ML20245D241
| ML20245D241 | |
| Person / Time | |
|---|---|
| Issue date: | 06/13/1989 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 8906270026 | |
| Download: ML20245D241 (74) | |
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I UNITED STATES OF AMERICA l
I NUCLEAR REGULATORY COMMIS SION i
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I$
BRIEFING ON PROPOSED RULE ON BASIC QUALITY ASSURANCE IN RADIATION THERAPY' i
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LCCII C.".l ROCKVILLE, MARYLAND 1
i D3I6l JL'NE 13. 1989
.ht.
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46 PAGES
} Ek'2 i. h3.0SS AliD CO., IliC.
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COCRT REP"RTERS AND TRANSCRIBER $
1323 P.hode Island Avenue, Northwest j
Washington-D.C.
20005 (202) 234-4423 l
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8906270026 890613 PDR 10CFR
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PT9.7 PNV
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.-_...____.__._____.______m.___
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O DISCLAIMER
)
This is an unofficial transcript of a' meeting of the United States Nuclear Regulatory Commission held on-1 June 13. 1989 in the Commission's office at One White Flint
- North, Rockville, Maryland.
The meeting. was open to public attendance and observation.
This transcript has not been reviewed, corrected or edited, and it may contain inaccuracies.
l l
The transcript is intended solely for general g -.,
informational purposes.
As provided-by 10 CFR 9.103, it is I
not part of the formal or informal record of decision of the matters discussed.
Expressions of opinion in this I
transcript do not necessarily reflect final determination or beliefs.
No pleading or other paper may be filed with I
the Commission in any' proceeding as the result of, or a
addressed to, any statement or argument contained herein, except as the Commission may authorize.
NEAL R. GROSS CoURY Rfpottft$ AND TRAW$CRISER$
1323 rho 0E l& LAND AVfNUE, N.W.
(202) 234-4433 WASMtNGToN. D.C.
20005 (202) 232-6600 I
-UNITED STATES OF AMERICA NUCLEAR REOULATORY COMMISSION BRIEFING ON PROPOSED RULE ON BASIC QUALITY ASSURANCE IN RADIATION THERAPY PUBLIC MEETING Nuclear Reguintory Commission One White Flint North Rockville,~ Maryland
-Tuesday, June 13, 1989 The Comminnion met in open session, pursunnt to notica, at 2:00 p.m.,
l.ando W.
2.ech, Jr.,
- Chairmnn, preniding.
COMMISSIONERS'PRESENT:
Lnndo W.
7,cch, Jr.,
Chairman of the Commissinn Thomas M.
Roberts,. Commissioner Kenneth M.
Carr, Commissioner Kenneth C.
Rogers, Commissioner James R.
Curtiss, Commissioner s.
NEAL R.
OROSS 1323 Rhode Isinnd Avenue, N.W.
Washington, D.C.
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1-LJ STAFT SEATED AT Tile COMMISSION TABLE:
l S AMl!El. J. CHILE, Secretary i
i WILLIAM C.
PARLER, General Counsel j
DR. BILL MORRIS, Director i
Division of Regulatory Applications Office of Research ROBERT BERNER0, Director.
l NMSS j
H(fGll TUOMPSON, Deput y Executive Di rect or Material Safety and Support J ollN TI: 010lt D, Section Leader l
Rulemithing Section Ho gu l ni i t.n DoveIopmeni ilranch, DRA, HES 1
JOHN GLEN *:, Chief of' Medical, Acadamic, and Commercial U<e ti r a n el, l
I DE Lili C !.tFCK.JORil, 11 1rectci-Nurlet.) I?e ru l a t o r y llesearch s
...a 1
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NEAl R.
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hashington, D.C.
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2:00 p.m.
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CHAIRMAN ZECH:
Good afternoon, ladies and
- j 4
gentlemen.
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5 The purpose of the briefing this afternoon
)
O is to discuss the status of the Proposed Rule on Basic 1
7 Ouality Assuranee in Radiation Therapy.
As many of l
8 you
- know, the Nuclear Regulatory Commission is 9
proponant to amend its regulations concer ning the of bypi oduct maierial 10 medical use 11 The proposed amendment would require medical I
12 licensros io implemeni certain quality assurance s t ept i
l 13 that wou l <l reduce the chance of m isadmin i s t rat i one l --i Thir propos"d rule vill result in a regulnfory reform 1C i hai u i 'l !
l' o e u '
or qunIiiy essuranen and w a :I 1 permit 1
10 e n f o r c e. it e - t erfion to be tuken when breakdowns occui, 17 br enLdown:
that crente an incrcased r i t i' io publie IF Lealih and sofels, l !I The st aff recently forwarded for Commission 20 review and approval SECY-89-171, which contnins the 21 proposed amendments to 10 CPR Part 35.
This pape' 2r e1so responds to ofher related Commission direct i ves 23 in the medien1 use aren.
Todny we'll dineuss i n wrc.
24 detail the contents of the staff's paper.
