9
but we are not on anywhere on the same side of the table, 10 but other than that -- the wall is here.
11 Again, you know, this is why the NRC has to 12.
prescribe specific criteria for people to follow regardless 13 of whether it is a board or whether it is an alternate route 14 or whatever you want to call it, because if you don't
/^\\
(_)
15 prescribe it and if you don't enforce it, it won't happen.
16 Now because of the fact that it hasn't happened in 17 the past, perhaps with his board or some other board or 18 maybe even a program, doesn't change the fact that there has 19 been a rule that the reason that board was acceptable was i
20 because of a certain amount of hours that they said were 21 prescribed and they were getting, and that hasn't happened, 22.
and so I think you have to have a rule, you have to have a 23 guide, you have to have a cookbook, you have to have a plan 24 by which people will follow that, right?
25 If they don't follow it, then they won't be t
-s,
- (
)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters i
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
1 l
4
I 277 1
acceptable because some people will feel that they have to Nj 2
follow it, just like a lot of people today get their 200 3-hours.
They do take their 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> and there is enough 4'
material to cover 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />, and other people are getting 5.
practically no hours, right, but they are equally licensed 6
Eus authorized users and they are equally licensed as 7
Radiation Safety Officers.
8 Now you can certainly argue, and I would have a 9
hard time defending it, the fact that there is no evidence 10 that one of these causes a greater public hazard than the 11 other, so if that's the case, right, then why do any training?
Why not simply license people to handle 12 13 radioactive materials?
14 A physician to prescribe would have to have a O(,/
15 medical license and would have to be licensed as a handler.
16 A person working outside the medical field would be -- or 17 even in the medical field who wasn't a physician would have 18 a license to handle, but of course they couldn't prescribe.
19 That doesn't take away the authority of the physician or 20 doesn't interfere with the practice of medicine, and in that 21 way we would get away from this concept of having the 22 physician be some kind of unique handling entity and other 23 people, be it the technologist, the pharmacist, whoever it 24 happens to be, would have to prove that they in turn have
.25 some experience here.
\\-
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 1
Washington, D.C. 20036 (202) 842-0034
278 1
That wouldn't create a problem with the
()\\
2 supervision issue because in the medical field the physician m
3 obviously supervises the medical care.
The physician is 4'
obviously the Captain of the ship and so that physician 5
obviously will still be in medical control, so just license 6
people as licensed radiation workers or -- by licensed I 7
mean as authorized users, right, or whatever term you want 8
to use, but not make it a criteria for just physicians.
i 9
MR. CAMERON:
Cathy, I think you have Option 3 10 right there.
What is it, Alternative 3?
l 11 MS. HANEY:
Yes, that is the authorized user.
'12 MR. CAMERON:
Okay.
Alan, did you want to make a 13 comment?
14 DR. MAURER:
I was just going to make a brief f%.
V 15 comment.
16 MR. CAMERON:
Fine.
i 17 DR. MAURER:
I agree with Chuck.
I think the only i
18
. reason the boards specify hours is because the NRC specified 19 heurs and I think you do need to set minimum training 20 criteria, whatever number we come up with.
I would not 21 eliminate the designation of required training hours.
22 MR. CAMERON:
So you would keep the hours --
23 DR. MAURER:
It gives people very firm guidelines 24 that they have to follow and if you don't have them thore, 25 it will become even -- I mean we know that there are places g).
ANN RILEY E ASSOCIATES, LTD.
is' Court Reporters 3025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
279 1
where they are not followed to the letter of the law today (g~s) 2 and training will become even more diluted.
3 MR. CAMERON:
Okay.
Thank you for that.
4 DR WACKERS:
I am getting confused.
I thought we j
5 had all agreed now to the 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />.
6 MS. HANEY:
Yes.
The 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> is for someone 7
that would only be using unit dosages, t
8 The example that is up here now would be someone 9
that was using a generator unit dosages would basically be 10 able to use the material however they wanted to use it, so i
11 that is why we have -- this'would be a four-month program, 12 and that program would be comprised of didactic training, 13 which would be the Number 2 up there, and then practical 14 training, which is your B, and those -- in the rule text at n(,)
15 least those two things combined would be a four month 16 program.
17 DR. WACKERS:
Okay.
The way I understood that 18 actually was that the minimal component is a need for sealed 19 dose would be 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />.
If you are dealing with generators 20 and all that, you need somewhat more and that you would have 21 at least 120, same 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> plus some more clinical 22 7ractical experience.
That is the way I interpret that.
23 MS. HANEY:
Right, but the difference would be the j
l 24 split on the 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />.
There are those that would argue if 25 we got down to a level of specificity and the hours for the l
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
280 1
didactic training that it would be the same whether you are 2
using unit dosages or non-unit dosages.
3 There are others that argue that those would be 4
different because if you are getting into using a generator 5
then there is whole other level of chemistry and handling j
6 experience that you need to have, so I could see where there 7
would be some difference between the unit' dose handler and 8
the one that could use anything that they wanted to.
9 MR. CAMERON:
Okay.
Thanks for asking about that 10 particular question.
11 Let's go to Phil and then to Suntha and then 12 Barry.
Go ahead, Phil.
13 DR. ALDERSON:
I think that you do need to have 14 some hours in the document somewhere.
I don't know the 15 rules but the question to me is whether the hours that are 16 stated in your rule need to be in the form of a regulation 17 or a guideline, and just take those words in the normal 18 context, not the NRC - Government context, but people need 19 direction.
People need to be led and I think you could lead 20 people effectively by proposing that -- providing some 21 guidelines, so these are the subjects and we think that the 22 guidelines would be about this amount of hours or you could 23' make it a regulation, but one way or the other I think you 24 have to state that because people I think need that, and I 25 don't think -- I don't know if Mr. Rose was just throwing a
)
ANN RIa* EY & ASSOCIATES, LTD.
s Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
I l
l 281 l
l 1
straw man at us there -- but I mean it is obvious that we i (A '
l l
2 couldn't just license everybody because the sophistication r/
3 that we are all aware of throughout our careers that are l
4 required to do and practice this safely just isn't there.
5 I mean whea people arrive at Columbia University, 6
they all'get a little lecture in the P 7 Safety Office 7
so they can have a little badge on ar be: a,.dged user.
I 8
mean those people aren't necessarily e in fact, they 9
-aren't able to perform at a sophisticated level, the level 10 we need our trainees to perform, so clearly that doesn't j
11 work, and I think you do need at least guidelines, but 12 whether they should be hard regulations or guidelines, on i
13 that I think we might want to think some more.
14 MR. CAMERON:
I put quotes up here around f~
15
" guidelines" and " rules" so that we know what I think your 16 concept is and it's not necessarily a term of art that we 17 are using there.
18 Let's take a couple more comments on this content 19 issue and then take a break and come back at 10:30 and try 20 to delve into the rest of this.
Suntha?
21 DR. SUNTHARALINGAM:
My comment again is regarding 22 the American Board of Radiology is the board that I believe 23 certifies the largest number of physicians who are using 24 radiation, and even in their programs unless it has changed 25 I don't see any hours cpecified in their guidelines for jh ANN RILEY & ASSOCIATES, LTD.
\\- '
Court Reporters 0.5 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i i
282 1
their training programs, for their residencies, because they
()
2 are guidelines, but 10-12 years ago I was also on the 3
committee preparing the guidelines for radiation oncology.
4 I think it essentially put down what and what should be 5
adequately covered.
They give a certain number of months in 6
terms of their clinical disciplines, but the statement was 7
that, you know, physics and instrumentation should be an 8
integral part of their training program.
9 So I think as long as each training program 10 reviews these materials with the trainees, that is what I 11 think the boards have been looking for.
12 MR. CAMERON:
Let me ask Cathy to put something --
13 can you put that -- the two options back up on the screen?
14 I think I have a question I think Sunt.ha needs to 15 address.
What I hear you saying is rely on the boards, 16 okay?
But there is also this so-called equivalent pathway 17 where NRC will approve a training program.
In that type of 18 situation you couldn't just rely on the boards.
19 DR. SUNTHARALINGAM:
Right, but even there one 20 then gives guidelines, not regulations.
l 21 MR. CAMERON:
So in that case we can use the 22 guidelines.
23 DR. SUNTHARALINGAM:
Guidelines.
l 24 MR. CAMERON:
All right.
Good.
David?
l 25 DR. COOPER:
I was just going to say that as was
{
l
(~g
'q J.'
Court Reporters ANN RILEY & ASSOCIATES, LTD.
4 1025 Connecticut-Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 l
L 283 l
1 discussed yesterday in my absence, our particular board exam A
'(_)
2 does not really focus at all on radiation protection.
We 3
would strongly favor the alternate pathway be maintained.
4 The other thing I wanted to say is that 5
endocrinologists who use a single isotope don't want to be 6
Radiation Safety Officers.
I mean that is not what we want 7
to'do.
We don't feel qualified to do that.
We don't feel 8
that.we want to be trained to do that, and all we want to do 9
is be able to handle one isotope to treat patients so that I 10 know that it may be difficult to deal with special 11
-interests, if you will, but I mean that is what I think our i
12 position t.ould be.
13 MR. CAMERON:
Okay.
I think that is coming across 14 clearly is that issue about how do you deal with specific b
A,/
15 cases like that.
Let's go to Barry and then Ed and then we m
16 will take a break.
Barry?
17 DR. SIEGEL:
David, first a question to you is I 18 know that is certainly true in a large hospital setting but 19 is that true in an office setting?
Are endocrinologists who 20 use I-131 in an office setting getting someone else to be 1
21 their RSOs or are they being the RSO named on their 22 licenses?
23 DR. COOPER:
I believe it is the latter.
In other 24 words, I believe that they open, handle, monitor the 25 radioactive materials -- that is, the I-131 -- in their e-(~"s)
ANN RILEY & AFCIATES, LTD.
l Court Re, eters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
t 284 1
offices.
(f 2
DR. SIEGEL:
Are they named as the RSO on the 3
license or do they have a consultant physicist named as the 4
RSO, because that is really part of the dilemma the working 5
group has been dealing with.
6 DR. COOPER:
I wish I could answer that.
I don't 7
know.
Most of the people that I work with are in hospitals.
i 8
DR. ROSS:
I am in private practice and I have 9
been doing this for about 15 years, and I am the RSO and I 10 feel that the training that I had, which is probably -- it's 11 been awhile ago but it's pretty comparable to what we are 12 talking about here and what is in the present regulations, 13 and I have never felt uncomfortable.
I do have a consulting 14 firm that is very helpful to me in maintaining my program.
)-
15 I wonder if I had had 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic 16 training 15 years ago if I would remember everything in that 17 as much as I remember Medieval History or stay fluent in 18 Spanish, so --
19 MR. CAMERON:
Well, we will have a quiz on the 20 Medieval History later on.
21
[ Laughter.]
22 MR. CAMERON:
Barry?
23 DR. SIEGEL:
Just a couple comments.
I do think 24 that specifying hours in the rule is a good idea bectase it does provide the lower level of the.bar and that has sort of 12 5 l
l I\\
ANN RILEY & ASSOCIATES, LTD.
k-Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036
.(202) 842-0034 l
_ I 285 1-been where the working -- we have gone back and forth but I N) 2 think the working group has felt that there has been some 3
need to set the lower level of the bar.
4 One thing though that has come up in the past that 5
came up many times at ACMUI is that the NRC with help of the 6
ACMUI or with help of a contractor should prepared course 7
syllabi that not only. lay out what the lecture series should 8
consist of but actually includes the material, and that that 9
becomes available as a NUREG available for purchase, and 10 then people can use that as the document from which they 11 trained.
12 It can have a suggested curriculum and then we 13 have got a very clearly defined set of guidelines that make 14 it clear what you need to learn.
15 One problem with doing that is that those tend to 16 be sort of static documents and if things do change, the 17 advantage of letting experienced medical educators figure 18 out where they need to be at any given moment is that they 19 have got flexibility.
If you lock it into a NUREG you lose 20 some of that flexibility, so that is another approach that i
21 hasn't come on the table.
22 Now a final point just before you break to really 23 upset the apple cart, we have talked about this a number of 24 times in the working group, and the notion has come up 25 directly or indirectly this morning that one alternative Q(~%
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
t 286 1
proposal is literally just to require training and
()
2 experience and documentation for the RSO, for the authorized 3
nuclear pharmacist and for the authorized medical physicist 4
because of the key role that those individuals play with 5
respect to various aspects of radiation safety and to not 6
require any training and experience for authorized users and 7
simply define in Part 35 that an authorized user is a 8
physician who is responsible for supervision and writing the 9
prescription and then leave it up to facilities to pick the 10 right person to do that job in order to make sure that they 11 comply with the various components of Part 35 and the 12 various components of Part 20.
13 It certainly solves all of at least the physician-14 related turf conundrums that are stuck with the discussion
)
15 in Part 35.
One might argue, and I think the radiation i
16 oncologists would argue that perhaps you wouldn't do that 17 for 35.400 and 35.600 uses, that you would leave that 18 essentially where it is because that is essentially the 19 proposed rule and the current rule are almost unchanged with 20 respect to 400 and 600 but that you could do that for 100, 21 200 and 300.
22 MR. CAMERON:
Okay.
That particular issue, since 23 it is an entirely different way to slice this, let's come 24 back to that for a few minutes at the end of the day and 25 talk about that.
i l
[
)
ANN RILEY & ASSOCIATES, LTD.
\\/
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
r l-287 i
1 The idea again, the suggestion that the ACMUI l (m,)
2 could do some work here on some sample programs, syllabi, i
3 whatever, there is a similar idea that came up yesterday and 4
I think Wally'had some ideas along those lines, but that's 5
also semething that perhaps for the NRC to think about not 6
perhaps in the -- obviously in the rule but perhaps in the 7
supplementary information or discussions with ACMUI, seeing i
8 if that would be a feasible idea and Ed, why don't you go 9
and we'll take a break.
I 10 DR. MAHER:
I endorse what you are saying.
I 11 think that is'the way the NRC ought to be regulating this i
12 process -- for the RSO.
I believe the boards do a good job 13 as far as clinicians and the amount of radiation safety, 14 that is integral to how you deal with your patients, they
\\
[d
\\
15 have done a good job.
I am not so sure I am willing to say 1
16 we put zero required training, but I think for the most part 17 the boards are doing a good job of -- with the amount of 18 training they have, but I don't think the boards are in the 19 business of growing RSOs, and I don't believe their I
20 curriculums are reflecting that, and that is my concern.
21 I think that is also a legitimate avenue for the 22 NRC to regulate is through the RSO not through the clinical 23 side.
It seems to me we have got this reversed.
24 We are trying to regulate this process through the l
25 clinical side.
I think that's a mistake.
l 3(y ANN RILEY & ASSOCIATES, LTD.
1 Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 1
r 280 1
MR. CAMERON:
Okay.
Let's be back around 10:30, a p.
-Q 2
little after.
3
[ Recess.]
4 MR. CAMERCN:
To just give you an agenda check, 5
again -- we are going to finish up on didactic.
There's two 6
other components that we haven't-talked about.
We're going 7
to take a look at the practical experience components.
We 8
have process and again process, there's this 2.A business of 9
the boards, recognition of boards, but then there is the
-10 equivalent pathway, resource implications and then this 11 issue that was brought up at the end before we broke about 12 training, authorized user, no training and experience 13 requirements.
We will try to hit that for a few minutes 14 before we break.
A (m_).
15 Do you want to hit it now?
16 DR. ALDERSON:
I want to hit it now.
17 MR. CAMERON:
Okay.
18 DR. ALDERSON:
I want to hit it now.
19 MR. CAMERON:
Hit it now.
20 DR. ALDERSON:
I would like to s:ay that I am and 21 the American Board of Radiology would be strongly opposed to 22 that idea and I think there are very good reasons why that 23 can't work.
I 24 I think that the utilization of these materials in l
25 clinical medicine requires immediate care.
It requires
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters l
1025 Connecticut Avenue, NW, Suite 1014
)
Washington, D.C. 20036
]
(202) 842-0034 j
L
'l L
I 289 1-physicians to deliver it.
It requires them to do it at all i
_2 hours of the day and night.
There are times when they have 3
to be primarily involved and in order to be primarily 4
involved they need to know all these various principles.
l 5
They need to be trained.
They need to be capable.
6 The chaos that would be. created in a 7
cost-restrained medical community if you had to build in a t
8 different group of people, multiple shifts of people, who 9
were the RSO dispensing these things and doing -- you know, 10 making these decisions at all hours of the day and night 11 would just be absurd.
1 12 I just -- I think it would be a truly chaotic 13 situation and I am strongly opposed to it.
i 14 MR. CAMERON:
Okay, well, I think we know how you 15 feel.
16 DR. ALDERSON:
Yes.
17
[ Laughter.]
18 MR CAMERON:
Let's give everybody else a chance 19 on this one and then we can -- it will be in the transcript j
20 for the Commission's perusal.
Let's go.
Ed?
21.
DR. MAHER:
All right.
I would not advocate 22 taking on the additional role of the RSO in making those 23 decisions.
That is not what the intent was.
Our intent or 24 at least my idea of this is that t.,r P ara giving training.
25 The radiation safety necessary for that training is ANN RILEY & ASSOCIATES, LTD.
j Court Reporters l
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l 290 1
integral.
You can't do the training unlcss you tell how to A
!-(,,)
2.
do it safely otherwise you all exceed your dose limits and 3
you would be out of work, so I really do feel that you can't 1
4 separate the safety and you will always be giving it if you 5
are giving a training program, but what I am advocating is 6
that the focus needn tc be through getting a qualified RSO 7
and a fully-trained RSO.
i 8
DR. ALDERSON:
The American Board of Radiology is I
9 not against qualified RSOs, nor am I.
What 1 am against is 10 the concept that physicians just wouldn't need to be 11 qualified in any way at all -- just remove all the bounds 12 and just they become some sort of low level -- not even a 13
. user.
They just become some sort of the low level 14 intermediary between the use of the material and the readout 15 of the product and I think that would be a major mistake.
)
16 MR. CAMERON:
Okay.
You are not suggesting that?
17 DR. MAHER:
No, no.
18 DR. ALDERSON:
But Dr. Siegel suggested that so 19 that is what I am speaking to.
20 DR. SIEGEL:
First of all, let me say that I threw 21 the idea out on the table because it has come up a number of 22 times in the working group.
It's come up directly and 23 indirectly here.
It came up as one of the alternatives that 24 was discussed at the pre-rule meetings, these public i
25 meetings that looked at the cross cutting issues, the idea J
i i
(m)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
291 1
that there would be no requirements related to the M.D.
or 2
that all you needed to be to be an authorized user was to be 3
an M.D. and those meetings rejected that notion quite 4
soundly.
5 I actually personally do not endorse this idea, 6
but I thought that it's come up enough that we need to hear 7
it one more time that people either think it's a great idea 1
8 or think it's a lousy idea.
9 MR. CAMERON:
Okay, so we have heard Phil on this.
10 We have heard from Ed that he wasn't suggesting that this be 11 adopted.
12 DR. MAURER:
Another comment.
I also think it is 13 a lousy idea and I have mentioned to a few people here we 14 are sort of in a schizophrenic mode when we deal with the 15 NRC.
16 As long as the NRC has regulations and 17 requirements and raises the issue of radiation safety 18 concerns with many agents we know don't hurt anybody but yet 19 require us to follow certain guidelines, then we need 20 well-informed, trained physician users who have been trained 21 adequately to meet the NRC guidelines and to serve the 22 public in terms of radiation protection.
23 If the NRC went away and all the regulations went 24 away and we decided that most of the drugs that we use z.re 25 totally harmless, then I think that approach with the ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 84 b34
^
292 1
Radiation Safety Officer -- but that is not the environment
()
2
-that we live in.
I think I agree with Phil.
3 It would be chaos to allow unlimited use of 4
radioactive materials throughout hospitals, throughout 5
office settings with the fact that we all need to live under 6
certain guidelines in terms of radiation safety and 7
protection that the NRC has put forth and most of us agree 8
with at some fundamental level, that there is an important 9
role in terms of radiation safety and protection for the 10 population, so as long as the NRC is here, as long as we 11 ~
agree that we do need to follow some practices, then we need 12 some limits and training for the people.
Otherwise there-13 would be chaos.
14 MR. CAMERON:
All right.
Peter?
(_,/
15 DR. MOORTON:
I would also like to go on record as 16 stating I am not for unlimited access to the 17 radiopharmaceuticals by unqualified or limited qualified 18 people.
Also, I would like to say that I do -- I like the 19 idea that Barry brought up about have a syllabus that the 20 NRC would send out as basic material for each group, so that 21 you have standardization overall.
22 You could correlate the ACGME or the AOA following 23 that basic document.
24 The other idea is that you could have a i
25-sub-specialty set for the RSO, which I also think is a good
(
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
l it 293 l
1 idea where if you have a dedicated person that is in charge I-w,i l
2 of everything that he has a booklet that the NRC could put V
3 out in a similar fashion that states his duties and job i
4 description and the fact that the RSO is the authorized user 5
in the instances of limited usage I think also applies, and 6
you could also have a fact sheet or a job description for 7
that person.
8 MR. CAMERON:
Okay, thank you very much, Peter.
I 9
am going to make sure that we don't forget that, and I'll 10 put'that up here.
11 Chuck, on the training and experience, authorized 12 user issue?
13 MR. ROSE:
Yes.
I just want to clarify something 14 here.
Only a physician can write a presc ription and so the (Q_,/
15 prescription for the procedure involving
'16 radiopharmaceuticals would be written by a physician exactly 17 the same way only a physician now can write a prescription 18 for other things.
19 The physician in the scenario we are sort of i
20 looking at here, or it's been thrown out, the physician is 1
21 not the one handling the radioisotopes.
The physician is 22 the one making the medical decision of the efficacy of the 23 procedure and the benefit and the risk of the procedure for 24 that patient, just like the physician does in any other 25 procedure that I would hope that they ordered on a patient, l
(n)
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 i
(202) 842-0034 j
p-
?
t 294 1
right?
rQ 1
(,f 2
That is different than handling the radioactive 3
materials.
The Radiation Safety Officer ultimately has the
)
4 responsibility in an institution or in a licensed facility 5
.for the radiation safety in that facility whether there is a j
6 radioisotope committee there or not.
The actual direction 7
comes through the Radiation Safety Officer.
8 This wouldn't take anything away from the i
9' physician's ability to order p,rocedures and if the physician 10 also was going to use the radioactive material, perhaps like 11 in some cases in endocrinology where they actually handle 12 the material, they may, then they certainly would need some 13 training and experience like other people would as would be l
14 deemed by the NRC and/or the Radiation Safety Officer, so k,)'
15 this doesn't detract in my opinion from the ability of the s
16 physician to control the facility, control the patient, 17 control the procedures done in that facility, be responsible 18 for quality control of the procedures done in that facility.
19 It has to do with who handles the radioactive material and 20 that radioactive material is usually not being handled --
j 21 the physician is not receiving the shipment, the physician 22-is not doing the leak testing, the wipe testing, the 23 exposure surveys, the contamination surveys, the wipe 24 surveys on the sealed sources, et cetera.
That is being 25 done by somebody else.
)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, P,.C. 20036 (202) 842-0034
~
.. ~ - - - ~
1 295 1
I~think that is where in this scenario the
()
.2
- emphasis.of the. training ought to be, rather than on the 3l
' physician.
The physician is still going to be the boss.
4' The1 physician is still going to control the health care 5
facility, control the script for prescription, the 6:
' interpretation, et cetera, and the Radiation Safety Officer 7
is the cae who directly is responsible either relatively 8
independently under the license or to the radiation safety 9
committee in an institution for the radiation safety in'that 10
~ institution.
11 MR. CAMERON:
Okay.
Let's get three quick 12 comments on it because we do have to move on here.
Peter?
13 DR. ROSS:
Can I ask a question of Chuck about his 14 comments?
15 MR. CAMERON':
Sure.
16 DR. ROSS:
How would you apply these principles to 17 an office like mine where I supervise the receipt of 18 isotopes and literally administer the I-131 myself?
19 MR. ROSE:
You would have to have training and 20 experience because those things that you are really licensed 21' for now under your scenario are really not the practice of 22-medicine.
The NRC is getting out of the practice of 23 medicine, so yes, you would have to have training and 24 experience and if you are going to be the Radiation Safety 25.
-Officer in your facility, which you said that you are, you ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
296 1
would have to have training and experience to be the 2
Radiation Safety Officer, but you wouldn't have to have 3
training and experience in the handling of radioisotopes to 4
be a physician.
You are already a physician and surgeon, 5
right?
6 So you are wearing several hats.
You are the 7
authorized user.
You are the, the way you described it, in 8
essence you are the worker, right? -- not that authorized 9
users don't work -- and you are the Radiation Safety 10 Officer, and you would have to have training and experience 11 to be the Radiation Safety Officer and to be the worker 12 doing it.
13 DR. ROSS:
Well, my comment would be that if the i
14 requirement -- I heard a figure like 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic l'\\
' V 15 training, which I refer to again as I did in my earlier 16 comment, to be an RSO for my facility I would then have to 17 hire basically a full-time RSO in order to continue my 1
18 program or for someone else coming in to start a program 19 similar to mine, which would effectively eliminate 20 endocrinologist completely -- their offices -- from this, j
21 and I reject that because of what I am sure Dr. Baskin said 22 yesterday -- we are the best qualified to administer 23 radiciodine and it is by far the most efficient, safest way 24 to do it in the office by the physician who knows the 25
. patient, and this would eliminate that practice.
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 I
i l
I 297 1-MR. ROSE:
I don't think it would, because -- I
()
2 agree with you, by the way, all right? -- but I don't think 3
it would eliminate it at all because to be the handler and 4
to be the Radiation Safety Officer might perhaps be the same 1
5 training requirement as you have now for endocrinology as 6
far as radiation safety is concerned.
7 It wouldn't necessarily be an increased training.
8 DR. ROSS:
As it has been for --
9 MR. ROSE:
As it has been, sure, for a long time, 10 because after all, it's good enough now, right?
There is no 11 evidence that it is not working.
12 DR. ROSS:
Correct.
l 13 MR. ROSE:
It just means that if you had a 1
14 colleague who wanted to order a radiopharmaceutical, that
'G
(_)
15 colleague could order a radiopharmaceutical but of course 16 you are.the one who is the authorized user or the worker and 17 the Radiation Safety Officer and you control it.
18 DR. ROSS:
Which is the way we do it in our 19 practice.
20 MR. ROSE:
Sure.
21 MR. CAMERON:
Okay.
I guess we are going to have 22 to -- I think we have gotten that out.
Let's go to Ed and 23 Wally and we will hear one comment from the audience here i
24-and then we really do have to move on and off of this issue.
25 DR. MAHER:
Yes.
I would like to kind of tell i
i O
l J-ANN RILEY & ASSOCIATES, LTD.
l Court P.eporters l
1025 Connecticut Avenue, NW, Suite 1014 Washington,
".C.
20036 i
(202) P J-0034 i
j
l i
i 298 j
1 people how at a nuclear power plant how you decide whether r~s.
)
g )
2
-radiation safety is adequace or not and that is all done 3
through the Radiation Protection Manager, RPM.
4 If he or she determines that we have workers or i
1 5
even if they are Senior Vice Presidents of the company that i
6 aren't following safety regulations they are not allowed to 7
access those areas.
That is that person's job.
8 In the medical community we have kind of reversed 1
9 that role.
We have kind of got the fox watching the chicken i
10 coop -- in many cases the physician who is directly i
11 financially responsible is doing the RSO responsibility, and i
12 I would say that this has worked in nuclear power -- as many 13 other areas of broad scope -- where the RSO determines who-i 14 is operating safely and can remove people who do not operate
(_,/
15 safety.
l 16 MR. CAMERON:
All right, hally.
j 17 1
DR. AHLUWALIA:
For the medical authorized user 18 with a limited scope license, I don't think it is a good 19 idea that they should go through the full-blown training of 20 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> so they should be RSO and they should have a 21 limited training to be the RSO for the limited scope.
I 22 underline the words " limited scope license" and " limited 27 scope training."
24 MR. CAMERON:
Okay.
That is another twist to 25_
that.
Rob -- and then we really have to go on.
(]s ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,.D.C. 20036 (202) 842-0034
p 299 1
MR. FORREST:
Just kind of a summary of everything O
( j 2
that was just said.
-3 I brought tq) the issue yesterday about the NRC 4
eliminating the authorized user because we have already I
5 established that the NRC is not in the business of l
6 determining clinical competency.
7 We are dealing with radiation safety issues here.
l 8
There's other mechanisms for determining who is clinically 9
competent to perform these things, and to address the 10 endocrinologists' concerns realistically if you had 11 Radiation Safety Officer requirements commensurate with the 12 level of use, and there could be specific training and 13 experience requirements for an endocrinologist who is only 14 handing I-131, that's certainly not up to the same level as 15 the broad scope, then you address all the problems and the 16 NRC gets out of the business of determining who at a 17 facility is clinically competent to be an authorized user 18 and the other mechanisms of the practice of medicine 19 determine that.
20 MR. CAMERON:
I'm glad we found a way to address i
21 that topic you brought up yesterday.
I think we have to i
22 move, unfortunately, to get to these other didactic 23 components, first of all, instructor qualifications, 24 criteria for evaluating students.
Are these the types of i
I 25 things that should be required in the NRC's recognition of a l
(')
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
300 1
board program or a separate program outside of the boards
()
2~
for training?
Is there anything else that needs to be under 3
didactic?
Do you agree or disagree with Cathy's straw man 4
on 1 and 3?
Alan.
Pardon me?
5 DR. WACKERS:
How.is that if you teach for five 6
years, you are better than -- I mean you are extremely 7
qualified by your training?
I think people should be 8
qualified, and I would -- usually, courses are taught by, in 9
our institution, it is a number of people, physicists, 10 radiopharmacists.
They have been doing it for many years, 11 but not necessarl_y if somebody comes in new out of this 12 training program he may more than qualified to teach.
13 DR. SIEGEL:
Yeah, but there is an "or" up there.
14 Bachelor's degree "or."
So if someone who doesn't have a 15 degree is doing the teaching, then it would have to be 16 someone who has been doing it for a long period of time.
A 17 physician, a Ph.D., someone with a master's degree would be 18 assumed to be automatically qualified.
19 MR. ROSE:
I think if you put bachelor's degree 20 there, you have got to say bachelor's degree in what.
I 21 mean that opens the whole can of worms.
They have got a 22 bachelor's degree in political science, you know, I mean --
23 MR CAMERON:
Okay.
I caught that comment.
I 24 caught that.
25 MR. ROSE:
I think that you could solve that I
jy Q
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 I
(202) 842-0034
i i
i 301 1
problem by simply authorizing or giving a certificate to, or
()
2 requiring a state license of, et cetera, just like you do 3
other teachers.
I mean why should this be different?
I 4
mean NRC doesn't do that, because it not in the educational 5
business, but to teach in a junior college, you have to have 6
a certificate or something that shows that you have had some 7
training and experience in that area.
Right.
8 MS. MILLER:
No, you don't.
9 MR. ROSE:
You could add to that -- I have got 10 some excitement on the other side of the room here.
You 11 could add to that the idea that under most licensees, they 12_
may not have the ability under their license to do this 13 teaching here because it involves perhaps the use of 1
14 radioactive materials which is not part of Part 35.
You
)
15 know, experiments in radioactive decay, half value layer, 16 half value thickness, et cetera, right.
And you now open up i
17 the idea of having another kind of license.
Do you have a l
18 license to use radioactive materials for teaching purposes?
j
\\
19 Right.
20 MR. CAMERON:
Thank you.
Let's go to Alan.
21 DR. MAURER:
I may need some clarification on this 22 point, but I would like to make a very strong stand against 23 the preceptor statement as it is in use right now.
Wearing 24 another hat, I think it was maybe three or four years ago, 25 as chairperson of a group that was called SCANM, Society of
[
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
1 302 1
Chiefs of Academic Nuclear Medicine, there was a meeting 2
with somebody from the NRC, and at that time there was 3
considerable discussion on the part of the training program 4
directors about the absence of significant -- of clear 5
documentation on the part of many preceptor statements.
6 Many people brought up the fact that in certain 7
departments there were pressures to complete preceptor 8
statements when trainees maybe had not cu.pletely filled the 9
letter of the law.
There was very poor documentation 10 required on preceptor statements.
11 I do not like the concept of the preceptor 12 statement as it currently exists.
There is no documentation 13 requirement that goes along with it.
When you look at other 14 programs that look at the levels of training, they are now 15 requesting copies of lecture schedules.
Attendance must be 16 kept at the lectures, that people attended the lectures.
17 And I guess the point of clarification that I need 18 is -- does this do away with the examination requirement?
l 19 In other words, if these hours or suggested guidelines for 20 training exist, are we doing away with a formal examination 21 to test the competency of the trainee.
22 The preceptor statement as it exists right now is 23 not working.
Many people are dissatisfied by the level of 24 documentation required, and there are many pressures for 1
1 25 preceptors in academic departments and other training b
ANN RILEY & ASSOCIATES, LTD.
V Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
=
l l
303 L
i i
1 institutions to complete preceptor statements when there has x_j
.2 perhaps not been complete --
t 3
MR. CAMERON:
Let me try to put some context on 4
this before we gec into a discussion of it.
In terms of 5
this third point the criteria, there may be a number of 6
ways to do that.
The one that Cathy has up there is 7
preceptor statement, there is-dissatisfaction with the use 8
of the preceptor statement that'could be fixed perhaps, or 9
you could just do away with it.
Other ways to evaluate i
10 students might be an exam, although that wouldn't be a i
11 requirement.
It would be one that -- to demonstrate i
12 approve-ability, so to speak.
13 So, how would you -- what are the other ways to do 14 number 3?
How can the preceptor be fixed?
Can it be fixed?
i t\\~ /
15 And I guess I would open that up.
Did the NRC -- Barry, do 16 you want to say anything abcut this before we get into 17 discussion?
i 18' DR. SIEGEL:
Alan, I mean I certainly am aware of 19 the problem you discussed, but ene of the reasons for the 20 problem was because the requirements were flawed, because i
21 the 200 hour0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> requirement was in excess of what well-versed 22 teachers thought was appropriate to teach the people for 23 this amount of material.
And by reducing the training and 24 experience numbers to something that experienced people 25 think is more reasonable, you have a far higher probability
)
-~
ANN RILEY & ASSOCIATES, LTD.
Court Reporters l
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i 304 1
that training programs will actually carry out what needs to 7s i
( )
2 be carried out.
]
3 The preceptor statement is going to be redesigned 4
in a way to require additional clear statement that the 5
training has occurred, and it would be a relatively easy i
6 step to -- relatively easy, I say, but Cathy may correct me l
7
-- to require some documentation that the training has 8
occurred.
I mean that is not something --
9 DR. MAURER:
My point is that it is not working in 10 the form that it is, and it would need significant 11 improvement.
12 DR. SIEGEL:
But it is not working because the 13 construct has been --
14 DR. MAURER:
- Well, 15 DR. SIEGEL:
Not because the people who are 16 training physicians really believe that they don't have to 17 train physicians.
18 DR. MAURER:
The problem is, of course, if you ask 19 for 200 and people say, well, we will give 80 or 100, and 20
.then you ask for 80, then they are goiry to end up giving 20 21 or 30, in reality.
So, you know, that is a problem, you 22 lower the bar and people slip a little bit lower rather than 23 jumping over it.
24 MR. CAMERON:
Okay.
I haven't heard someone say 25 throw the preceptor statement out entirely yet.
It could be f%
( ')
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 l
(202) 842-0034
305 1
fixed.
Let's go to Miriam and then Cathy, you can --
(O
/
j 2
MS. MILLER:
I just want to tell Chuck that I have 3
a master's degree as my highest graduate degree, and that is 4
all I had to snow when at I taught at Cornibia College.
I 5
needed no teaching certificate.
At George Washington 6
University, it wac the same thing.
I just had to prove that 7
I -- and when we site visit for accreditation for nuclear 8
medicine technology programs, we look at the instructors, we 9
look at either a bachelor's degree, in anything, because it 10 is a composite of liberal arts, whatever the degree is, plus 21 the fact that they have continuing education in the field 12-that they are teaching in.
13 MR. CAMERON:
Okay.
Thank you.
Thank you for 14 that clarification, Miriam.
15 Cathy, did you want to say something on the 16 preceptor issue?
17 MS. HANEY:
Right.
I wanted to say under number
'18 3, what I was looking for more was what would be NRC's 19 criteria for approving, not necessarily the boasd or the 20 training organization could go above and beyond this, but I 21 am looking at it from the standpoint of what is the minimum 22 baseline that NRC should accept when they are looking at 23 approving a training program.
24 MR. CAMERON:
In other words, they would have to 25-demonstrate that they had some mechanism for evaluating
[\\- )
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 L.,........
306 1
students' understanding of the material.
It wouldn't e
l 2
necessarily have to be a preceptor.
It wouldn't necessarily 3
have to be an exam, it could be class attendance.
Is that 4-right?
5 MS. HANEY:
Right.
And it really could be 6
nothing.
It could be just merely the person sat there for i
7 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> or whatever the magic number was.
You know, do I 8
need to evaluate the students' understanding of the 9
material, or can I just -- under the didactic training, or 10 do I just go strictly to the final sign-off by the preceptor 11 and say as long as the person has that, I am fine, I am 12 happy.
13 MR. CAMERON:
Okay.
Let's -- okay, you heard what 14 Cathy was looking for there.
Let's go to Mark and then over 15 to Peter.
Mark.
16 MR. RAYMOND:
I would enhance item 3 in a couple 17 of ways to address your concerns, Cathy.
One would be to 18 require that the preceptor actually indicate the number of 19 hours2.199074e-4 days <br />0.00528 hours <br />3.141534e-5 weeks <br />7.2295e-6 months <br /> and-sign-off in that way.
And, number 2, I would 20 request that the preceptor -- request that the student 21 demonstrate a passing grade on an examination.
I think that 22 any learning experience that is important in any way has an 23 examination associated with it to guarantee that the person 24 actually mastered the material.
Whether we are talking 25 about board certification, a college class in pathology, or f3 1O ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
r 307 1
7th grade math class, any serious educational endeavor
()
2 always has some sort of end of course exam associated with v
3 it, trd I would add that to item 3 as well.
4 MR. CAMERON:
Okay.
I tried to capture those up l
5 there, but I know Diane and you are keeping track.
Peter.
{
6 DR. MOORTON:
A couple of points.
In item 1, I
7 think a lot of the physics courses are taught by medical 8
physicists, and I don't think, the ones that I have come in i
9 contact don't have teaching certificates, so I wouldn't 10 require a teaching certificate.
And I am sure many of the 11 radiologists or nuclear medicine physicians don't have 12 teaching certificates and they are teaching their residents, 13 so I think that is not a valid request.
14 Under item 3, under the preceptor statement, most 15 residencies require that the residents maintain a log of 16 cases that they see.
I think an attendance record for the 17 physics lectures should be kept.
Most physics courses have 18 homework assignments, et cetera, you could keep track.
The 19 preceptor could state that they have satisfactorily 20 submitted their homework assignments, their attendance 21 requirements, and then have fulfilled the requirements of 22 the physics portion.
23 MR. CAMERON:
Okay.
Thank you.
Those are useful.
24 Useful suggestions, Peter.
Let's go to Wally and then 25 Frans.
]
A
(]
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters
)
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
308 1
DR. AHLUWALIA:
Basically, I think that the (p/
2 preceptor statement which is currently being used is very 3
satisfactory.
Preceptor -- as Peter has said, we all keep a 4
log, how many cases of brachytherapy, HDR and LDR, or 5
interstitial an individual has done, we go over the record.
6 The only requirement of the current preceptor statement is 7
the documentation of evaluation, that should be the 8
strongest point.
Some level of competency, some level of 9
passing grade is very important.
10 MR. CAMERON:
Okay.
Thank you, Wally.
And Frans.
11 DR. WACKERS:
Well, I am basically saying the same 12 thing.
We have our course and I think it is important that 13 the director or whoever is supervising will be the 14 preceptor, because there has been a lot of -- it has been e
1
\\/
15 unclear.
I have sometimes signed off as a preceptor because 16 they were doing the clinical experience, but I think it 17 should be cle : there is a person who is the -- it could be 18 the physicist who is teaching the course, and if there is 19 clinical experience, it should be signed off by another.
20 But I think one of the problems in the past, as 21 was mentioned, was the unreasonable requirements, but also a 22 lack of documentation.
I think at the present time all 23 residents and fellows know that they document everything 24 that they are doing in the present time, and that makes it 25 for the preceptor a lot simpler to really sign-off on that.
p)
(,
50H1 RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
309 1
MR. CAMERON:
Okay.
Thank you.
Cathy, Barry, any t.
,m.
-( )
2 questions to anybody on this?
3
[No response.]
4 MR. CAMERON:
All right.
Let's move along to the 5
second component, _ supervised practical experience.
You see 6
that Cathy has supervisor qualifications.
The environment, 7
skills mastered, and, again, I guess the criteria for j
)
8 evaluation, the same comment, I take it, would be -- that we 9
gave up here, would be applicable down there.
So, how about 10 comments on any of those, 1,
2 or 3?
I will give you time 11 to look at it, particularly the skills mastered.
Barry.
12 DR. SIEGEL:
I mean a log is -- a log type is the 13 way -- a document is the way to prove that that has been 14 accomplished.
What we do in our training program is we have O(_j 15 a couple of pages worth of things we call a group of 16 proficiencies that our residents need to complete during 17 their training, and it follows the general medical concept 18 of see one, do one, teach one, sort of, if you will, and it 19 says what they have to do, and they indicate what day they 20-observed it and the_ person who trained them initials that, 21 and then what day they actually did it under supervision, 22 and the person initials that, and then they go and do some 23 additional ones on themselves.
And there is a list of 50 or 24 60 things that we expect our nuclear medicine residents to 25 have done out in the clinical areas related to these kinds 1
.(%
ANN RILEY & ASSOCIATES, LTD.
/
Court Reporters l
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
m t
310 IJ
.offthings that they have to' accomplish.
So a log with
()
,'2 documentation.
3 MR. CAMERON:
Okay.
That goes to the criteria in
~4-terms of the 50 or 60 things that you want them to master.
5 Would they basically fall into these categories, do you
-6
.think, or could we have additional?
7 DR. SIEGEL:
Our log, we have them -- we have 8
' add.itional things,-but they are also, they are clinical 9
related things rather than these things.
But all of those j
- 10 things are included.
11 MR. CAMERON:
All right.
Phil and then Chuck.
12_
DR. ALDERSON:
Just a minor point about the 13 qualifications for the supervisors.
It says must be an 14, authorized user.for that type of use.
There are some
()
15
. jurisdictions,.and this gets into localities, I am going to 16 suggest that we broaden that language a bit.
Where -- and 17 this, in. fact, happened at our place some years ago, for a 18'
.while.
For a while, there-was a local practice that 19
, suggested that there would only be one authorized user in 20 the group.
And so we had a large nuclear medicine group l
21~
with-three or four, you know, very well qualified 22 physicians, but only.one person was the authorized user.
l l
23 And if you really stuck with that and stayed strong with it, H
24 then the. rest of those people might be precluded from being
.25 supervisors or instructors, is that not true?
You are ANN-RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 1(202) 842-0034 l
~
311 1
shaking your head.
(m,)
2 MS. HANEY:
I guess under what you described, yes, i
3 thef would be precluded from being that.
But I guess I 4
wasn't really aware of the situation where you were 5
precluded from having more than one authorized user.
6
-DR. ALDERSON:
Well, subsequently, you know, there 7
have been some changes in the local approach in New York 8
City and we have been able to get everyone now approved.
9 But the fact that we experienced that makes me think that i
10 maybe somewhere else in, you know, the nation, this same 11 sort of local problem might be.
And I would just suggest 12 you just broaden that language a little bit to give 13 consideration of that.
14 MS. HANEY:
Okay.
,-m ks 15 MR. CAMERON:
So how would you broaden it?
16 DR. ALDERSON:
Well, or equivalent.
Just or 17 equivalent.
18 DR. SIEGEL:
I don't teach my residents how to 19 elude a generator.
My radiopharmacist teaches my residents l
20 how to elude a generator.
I don't teach my residents how to 21 work a gamma camera.
My supervisory technologist teaches my l
22 residents-how to work a gamma camera.
But I, until 23 recently, as the program director, was responsible for l
24 ensuring that the proper delegations were in place to make 25 sure that the residents were taught.
I didn't physically do l
l'( j)
\\
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
312 1
it all myself, and I suspect that the rest of us who run
[b -
2 training programs don't do it all ourselves.
3 MR. ROSE:
So that doesn't -- but, again, some broadening of the language would help you in that program.
4 5
DR. SIEGEL:
We need to broaden that.
6 HMR. CAMERON:
Okay.
We have got that.
Or 7
equivalent.
Let's go to Chuck and then Alan.
Chuck.
8 MR. ROSE:
Okay.
I think we can solve that one 9
quite easily, and what you said still goes on, right.
Very 10 common, right.
11 DR. ALDERSON:
It is common, 12 MR. ROSE:
And that means that the person who is 13 the authorized user doesn't have a clue, may not even 14 hardly, in some cases, even recognize the person they are m
15 doing the authorized -- the preceptorship for, it just means 16 that they were there.
Right.
You could say that the 17
~ supervisor of qualifications is even an authorized user, or 18 under the supervision of an authorized user, then-we would 19 say work for an authorized user, which is a given, because 20 at any licensed facility, you have got an authorized user, 21 right, and that allows them to delegate it, right, and that 22 could be right there at the top.
23 Yeah, that's enough for right now.
I will come i
i 24 back later.
25 MR. CAMF90N:
All right.
Alan.
.[
)
ANN RILEY & ASSOCIATES, LTD.
\\d Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington,.D.C. 20036 (202) 842-0034
l 313 1
DR. MAURER:
I was going to say that is, in my 2
experience, also not an uncommon situation.
I sort of like 3
the term program director, because that does give ultimate 4-responsibility for the program overall.
And, as Barry l
5 mentioned, most program directors have responsibility to 6
make sure that all the components of the program fall into
{
l 7
place, so I like that term program director.
8 And for the qualifications of the program 9
director, if the NRC is going to give -- deem status to the i
10 board, in many teaching places, that is going to be somebody 11:
who is board certified in any of the organizations that you 12 approve, or may have those additional may be an authorized 13 user.
14 DR. SIEGEL:
The only problem with the term l
15 program director and, I agree, it works for programs, is 16 that it may not work for the practical em erience that an 17 endocrinologist will get if he joins Peter practice, and he 18 went to the two -- he went to the course, the 80 hour9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> 19 course, now he has got to get his handling experience doing 20 these kinds of tasks as wea.1 as administering the patients 21 and Peter doesn't really qualify as a program director, but 22 he does qualify as an authorized user who can directly 23 supervise this activity 24 DR. MAURER:
Yeah, all I am saying is that there 25
.are multiple components here, so that there is an integrated l
ANN RILEY & ASSOCIATES, LTD.
Court Reporters l
1025 Connecticut Avenue, IW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
l 314 j
-1 program and the direator or supervisor has to be responsible
(
2 that all those componants are in there.
Ultimately, one 3
person at the top has to supervise.
And some people like l
4..
the chief tech or a radiopharmacist may provide some of the 5
training in one place, or it may be the nuclear medicine t
6 technologist who gives the hands-on experience in terms of 7
using a survey meter or something else.
8 MR. CAMERON:
The point is that the term 9
supervisor should be explained, basically.
10 DR. MAURER:
Yes.
Or given the concept of the --
11 MR. ROSE:
In endocrinology, as well as in 12 cardiology, I would say the majority of the time the 13 training program director is not an authorized user.
Okay.
14 Because it is a training program in endocrinology or it is a
/^()
15 training program in cardiology.
But that training program
)
16 director, the person who is charge of the fellowship or the l
17 residency program is not an authorized user.
18.
There are also radiology programs where the 19 training program director of the radiology residency program j
l 20 is not an authorized user.
So I think -- I agree with what 21 yoa are saying, but -
22 DR. MAURER:
Right.
The program director not to 23 the clinical program, but for the NRC training program.
24 DR. COOPER:
It is just an ambiguous term.
So I 25 would also be in favor of not using that term, program ni]
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i
Washington, D.C. 20036 (202) 842-0034 i
315 i
i director.
77 i
i
)
2 MR. CAMERON:
All right.
%_/
3 MR. ROSE:
I think in all cases if you say it is l
l 4
an authorized user or under the supervision of an authorized 5
user, obviously, it has to be under the supervision of an 6
authorized user, and then that takes care of it.
7 MR. CAMERON:
Okay.
Alan, you are not necessarily 8
tied to the use of: program director, you just think that the 9
concept should be explained, what we mean by supervision.
10 MR. MAURER:
Correct.
11 MR. CAMERON:
All right.
Barry, do you have your 12 card up for any -- okay.
I guess, any last comments before 13 we move on to process and resources.
Skills mastered, does 14 this look pretty basically correct to people?
And, Chuck, I
(
\\
\\_)
15 will turn to you for a first comment.
16 MR. ROSE:
Back on preceptorship statement again.
l 17 Now the preceptor statement is a preceptor who is signing a 18 statement about experience, right, not a didactic, but a 19 program experience.
20 MR. CAMERON:
That's right.
21 MR. ROSE:
My first question is I am not -- 1 am 22 still unclear as to whether the NRC is now saying you really 23 want these people to get 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br /> of handling experience.
24 Barry is shaking his head.
But that is basically what the 25 proposed regulation says.
I would also argue that we have l
i ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
4 316 1
to have control over this aspect of the preceptorship
,(,)
2 statement, just like we did with the didactic training.
3 One of these societies or organizations 4
represented here at the table published something a few 5
years ago, about a year-and-a-half ago, of the list of 6
locations where people could go to get preceptorships, and 7
those preceptorships, in one case, were $5,000 a week.
All 8
right.
And that doesn't mean that they didn't get the 9
experience, but I think that that gives at least the 10 appearance, right, the preceptorships for clinical -- not 11 clinical -- preceptorships for experience, right, might in 12 some cases be for sale.
And not that it has ever happened, 13 of course, but 14 DR. SIEGEL:
Why isn't education for sale?
I mean f\\
\\m /
15 I am not saying that that is the best way.
But I mean you 16 go to a university, don't you buy that experience at a l
17 university?
18 MR. ROSE:
Yeah.
19 DR. SIEGEL:
They don't give it away.
20 MR. ROSE:
Good point.
In this case the $5,000 21 was a university.
22 DR. SIEGEL:
And you don't give it away.
23 MR. ROSE:
Absolutely.
Good point.
Good point.
24 Okay.
I just think that we need to do some work on the 25 documentation of this, and I think Barry has a comment on p
/
ANN RILEY & ASSOCIATES, LTD.
'~#
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
l 317 1
what goes into these 600 hours0.00694 days <br />0.167 hours <br />9.920635e-4 weeks <br />2.283e-4 months <br />, or I would like to have
(%
Q 2
Barry make a comment on that.
I mean we know the skills 3
that are to be mastered.
Does that mean we are supposed to 4
spend four months ordering, receiving, calibrating, l
5 calculating, using administrative control and using 6
procedures to contain spills and administering doses?
7 MR. CAMERON:
Barry, answer to that?
Cathy?
8 DR. SIEGEL:
The working group's answer, at least 9
an oi last Friday, would have been that the training for l
10 unit dosage, for imaging and localization studies is 11 specified :in the straw document at the moment as 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> 12 didactic, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> handling.
13 For this expanded use that allows the use of 14 generators and, presumably, allows a broader range of 15 imaging and localization uses than would be encountered just L
16 in the unit dose environment, that at certainly a minimum, 17 the didactic and the handling experience would be no less 18 than the amount that occurs in the unit dose training and 19 experience requirement, but that the total duration of time 20 doesn't mean the individual will spend all that time doing 21 this handling, but rather that the didactic and the handling 22 experience will occur within the construct of a four month 23 integrated, clinical training program because of the belief 24 that the best way to Get the broad experience is within a 25 clinical training program, even though the NRC's focus is on i
l ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
.~
318 1
the radiation safety aspects of the training.
-(G.)
'2 So, in a way, for the broader use of specified 3
N-35-292, what the NRC is saying is that it is acknowledging 4
the arguments that it is not possible to. completely divorce 5
radiation safety training from clinical experience, even 6
though it is not specifically asking for the individual to 1
7 document their clinical training as part of what it choose 8
to review.
Is that clear?
9 MR. ROSE:
Yes.
Thank you.
10 DR. WACKERS: -Why did you not say that?
That was i
11 my confusion as well.
So it is 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> and 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> for i
l 12 the sealed services, that is what it is.
For the unsealed 13 services, that all has to take place in a clinical 14 experience of four months.
If you say it that way, then you b
\\s
15 know for sure that they have minimal training as well.
16 MR. CAMERON:
So that, we could provide more of an 17 explanation on that.
18 DR. WACKERS:
Yeah.
19 MR. CAMERON:
Okay.
20 DR. WACKERS:
That is the minimal component, but i
21 on top of that is the richer clinical experience.
22 MS. HANEY:
Right.
When you say sealed and 23 unsealed, just to match the rule language, it is unit dose 24 and non-unit dose, just for the record.
25 DR. SIEGEL:
And Sam just corrected me.
In the
.(-)
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
l 319 l
1 unit dosage, we didn't break it out.
We called it 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> n
()
2 of training in the.last Friday construct.
Our thinking is 3
that it is-probably 80 plus 40, but we have decided not to 4
specify it to give programs some flexibility in terms of 5
shaping the training based on their own estimates of what 6
their trainees need.
It could be broken out again, and it 7
could be specified in 292 if people really thought it needed 8
to be specified.
9 MR. CAMERON:
Okay.
Thanks, Sam, for bringing 10 that_up.
And, Rich, did you -- you have some comments.
11 MR. FEJKA:
Well, under the skills mastered, 12 ordering, receiving, I guess I was going to mention l
13 something about quality control, but as I thought more about 14 that, that becomes a pharmacy type issue whic' indirectly
(_-)
15 deals with radiation safety, but I believe in the past there 16 has always been this idea of separating what is really NRC 17 required radiation safety issues, as compared to something 18 that might be a medical issue.
19 MR. CAMERON:
Okay.
I think that we have success 20 on that one.
Go ahead.
21 DR. SIEGEL:
There is actually something missing 22 from here.
When Cathy did this morning, she left out the 23 item related to eluding generators, preparing kits, checking 24 for molybdenum,-doing quality control.
25 MR. CAMERON:
So that is the quality control
. (s)
ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
. ~..
I i
i 320 1
issue.
Good.
Thank you.
All right.
Great.
/
(,)/
2 And we are -- I do want to try to get you out of l
3 here on time, because I know that some of you may have, you 4
know, travel plans.
So what I would like to do is to move 5
into'the process resource issue and Cathy has some -- she i
6 tried'to come up with'what the possible NRC resources would 7
be on this for the board approval, and tnen for the 8
equivalent pathway.
But do we need to talk about -- I think 9
we need to talk about the process.
10 In other words, well, at least about the ACGME/AOA
'll issue before we get into resources.
And I am little bit --
12 I was going to ask Barry or Cathy to explain what that 13 particular option is.
Is it the idea that we would only 14 accept ACGME/AOA approved programs, or would there still be i
O
\\ssl 15 an' equivalent pathway of non-ACGME?
I just want to have 16 everybody clear.
17 DR. SIEGEL:
The latter is correct.
18 MR. CAMERON:
Okay.
19 DR. SIEGEL:
It would still be in an alternative 20 pathway, but the advantage of having the program be ACGMB 21 approved or AOA approved is that there is a very well 22 established quality assurance mechanism for the quality of 23 the training, and that the training actually occurs.
We 24' know that site visiting occurs of those programs on a 25 periodic basis.
They have to reapply ever five years l
[
f^-
( j)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
321 1
usually at the outside to have their application stay O
(,/
2 active.
So there is'a mechanism in place.
3 MR. CAMERON:
How many -- I am guess I am -- how 4
many possible paths are there?
In other words, board 5
approval and/or ACGME.
In other words, could these -- the 6
equivalent pathway could either -- could still be an ACGME, 7
et cetera, approved or a non.
It.is not just applicable to 8
board approval.
9 DR. SIEGEL:
The reason I suggested to Cathy this l
10 morning, that in terms of resource implications, that what 11 the board says its candidates will have done and what 12 trainees will have done in an ACGME approved program, if the 13 focus is on training, is identical.
Someone who completes a 14 radiology residency will have had the training in an ACGME
,(,J N
15 approved program whether or not that individual chooses to 16 go on and take the board exam.
17 So the reason for combining them is that the 18 American Board of Radiology could, if it chose, working with 19 the Residency Review Committee for Radiology, submit a 20 single package of information that for diagnostic radiology 1
21 residencies, nuclear radiology residencies, and radiation 22 oncology residencies, contains all the information the NRC i
23 needs to say that the training programs contain what they 24 need to, and that individuals who are baard certified will 25 have the training that they need to satisfy the NRC.
That ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
-~ -
322 1
could be one package.
The review of that package could be
( j}
r~
)
2 very -- the amount of resources required to review it would 3
be much less than having to review many, many, many 4
individual training programs.
5 MR. CAMERON:
Okay.
Thanks for that i
6 clarification.
And let's go -- let's go to Alan first for 7
comments, and then'we will go Frans, Phil.
8 DR. MAURER:
There is this and/or component of 9
ACGME.
My understanding is that ABMS boards in this country 10 are all a part -- undergo ACGME approval through the RRC.
11 So that the first category would be existing boards who use 12 the ACGME approval and recertification.
So I would take out 13 and/or.
I am not -- I am not sure I understand that, 14 because there are new boards coming along which are not in
~
(s N) 15 the ACGME review process.
So I think you have to -- I would i
16 just say ABMS boards with current ACGME approved programs, 17 and then move on to the next category, non-ACGME/AOA.
18 Because the difference is one has an established 19 mechanism for site visits, recertification, and 20 documentation.
Those are the ABMS boards that participate 21 in the ACGME process.
22 DR. SIEGEL:
But they are not automatically 23 approved.
24 DR. MAURER:
No, but they would have to be.
25 DR. SIEGEL:
The NRC still wants to approve --
i I
ANN RILEY & ASSOCIATES, LTD.
Court Reporters i
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
- _ = _ -
323 1
DR. MAURER:
Absolutely.
()
2 DR. SIEGEL:
-- even the well-established ABMS
'3
' boards and the AQA boards.
4 DR. MAURER:
Right.
I recognize that.
But --
5 DR. SIEGEL:
And new boards could apply.
6 DR. MAURER:
But not I wouldn't call it a board 7
if it is not -- not an ACGME approved board, if it doesn't 8
participate in the ABMS with the existing on-site 9
recertification program.
10 DR. SIEGEL:
We can fix the language, I understand 11 you concern.
12 DR. MAURER:
Do you follow?
13 DR. SIEGEL:
Yeah.
14 MR. CAMERON:
Okay.
So the American Board of 15 Medical Specialties -- do you understand that, Cathy?
16 DR. MAURER:
What the NRC is buying there is the 17 fact that there is an existing accreditation process, and 11 8 that they don't want to worry about that, because it exists.
19 I mean I --
20 DR. SIEGEL:
Correct.
21 MR. CAMERON:
So does everybody -- do people 22 understand that, or care to understand that?
Maybe that is 23 the --
24 DR. MAURER:
To clarify, current ABMS boards 25 undergo this five year maximal recertification process, 1
i)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014' r
Washington, D.C. 20036 (202) 842-0034
324 1
which is very well established.
There are on-site visits.
()
2 The trainees are -- I mean, as Barry is saying --
3 DR. SIEGEL:
It is not the board that undergoes 4
that, it is the training program.
5 DR. MAURER:
The training program.
6' DR. SIEGEL:
It is the ACGME approved program.
7 DR. MAURER:
But tPose training programs meet the 8
requirements of the --
9 DR. SIEGEL:
Really, the way this construct is 10 designed, a board is approved really because its trainees 11 undergo ACGME approved training.
The board goes a step 12 further, though.
It says not only have you had to complete 13 the training, but you had to have proved your clinical 14 competence by taking our board examination.
15 DR. MAURER:
We think we understand what we are 16 saying actually.
17 DR. SIEGEL:
We are clear.
I know how to --
18 DR. WACKERS:
You may understand what you are 19 saying, but it is very confusing.
So I think you should 20 take the board approval off.
You want to look at programs.
21 You want to see whether the programs are ACGME approved.
22 That is all, you would make it much simpler.
23 DR. SIEGEL:
No, but the reason for leaving boards 24 is the reason that Cathy said yesterday, because someone who 25 has got the board certificate in their hand, the only thing A
)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
325 1
they need to do --
()
2 DR. WACKERS:
But is the alternative pathway --
3 DR. SIEGEL:
The only thing they need to do to 4
become an authorized user is to show that certificate.
No i
5 license amendment is required.
NRC simply needs to be 6
notified within 30 days.
7-DR. WACKERS:
You are talking about number 2, 8
right?
9 MR. CAMERON:
No, this isn't the so-called 10 equivalent pathway.
In other words, you could be --
11 DR. SIEGEL:
The equivalent pathway is the third 12 thing down there.
13 MR. CAMERON:
You could be board -- see, this sort 14 of confuses -- the way it is laid out, it is sort of 15 confusing.
Okay.
I mean you could be board -- 2.A-is board i
16 certification.
-17 DR. WACKERS:
Right.
18 MR. CAMERON:
Okay.
That board doesn't 19 necessarily have to be an American Board of Medical 20 Specialties approved board.
Right.
21 DR. SIEGEL:
Say that again.
22 MR. CAMERON:
It doesn't need to be an ABMS 23 approved board under 2.A.
24 DR. MAURER:
No, my understanding is that that is.
25 2.B then --
ANN RILEY & ASSOCIATES, LTD.
~
\\-
Court Reporters o,25 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
326 1
DR. SIEGEL:
No.
l (q s
)
2 DR. WACKERS:
It was to be approved by the NRC.
3 DR. SIEGEL:
It is approved by the NRC.
So the 4
board of the Royal College of Physicians of Canada is 5
currently accepted because they came to the NRC and said 6
here is what our training and experience consists of and 7
here is what we test in currently, under the current rule.
8 They could come in under this rule and say we meet the 9
requirements.
10 The certification board of Nuclear Cardiology 11 could come in and say people who have passed our test meet 12 these requirements.
We don't admit people to the test 13 unless they have had this amount of training, we get 14 documentation that they have had this training, and, 15 therefore, the NRC would be required to accept that 16 documentation.
17 DR. MAURER:
My understanding, the difference --
18 Cathy was concerned about the amount of resources that the 19 NRC would have to apply to approve these boards.
And what I 20 was saying, under the ABMS, ACGME, it saves them a 21 tremendous amount of work, because we are assuming that the 22 on-site visiting and documentation.
So I would make that a 23 separate category.
24 DR. SIEGEL:
Okay.
25 DR. MAURER:
Because the other one is going to l ()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
327 t
1 involve additional NRC resources to make sure that the new
()
- 2
-- maybe my misunderstanding, that the new boards can 3.
document to the NRC adequately the adequacy of their on-site 4
inspection and review process.
Do you understand the 5
difference?
6 MR. CAMERON:
Is this correct, there would be 7
three categories, at least in terms of resource 8
implications?
There would be ABMS boards, non-ABMS boards, 9
and.non-boards, right?
10 DR. SIEGEL:
That is correct.
11 MR. CAMERON:
Okay.
12 DR. SIEGEL:
Well, but then there is two 13 categories under non-boards.
14 MR. CAMERON:
Yeah.
Well, good, what are they?
k 15 DR. SIEGEL:
It would be ACGME and AOA approved m
16 programs, so I was going to --
17 MR. CAMERON:
Okay.
Good.
And non.
All right.
18 DR. MAURER:
A clarification.
Under non-boards --
19 DR. COOPER:
Only that last thing you wrote down 20 would be sort of the alternate pathway, right?
21 MR. CAMERON:
This is the so-called equivalent 22 pathway.
23 DR. COOPER:
But even the first thing you wrote 24 down under that really isn't anything unusual.
The person
- 25 went through a program that is, you know, registered as a
()
l ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
i l
328 1
program.
It is just -- they didn't take their boards.
That
()
2 is all I was saying.
The last thing you wrote down would 3
really be the only equivalent program, right?
l
'4 MR. CAMERON:
This thing?
I 5
DR. COOPER:
Yeah.
6 MS. HANEY:
Look.and see if we have got it right 7
on our stuff.
8 DR.'SIEGEL:
So, Alan, in terms of your tiered i
9 structure, the NRC's job would be very minimal under 1.
At 10 least based on what we currently think, it would be minimal 11 under 3, too, because --
12 DR. MAURER:
I am not sure I understand 3 because 13 how can it be --
14 DR. SIEGEL:
Because what we are saying is the r\\
k) 15 individual has completed their training within an ACGME m
16 approved training program.
The radiation safety is a 17 component of that program.
18 DR. MAURER:
But that is the question I raised l
19 yesterday in terms of additional resources.
I think that is 20 a little bit more resource-intensive, because now you are 21 including a minimum integrated program which should require 22 some similar on-site verification.
23 DR. SIEGEL:
Well, yes and no.
If giving 120 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of radiation safety training is an ACGME requirement 25 for a particular type of program listed in the green book, (nj ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
329 1
and approved by the Residency Review Committee, why does the i
/^%
j
(
)
2 NRC need to look at it?
j 3
DR. MAURER:
Okay.
Fine.
But what I said earlier i
4 this morning is that many of these new ones, for example, 5
endocrinology, they would have to.go to the RRC --
6 DR. SIEGEL:
They have to change --
7 DR. MAURER:
They are going to have to change 8'
their exam requirements to meet that.
9 DR. SIEGEL:
Exactly.
10 DR. MAURER:
And if that existed, I think --
11 DR. SIEGEL:
Or they come in under the latter, 12 which is more resource intensive.
13 DR. COOPER:
That's right.
That's what we are 14 saying, because we are not -- all endocrinologists don't
\\s,/
15 want to do this.
16 DR. SIEGEL:
Well, you didn't hear yesterday, you 17 could offer it as an elective in programs.
18 DR. COOPER:
Could.
Sure, but i
19 DR. SIEGEL:
And you could even still send them to 20 the course but have it listed as an elective in the green i
21 book.
22 DR. COOPER:
But it wouldn't be a necessary part 23 of endocrine training is all I am saying.
24 MR. CAMERON:
For purposes of -- and we are going 25-to go to Suntha next.
For purposes of checking whether the
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
.. = _ _
330 1
-- what the resource requirements are, are we -- are these r()\\
2 basically the options that we are working on?
And people 3
understand these and you can tell me which ones are 4
equivalent.
Which ones of these are equivalent pathways?
5' The equivalent pathway, as opposed to the board.
The last
]
6
-- these two could be variations on the equivalent pathway?
7 MS. HANEY:
Yes.
8 MR. CAMERON:
All right.
Okay.
Suntha.
9 DR. SUNTHARALINGAM:
Again, a question regarding 10 non-physician individuals.
Let's take medical physicists.
j 11 There are very few training programs, most of them come 1
12 through years of experience, and I think, if 1 understand 13 correctly, that they would be the Board of Radiology or the 14 Board of Medical Physics, the requirement is that their
. _)
15 clinical experience be obtained under the guidance of a 16.
board certified physicist.
So there are no structured 17 programs pertaining -- there are very few, I would say.
18 Now, it is coming on, but in the past they have been 19 non-existent.
So most of the requirements to take board 20 exams has been years of clinical experience, and there are 21 certain minimum requirements.
So I guess that will then 22 fall under -- and-approving such a thing will go under your 23 category 4?
24 MS. HANEY:
Right.
And the purpose of this merely 25 is for me to get some resource estimates to go back to the l
/~
(N)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l
Washington, D.C.
20036 l~
(202) 842-0034
331 1
Commission with, with the final rule of saying this is what n(,)
2 it will cost to implement this rule from the licensee's side 3
as well as from NRC's side.
So I would see the RSOs, the 4
medica 1' physicists, and probably the pharmacist all coming 5
in under that estimate of the last item that'is on the 6
screen, the fourth category.
7 MR. CAMERON:
Okay.
Thank you.
Frans, do you 8
have a question?
9 DR. WACKERS:
Well, let me just -- so that we 10 really know we talk about the same thing.
So the resource 11-implications, or the least resource implication would be 12 that somebody comes and has -- is board certified in 13 radiology.
That, there is no problem there.
14 DR. SIEGEL:
The resource is not for reviewing an 15 individual now, the resource is for deciding that someone 16 who is certified by the American Board of Radiology has 17 fulfilled the requirements, because the NRC doesn't need to j
18 do much other than receive some documentation from the ABR 19 that says people who are board certified by us have had this 20 training and, moreover, we have gone a step further, we have 21 tested in it.
22 DR. WACKERS:
Right.
23 DR. SIEGEL:
Even though you didn't require it, we 24 have done that.
Okay.
25 DR. WACKERS:
That is the least, that is if we l
-s Q
ANN RILEY & ASSOCIATES, LTD.
Court Reporters
(
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 4
(202) 842-0034 l
-._~
332 i
1 check mark 3.
The second is -- so, hopefully, so the non --
(
)-
2 at the present time non-ABMS, boards like the certification 3
exam in nuclear cardiology and hopefully approved, that 4
also, you have to do some work to look at these boards, but r
5 it will be less-work in the future.
t 6
Then you get into more work, and that is ACGME.
7 So people who are -- for example, a cardiologist who takes 8
the physics course in our department, the Yale Department of 9
Radiology, that is an ACGME approved radiology program.
Is 10 that -- you have to look at that, and you say, okay, he took 11 this in the Department of Radiology, the program is 12 approved, and, therefore --
i 13 DR. SIEGEL:
But that training is not an ACGME 14 approved component of the training program in which that O(_)
15 person is really enrolled.
The fact that you sent that j
l 16 person over to radiology to get the basic science training 17 doesn't solve the problem.
What you need to do is get that 18 training required in the green book as part of cardiology 19 training.
Then you can come in under that.
20 DR. WACKERS:
That is -- but that will not happen 21 in the next decade probably.
22 MR. CAMERON:
Yeah, but there are still, even 23.
though that might not happen, it is still --
24 DR. SIEGEL:
It is only 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />.
25 DR. WACKERS:
So why would you -- okay.
Now you ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 l
333 I
1 are getting down in the alternative pathway.
So why would
,m()
2 the NRC then accept that somebody goes and takes a course 3
somewhere, but would not accept that somebody goes to an 4
accredited program and takes a year of the physics?
5 DR. SIEGEL:
Well, they will accept that.
They 6
just won't accept it under the lower resource-intensive 7
route.
They won't cal it an ACGME route.
8 If your training is a Yale, you want to tell --
9 submit your program and say our-cardiology trainees go 10 through the following program, NRC will look at that program 11 and say that is an acceptable training program.
If it meets 12-the requirements that are laid out, you can then proceed to 13 train people.
14 DR. WACKERS:
Okay.
/_T s
kI
=15 DR. SIEGEL:
Certify that they had the training, 16 they will be acceptable to the NRC.
17 DR. WACKERS:
It will take more work to do that.
18 DR. SIEGEL:
But it takes more work because it 19 doesn't-have the purview of the established reviewing 20 mechanisms to stamp it.
21 DR. WACKERS:
Okay.
Good, I think we are talking 22 about the same.
23 DR. SIEGEL:
Okay.
24 DR. WACKERS:
Okay.
And then most intensive will 25 be indeed those programs that exist, like the courses that d
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
i l
t, 334 l
1 exist.
So, okay.
\\
l 2
MR. CAMERON:
I maan that is what -- that is what L
l 3
posited here.
It is not necessarily true, and I guess, 4
Alan, do you -- you raised the point yesterday about the 5
approval of the training program route rather than the 6
examination route might be pretty resource-intensive.
Do 7
you want to comment, do you want to flesh that out now?
8 DR. MAURER:
Well, I was a little unclear with the 9
alternative pathways.
Say it is a problem for cardiology to 10 get the ACGME to include -- I don't think it is a problem, I 11 mean if they want to do, and the same thing for --
12 DR. SIEGEL:
I don't think 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> added to the 13 green book is going to be a problem.
14 DR. MAURER:
And then their RRCs would have to do l
15 the site inspections and make sure that it was happening.
16 As an alternate, I thought the alternate pathway would be 17 whatever that new board is.
It is not the certifying l
18 council or it is not -- a new board could exist for 19 cardiology where they would take the requirement for on-site 20 training and do'that internally, in other words, through the 21
-- I don't know who would do it.
It would be the equivalent 22 of.an ACGME review process where you would establish centers l
23 that are certified, that you would inspect them on, you l
l 24 know, a periodic basis.
You would visit.
And then you l
25 would come to the NRC and say-we are doing this, so we are l
/'N i
ANN RILEY & ASSOCIATES, LTD.
Court Reporters i
1025 Connecticut Avenue, NW, Suite 1014 l
Washington, D.C. 20036 (202) 842-0034 t
~.
335 1
non-ACGME, quote, board which seeks deemed status, just like
()'
2 the other boards, you are just not using the ACGME approach.
3 But you would have to do the legwork rather than the NRC.
4 And'what I was saying yesterday was if they didn't do that, that would be very labor-intensive for the NRC to approve 5
6 these non-ACGME new boards.
Do you follow what I am saying?
7 MR. CAMERON:
Now, there's not only the non-ACGME 8
new boards, there's the organizations that aren't boards 9
that offer the training, such as Chuck's organization, and 10 that would be the most -- it is at least suggested that that 11 would be the most resource-intensive.
And, Chuck, can you 12 give us your view on the issue of what you think the 13 resource implications might be for the NRC?
14 MR. ROSE:
Well, I would say that we would really (s,)
15 fit in both the -- I guess it is the fifth route there, if I 16 picked one of those as a route, in other words, the 17 non-ACGME, and we also fit in the ACGME because our program 18 is currently used by ACGME programs as a component of their
{
?. 9 program and it would have to be listed in the green book.
i 20 DR. SIEGEL:
It is not specified anywhere, it is j
21 not in the special requirements anywhere.
22 MR. ROSE:
Right.
It would have to be in the l
23 green book.
But for the resources for approval, in our 24 case, I think that the resources you have there probably are 25 very adequate seeing we have already been through four
(- s)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters s
1025 Connecticut Avenue, NW, Suite 1014 1
Washington, D.C. 20036 (202) 842-0034
336 1
on-site reviews, approvals, documentation, et cetera,
()
2 through other accreditation and licensing organizations, l
3 because, again, we do give college credit, and we are a 4
licensed institution, et cetera.
5 So if this is the NRC resources involved, which 6
apparently it is, I really can't judge how efficiently the 7
NRC would do it, but from our standpoint, it would be no 8
problem to comply with anything they wanted because we have 9
already done it and have to da it on an annual and biannual 10 basis anyway, so I don't see it as a problem.
11 MR. CAMERON:
All right.
Okay.
Thank you.
And 12 then is green book, right?
13 MR. ROSE:
Yeah.
14 MR. CAMERON:
All right.
O)
(,
15 MR. ROSE:
Unless they change the color.
s 16 MR. CAMERON:
Peter, and then Suntha.
17 DR. MOORTON:
I have a question on the first item 18 there, the ABMS, AOA board approval.
If a person has -- the 19 training program meets the requirements and there is a test 20 given, the next tests are ABMS, AOA, non -- or they are 21 non-approved, but by the fact that it is a board, they are 22 also giving a test.
Now, when you get to the next category 23
-- when you get to the next category, the component, or the i
24 alternate pathway, there's no test.
25 MR. CAMERON:
Well, there's no test required under ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036
)
(202) 842-0034
F
]
l 337
]
1 this approach generally.
(m,)
l 2
DR. SIEGEL:
The boards are doing more than is
(
3 required, but that is not necessarily bad.
1 4
MR. ROSE:
It doesn't mean that the NRC couldn't 5
require a test for non-ACGME board type programs, both ACGME
.6 and non-ACGME.
i They could -- the NRC could always make that 7
one of the requirements.
8 MR. CAMERON:
But I don't think that is included 9
as this approach.
I mean the point is, is that if the -- if
{
10 in one of these categories we wanted to use a test, then 11 that is fine with the NRC.
They could go beyond the 12 training program _ requirements.
But the NRC, unless there is i
13 a variation for, for example, this would be approach number 14 3, is that for these people, we are going to look at -- we (3
\\~sI 15 are going to require an examination.
16 MR. ROSE:
Sure.
17 MR. CAMERON:
But we have not done that.
The NRC 18 has not done'that.
That is not part of this approach.
19 MR. ROSE:
But it doesn't preclude them from doing 20 it, to establish a program.
21 MR. CAMERON:
Right.
If you wanted to change the 22 approach, if we thought that would be a good idea, or if the 23 NRC did.
Suntha.
24 DR. SUNTHARALINGAM:
No, I am coming back, coming 25 down later on, board approval.
.q
' ()
ANN RILE'l & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
338 1
MR. CAMERON:
All right.
And we need to -- yeah,
)
2 we get to there, but let's go to David and then Frans.
3 DR. COOPER:
I think that you ought to require an 4
examinaticn of any non --
5
{ Laughter.]
6 DR. COOPER:
No.
No, no, no, no.
That you ought 7
to require a non-ACGME alternate pathway mechanism to B
require an examination of some sort, not that you have to 9-approve the exam or look at it, or anything.
I am just 10 saying part of the certification process for certifying a 11 non-ACGME, AOA program would be that that program has some 12 sort of exam.
I mean it just seems to me that is the one 13 sort of minimum thing that you can use to assure yourself.
14 MR. CAMERON:
Okay.
Let's put that f\\
\\~ I 15 recommendation, make sure everybody knows that there is 16 another variation suggested here, which is that instead of 17 these two approaches, one approach is examination-focused, 18 this approach is training program-focused, that there be a 19 third variation which would have an examination associated 20 with this.
21 Now, I don't know what the ratic' ele for pro and 22 con would be to do that.
We haven't discussed that, but 23 apparently, does this make -- it makes sense to some of you 24 anyway.
Alan, do you want to supplement?
25 DR. MAURER:
Yeah, that was the first question I i
1 I
l l
(s)
ANN RILEY & ASSOCIATES, LTD.
i Court Reporters i
1025 Connecticut Avriue, NW, Suite 1014 Washington, D.C.
20036 l
(202) 842-0034
t 339 l
1 wasn't clear on.
The preceptor statement is a part of it, (n,)
2
'but I didn't -- I still think for whatever approval of 3
non-ACGME or new boards, those people have to come to you 4
and say we have some form cf examination as a part of 5
evaluation of the trainees.
I still think --
6 MR. CAMERON:
So you are going back to the 7
content.
8 DR. MAURER:
Oh, absolutely.
I didn't know we 9
threw that out.
10 MR. CAMERON:
All right.
11 DR. MAURER:
I though t1
-- it was not an NRC 12 exam.
I think we threw out the NRC exam.
But I still 13 think, and we had hours of discussion from educators 14 yesterday, and people who are experienced in training, and
\\_/
15 said it is not enough to just say you give the training, but j
16 you do need to exam the candidates.
17
- 4R. CAMERON:
I think we had better be clear about 18 the fact that the first approach yesterday, the 1 --
19 approach number 1, okay, was based on the fact that the --
'20 that there would be -- that the NRC would require an exam, 21 and that we would approve the examination provider or the 22 board in terms of that exam.
We took a straw poll at the 23 end of yesterday to see how many people thought that that 24 approach, which is in the proposed rule, whether that was 25 preferred to the second approach that we are discussing l
l ANN RILEY & ASSOCIATES, LTD.
l Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C, 20036 (202) 842-0034
340 1
today, where we would just look at that training program, (3
1
_j 2
not whether they had an exam or not.
i 3
DR. MAURER:
And I think I I said I was 4
confused at the end of yesterday.
I still think the 5
examination process, it is not going -- and I thought the 6
' difference-was the NRC was going to administer or supervise 7
the exam.
I still think whatever pathways exist, it is 8
incumbent upon the training programs to have some form of i
9 examination in that process that they offer to the NRC and i
10 say, this is a component of cur training program, we trained 11 the candidates and then we examined that.
And that program 12 would not be acceptable to the NRC unless it had an 13 examination process.
14 MR. CAMERON:
Let me try to use --
7 l
15 DR. MAURER:
I thought maybe we can go around the s-i 16 table and just agree on that, or disagree.
17 DR. SIEGEL:
Or disagree.
18 MR. CAMERON:
Yeah, let me just go to one chart 19 here just to -- we were looking at contents of approval of 20 the training program.
One component of that was the 21 criteria for evaluating students' understanding.
We talked 22 about -- Cathy had a preceptor statement and we talked about 23 how better documentation, et cetera, et cetera.
One other 24 way to do that, obviously, is through an exam.
25 Now, if the NRC accepted that, that wouldn't l
- (p)
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
[-
~l 341 l
1 necessarily mean that we were back in Approach 1 in terms of
()
2 an examination focus.
3 MS. HANEY:
That's right.
l l'
4 MR. CAMERON:
That's right.
So that may meet with l
l 5
your --
I 1
6 DR. MAURER:
Yeah, I will put it very strongly.
I
)
7 think there must be an examination process at the end of the I
i 8
training.
I don't think the NRC should be doing the 9
examination, which is what I thought was the gist of the 1
\\
major part of_the discussion yesterday, but that a program 10 11 should not be acceptable unless it does include an 12 examination process.
13 MR. CAMERON:
Okay.
Let's go to David for a 14 comment.
(3
- 1. (_,/
15 DR. COOPER:
The reason I even brought this up is 16 imply in terms of the resource utilization aspects of your 17
-- of what we were talking about.
I thought it would use 18 less resources if you could be sure that the certifying 19 organization had an exam, that you would feel more 20 comfortable with that.
And you had -- it would require less 21 work on your part, that's all.
22 MS. HANEY:
But I think the issue really is, if i
23 you;tell me you have an exam, do I stop there?
Or do I want 24 to know how many questions you have on the exam, what is l
25' your bank of questions, who grades the questions, where do 1
1
)
ANN RILEY & ASSOCIATES, LTD.
i Court Reporters i
1025 Connecticut Avenue, NW, Suite 1014 l
Washington, D.C.
20036 (202) 842-0034 i
342 1
I 1
.the questions come from, what is the confidentiality?
(O) 2 That's where the labor-intensiveness --
1 3
DR. COOPER:
No, you don't want to know that at 4
all.
l 5
MS. HANEY:
But then people would offer, if all l
6 you told me_is we have an exam, then we are really not doing 7
anything and why even look for it.
8 DR. COOPER:
Because we will tell you.that if l
9 people don't pass that exam, we will not certify them.
10 MS. HANEY:
But 11 DR. SIEGEL:
That's certification.
I mean a fair 12 amount of other physician training is an apprenticeship.
13 Would you agree with that?
14 DR. COOPER:
I-am just talking about the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />
('N (s l 15 of didactics now, for -- that is what I am referring to, not 16 the practical aspects of things.
17 MR. CAMERON:
Okay.
Frans, do you have -- do you 18 want to shed some light on this?
19 DR. WACKERS:
Well, I think it is really -- it 20 makes sense to have a course and then so you will evaluate 21 what you are doing.
And I think that is probably what you 22 want, some evaluation.
But in the cardiology training, we 23 are being taught things that are far more dangerous and we 24 can kill people, and we have no exam while we are in 25 training.
Even you can finish your cardiology training, and
(
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 u
l l
343 1
there is no exam at the end.
You can take the boards, but
/~N l (,)
2 there is no -- we are doing, and I experienced that, it is I
3 an apprenticeship and you -- that's the way we work.
You 4
were talking about, we all agree that safety is --
5 DR. COOPER:
I was referring to the didactics, the 6
didactics, that's all I am talking about, the didactic part 1
7 of it.
8 DR. WACKERS:
Well, yes, I know what you are 1
9 talking about, I think it make sense to have some 10 evaluation, but don't make it a mandatory part of it.
11 MR. CAMERON:
Okay.
I want to go Phil and Chuck.
12 But I guess the key is, can you include exams as part of 13 that component without dragging us into everything that we 14 thought we were going to get into under Approach 1?
\\~-
15 MR. ALDERSON:
That was the essence of my comment.
16 I mean we need to remember what we talked about yesterday 17 for hours, and all the myriad, myriad of complications, and 18 that if you enter into exam here, I don't see how you -- I J
19 don't think it is inconsistent with the approach on the 20 board, but if you enter into it, you have to know something 21 about the quality of the examination, and suddenly you are 22 opening up that whole box of yesterday.
23 MR. CAMERON:
Yeah.
24 MR. ALDERSON:
And I think people have to realize 25 that without us redebating it here today, and there are a O\\
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
344 1
lot of liabilities there.
There are very successful federal
(
)
2 programs, like MQSA, as we discussed yesterday, that are i
l 3
high risk, very successful, don't have anything to do with 4
an examination.
So I would consider those liabilities.
5 MR. CAMERON:
I think that just to sum up from 6
yesterday, I think that the straw poll that we did indicated 7
that, at least if people knew what we were voting on, which 8
may be in some considerable doubt, but that people, that the 9
majority of people preferred or thought that this was the 10 better approach, this being the training focus.
11 So the question is, is that -- how do you factor 12 in an exam component into the didactic as a method of 13 evaluating the students' understanding without dragging us i
14 into all of the Appendix A material and all of the seven or
/~N.
1 15 eight points that Mark pointed out that is connected to the 16 testing?
17 Do we need to -- are we really hopelessly confused 18 here?
19 DR. MAURER:
Well, one way to get around it is to 20 have as a guideline that if you are going to approve new 21 boards, that it would be recommended that there might be 22 some examination process.
And I think most people, if they 23 are going to go to the bother --
24 DR. SIEGEL:
You keep saying board.
It is 25.
acknowledged that a board is going to have an exam.
l l (~))
(_,
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034 1
l L
345 l
l 1
DR. MAURER:
I'm sorry, the non --
(~N l A )
2 DR. SIEGEL:
But this is a training programs.
3 DR. MAURER:
These are the alternate pathways.
4 DR. SIEGEL:
And remember, there's --
5 DR. MAURER:
Maybe the simple way -- I mean 6
anybody who is a teacher is going to want to test their 7
students, I would think.
8 DR. SIEGEL:
Boards is a convenience.
It is a 9
convenient
'10 DR. MAURER:
And it might make the application to 11 the NRC stronger if they provide you with some documentation 12 of that.
13 MR. CAMERON:
Okay Let's go to Chuck, he has had 14 his card up for a while.
15 MR. ROSE:
Well, I think I can end this i
16 conversation because, you know, we are basically talking 17 about our program.
Right.
And whether the NRC requires us 18 to give an exam or not, we are going to give an exam, and we 19 are not going to change that, and we train more authorized 20 users than all of the boarded programs and the ACGME 21 programs combined on an annual basis.
So we will not give 22 up an examination of our students.
We will make it pass or 23 fail, like we have been doing in the past.
In other words, 24 we will not lower our standards.
If the NRC does not l
25 require an exam, we will not change it.
Getting through our l
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 t
2 84 b3 l
l
i 346 1
program will still require an examination, as I had
()
2 mentioned to you folks yesterday, with that number of 3
_ uestions, all those hours to complete, et cetera, so it q
i 4
won't change.
5 MR. CAMERON:
All right.
Thank you, Chuck.
Mark.
6 MR. RAYMOND:
Yes.
I think that any training 7
program or course can offer an examination without opening 8
up that whole box that we went into yesterday.
9 MR. CAMERON:
So you think that is porsible.
All 10 right.
11 MR. RAYMOND:
The ACGME requires that residency 12 programs evaluate their students, yet they don't go into 13 great detail and do a serious psychometric evaluation of
)
14 those particular instruments and require validity -- and so ss.
15 on and so forth.
They just want to know that the students 16 are being evaluated.
And having that --
17 DR. SIEGEL:
But it doesn't always include an 18 exam.
19 MR. RAYMOND:
No, it doesn't.
20 DR. SIEGEL:
I mean most residency training, the 21 faculty evaluates how the residents are doing as their 22-clinical skills evolve.
23 MR. RAYMOND:
I was using that by way of analogy.
24 That is, they require an evaluation without going into 25 detailed psychometric studies of the validity of the i-O
'y,g ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
347 1
evaluation instrument, and I don't think you have to do that
)
2 here with an end of the course exam.
You can have an exam 2
without requiring days and days, or months or months of 1 4 documentation to support it.
5 MR. CAMERON:
Okay.
I think that that is a useful 6
statement.
7 Dl-SIEGEL:
Just a question.
I agree with that, 8
but I am still concerned that Alan thinks that if I just 9
give an exam in my training program to my candidate, to my 10 residents, after they complete their hours of didactic 11 training, that that is not good enough.
12 DR. MAURER:
Well, I would be the first one to 13 admit, I think what we do with medicine is not ideal.
We 14 all know medical students who get through medical school, l
A k-15 get into residency, and are not good performers, and because 16 there is no mechanism to do that, often get through.
I 17 would just say that in approving any alternate pathway, I 18 think the program that is coming in the alternate should 19
-require some form of examination, and you would like to know 20 that they sat through the lectures and they learned the 1
21 naterial in terms of basic radiation safety, and I think 22 examination is an important part of it.
23 DR. SIEGEL:
We agree.
24 MR. CAMERON:
Yeah, I think that we understand l
25 that and that that needs to be -- there needs to be some i
i ANN RILEY & ASSOCIF.TES, LTD.
Court Reporters 1025 Ccnnecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 I
(202) 842-0034 i
_. ~
.m r
348
[
1 comfort given.
We are almost out of time, and I guess Cathy
()
2 has one other' issue that I can't admit that I understand 3
this last number of approvals business.
Cathy, would you 4
just tee that up?
5 MS. HANEY:
Right.
I was just trying to get an 6
idea of the number of approvals that I would need to give 1
7 under the first pathway, that would be if I was going to j
8 approve boards.
So looking at the current rule, and not 9
getting into any of the English, British fellows, or into 1
10 the Canadian approvals, if I was going to approve ABR, would 11 I probably be looking at three different categories of 1
12 approval?
13 DR. SIEGEL:
Diagnostic radiology, nuclear 14 radiology, and radiation oncology.
p_
15 MR. ALDERSON:
That's right.
Three, yes, s-16 DR. SUNTHARALINGAM:
We are doing both 17 radiological --
18 MR. CAMERON:
Could you speak into the mike, 19 Suntha?
20 MS. HANEY:
Well, that's what I have.
Yeah, I 21 have -- I didn't go to the physics, and maybe if we can do 22 the physicians first and then --
23 DR. SUNTHARALINGAM:
ABR.
.24 MS. HANEY:
Okay.
So if I add the plus-one here.
j 25 MR. CAMERON:
Any other additions or deletions to ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
349 1
this particular component?
,rh Q
2 DR. SUNTHARALINGAM:
American Board of Medical 3
Physics, ABMP.
4 MR. CAMERON:
There were some suggestions made 5
yesterday on specific boards.
6 MS. HANEY:
That would be one, right.
7 DR. SUNTHARALINGAM:
Well, it is in radiation 8
oncology physics, but also we have medical health physics.
9 MS. HANEY:
Okay.
10 DR. SUNTHARALINGAM:
ABHP for the RSO portion.
12 MR. CAMERON:
Did you get that ABHP.
12 MS. HANEY:
Just one, right?
13 MR. CAMERON:
And Peter.
14 DR. AHLUWALIA:
American Board of Science and O
'(/
15 Nuclear Medicine, ABSNM.
16 MR. CAMERON:
Now, Rich, what is it?
We are going 17 to have to be a little bit systematic here.
Go ahead, Rich, 18 and then we will go to Peter.
19 MR. FEJKA:
Board of Pharmaceutical Specialties, 20 BPS, in nuclear pharmacy.
21 MR. CAMERON:
Okay.
Peter.
22 DR. MOORTON:
And under AOBR, what were the two
.23 that you had in there?
24 DR. SIEGEL:
Diagnostic radiology and radiation 25 oncology.
You don't give straight radiology anymore, do j (]3 f
. ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l
Washington, D.C. 20036 (202) 842-0034 i
~.... _ _ _... _.
r l
l l
350 1
you?
f 2
( j DR. MOORTON:
We do have --
3 DR. SIEGEL:
You have candidates from the past.
4 DR. MOORTON:
We still have candidates in the past 5
that are practicing under radiology that are doing radiation 6
therapy.
7 DR. SIEGEL:
But they would be grandfathered if 8
they are board certified.
You no longer have any training 9
programs in radiology, correct?
)
10 DR. MOORTON:
Correct.
11 DR. SIEGEL:
Okay.
So you wouldn't need to apply 12 that someone new, having completed a training program, needs 13 to come in under this route, because you don't have the 14 programs anymore, so it is two.
(_/
15 MR. CAMERON:
Any --
16 MS. HANEY:
You would apply, okay.
17 DR. WACKERS:
CBNC.
18 MS. HANEY:
Let me put you under this list.
19 MR. CAMERON:
And what doec that -- what is that 20 acronym for everybody else?
21 DR. WACKERS:
Certification Board of Nuclear 22 Cardiology.
23 MR. CAMERON:
All right.
Wally, did you have any i
24 others?
25 DR. AHLUWALIA:
Yes, the top, ABR, p'us-one, f)
Ig ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
=
351 t
1 instead of one, should be two.
One is medical nuclear i 'q
_j physics and the second is therapeutic medial physics.
There 2
3 are-two subspecialties.
4 MR. CAMERON:
Okay.
You got that, Cathy?
5 MS. HANEY:
Got it.
6 MR. CAMERON:
Any other additions to this list?
7
[. o response.]
N 8
MR. CAMERON:
- Okay, 9
MS. HANEY:
Okay.
And then the next question 10 would be, I was looking at the ACGME programs.
If I was 11 going to approve those programs, those are the only four 12 categories.
And then for the AOA, there would only be tie i
13 three categories I would be looking for approvals.
14 MR. CAMERON:
Okay.
Rich.
(/)
15 MR. FEJKA:
I think APS, it should -- or Board of s_
16 Pharmaceutical Specialties, BPS.
J 17 SPEAKER:
BPS instead of APS.
18 MS. HANEY:
Okay.
That's good.
19 MR. CAMERON:
Well, that was pretty good.
Do 20 that.
21 DR. WACKERS:
Can I just make one comment about 22 the resource organization?
I am not sure that you really 23 have to do site visits.
I think if you have a full package 4
24 of documentation with the layoff of lectures and practical 25 experience is required, you probably have a lot of
()
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 l
(202) 842-0034
352 l'
L 1
information and you-may decide that you need a site visit, 2
but --
3 MR. CAMERON:
You are talking about right here, on 4
this alternative, right?
5 DR. WACKERS:
Right.
6 MR. CAMERON:
Okay.
7 DR. WACKERS:
It seems like a lot of time you are 1
8 spending on that, and I think the site visits may not be as 9
useful as you think they might be.
I 10 MR. CAMERON:
Any comments?
i 11 DR. MAURER:
Looking at lots of different t
12 programs, what you receive in a package application and the 13 difference in information you get from the site visit or if 14 you go.yourself is a world of difference.
If you are going b)
A/
15 to be approving programs, you have got to go talk to the m
j 16 candidates.
You have got to see them, face them, see the 17 lecture schedules and know what is going on.
I think site 18 visiting is important.
l 19 MR. CAMERON:
Okay.
That is a contra-point there.
20 Chuck, on that point.
21 MR. ROSE:
I want a site visit.
22 MR. CAMERON:
You want -- Chuck wants a site 23 visit.
24 MR. ROSE:
I think everybody needs a site visit 25 there.
Absolutely.
No exceptions.
1 1
t' ANN RILEY & ASSOCIATES, LTD.
Court Reporters l
1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
353 1-MR. CAMERON:
Like a bumper sticker, everybody I'h
(,)
2 needs a site visit.
3 MR. ROSE:
You're damn right.
q 4
MR. CAMERON:
All ristit.
Suntha.
i 5
DR. SUNTHARALINGAM:
While site visit is useful 6
and necessary, but I am not sure the NRC should be in the 7
business of performing site visits on educational 8
activities.
9 MR. CAMERON:
Cathy, did you hear that one?
10 SPEAKER:
This is radiation safety training.
6 11 MS. HANEY:
No, I am planning my travel itinerary.
12 MR. CAMERON:
Suntha's point was that the NRC --
13 DR. SUNTHARALINGAM:
Should the NRC he involved in 14 site visiting educational programs?
/
)
\\- /
15 MS. HANEY:
Well, I think in the case of the site if visits, where it is, I say, the non-ACGME program, it would J
17 have to be NRC.
But I think when you look at taking the 18 on-site visit, I definitely think we would need to involve 19 our representatives from ACMUI.
So, for example, if we were 20 going out to a board that certifies physicians, we would 21 take one of the physicians with us.
If we were going out to 22 a medical physics certifying organization, we would take 23 that individual with us.
And then we have just added a new 24 position to the ACMUI and that for a radiation safety 25 officer, and then that would cover the health p'lysics (O
(,1 ANN RILEY & ASSOCIATES, LTD.
{
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 I
(202) 842-0034
l 354 i
1 boards.
(
2 MR. CAMERON:
Okay.
This has been -- we are ready 3
to. wrap up, and I just want to ask if there's any final i
4 comments anybody has.
I would just say this is a great S
group of people, very knowledgeable, and you really did some 6
hard work during the day-and-a-half, and I think gave the l
7 NRC some valuable information.
8 I would just ask, any final comments around the 9
table on.anything?
Any --
10 DR. WACKERS:
Well, if I can make one comment.
11 MR. CAMERON:
Go ahead, Frans.
12 DR. WACKERS:
Alan seems to be disagreeing.
You 13
'know, we know about a large program, where everything from 14 CT and nuclear radiology and all this is evaluated.
We are
~%
(b 15 talking about a very tiny piece of mar.erial that has to be 16 taught that you really -- it is an outline of what, the 17 lecture that is being given, and, you know, and I think it 18 is really overdoing it.
19 You may mistrust -- you cannot trust anybody 20 probably, but I think, realize again what we talk about.
We 21 talk aoout the teaching of radiation safety, and we talk 22 about saving taxpayers' money.
I would like first to -- I 23 think.I can-look at whether a course looks appropriate, who 24.
-- you know probably who the people are teaching the course, 25 and then you can decide whether you want to go there and ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
^
F t
i i
355 1
check it out.
But I think, I mean you are not talking about l
)
2 a whole -- it is like activity programs, it is probably less 1
3 than 10 programs.
l 4
MR. CAMERON:
Okay.
This is on-site visit, again.
j I
5 Any last comments on anything before we adjourn?
6 (No response.)
7 MR.
4ERON:
All right.
Well, thank all of you.
8 We are adjourned.
9
[Whereupon, at 12:08 p.m.,
the meeting was 10 concluded.)
11 12 13 14
,b i
15 l
i 16 17 18 19 20 i
21 22 23 24 25 (f").
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
p l
REPORTER 8S CERTIFICATE This is to certify that the attached proceedings before the United States Nuclear Regulatory Commission in the matter of:
NAME OF PROCEEDING:
PART 35 PUBLIC MEETING WITH REPRESENTATIVES OF THE l
MEDICAL BOARDS 1
CASE NUMB,t:
I PLACE OF PROCEEDING:
Rockville, MD were held as~herein appears, and that this is the original transcript thereof.for the file of the United States Nuclear Regulatory. Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court reporting company, and that the transcript is a true and accurate record of the foregoing proceedings.
TM Ov1/T J n Hundley Official Reporter Ann Riley & Associates, Ltd.
O