After 25 consideration of these matters, the Commissio" will be N E A 1.
H.
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N.h.
Washington, D.C.
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in a position to vote.
2 I understand that represent at i ves from the 3
O f fice of Research will make the key presentation 4
today.
5 Do any of my fellow Commissioners have any G
opening comments to make before we begin?
7 1f not, Mr. Thompson, you may proceed.
8 MR. T110MF S 05 :
Thank you, Mr. Chairman.
9 At you know.
this is an area that the 10 Commission has been providing increased attention to.
11 over the pant few years, both in the upgrading of some l i' ei our ietulations as wc11 as increased resources buth 13 for e t t e n t i <+ n and policy development areas, i
'~"
14 The ra n n item that we'd lik" to focuca your in at t ent ion in today as we go through th.ic i t, that the 16 foiluir inter thei we see in the applientjon of the 17 nucleet medicine activitles is about a t.
good as we see 10 in ans area of the medical application, as well as 19 nlmost any or the areas t hat we regulate So their i
20 pe t f o rmance,
as we see it, is pretty good, and the i
21 proposals that we have before you we think will 22 improve that.
23 Put the rate and the numbers and the 24 improvements that we see are going to be a small 25 numhet of are likely to be a small number, and the i
1.
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1 resulting bene fi t s in the quantification as we do our 2
cost /benefi t analysis may be difficult to see in the 3
precise terms as we normally
- see, that you would j
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norma))y see the cost / benefit of this type of
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rulemaking activity.
So just bear that in mind as we 6
go through the. briefing today.
That's one of the 7
challenges that the staff faces.
I think
_we i
8 ident.ified it in the Commission paper.
It 's something
{
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that you may want to explor e with us es we go through.
j 10 I:rfnre I turn it os e-r te Erle io' introduce.
i 11 t h r-speakers today, I would j u s t.
like to not e that et k
I '!
the table joinint{ ne is.lohn Glenn, for the first i
1:t tinw
.tehn is recently selected for the Dranch' Chief 14 of the Nucleus
- Medical, A c a d e rn i e,
and Industrial 1 T, Safel) Alea.
IIe joins us from hegion I and he will be 10 J ns t i umeo f,< !
- .i imp 3ementing ihe rulen i hn1 the i
i 17 Commisnion puts out in this area and I just thought I
i lh that ihir would lu un opportunity for him to be here I
19 today Obviously, he adds some of that field 20 experience that we value to have back here in 21 lle a dq u a r t e r s with us l
22 So with that, Erle" 23 CHAIRMAN ZECH:
Doctor Beckjord-you may I
24 proceed.
l 25 DOCTOR BECK.10HD:
Thank you, Mr. Chairman.
N F A 1. H.
GROSN 13P3 Uhode Jr.lond Asenue, N.b.
Kathington, D.C.
20005 202) 234~4433
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T L-J I don't have any additional comments to make 2
o li ihut.
The presentation on the Basic Quality 3
Assurance Program will be made by Doctor Bill Morris, 4
Division Director of the Division of Regulatory 5
Application.
Ile's accompanied by John Telford, who's 6
Section 1,eader in the Rulemaking Section of the 7
Regulation Development Branch: and Anthony Tse, who is 8
the Project Manager for ihis project.
Cli A I HNI AN Z Fril:
All riphi.
Fine.
10 Doci or Morra t you may proc.
I1 00cTOR MORRIS:
Thank you.
1
' blade On the first page of the handout, 13 we bas e nn outline of the briefing.
We'll cover the
~"
11 bncl.ricond t 1. a t led us
+o this point in ihe : u l e tt a l i n y 1 F, offor(,
to li a c i-os er some of 1he misadministration rekt.S 1C t h.. i bevr ca c u r r r il through ihe yeni.,
ditcus-the
!~
reculator3 object iver of this action, a summary of Ihe lH aiorndmen1s thn1 we 's e ptoposint, discuss ihe 19 ree ulat ory caide ihat would support that amendment, 20 inclu ling also the amendments that would involve the 21 in o d i f i c a t i o n io ihe reporting and recordbeeping l
22 requirements I'll talk nhout the benefi(n and l
23 imp,ctr of the rule and then our recommendai i ons.
24 Turn to page 2 of the handout, please.
25 iS1idel In Oct ober of 19 f17,
the NRU R
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.J NTAT H.
C RO F. C l '? 2 Ithode ]sland Avenue, N.b Washiorion. DC 20005
.202' 234--4433
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published two proposed rulemakings on quality 2
assurance for medien1 use of byproduct material, a
3 notice of proposed rulemaking on basic quality 4
assurance and a-notice of proposed rulemaking on 5
comprehensive quality assurance.
6 The Commission.was briefed on progress 'of 7
the rulemakings by the staff in March of 1988 and at 8
the briefing the staff described a draft final rule 9
that it was p,roposing on basic quaiity assurance that 10
<<nold e m b o d :.
a number.
of rather prescriptive.
))
requirements that would bn embodied in that rule.
12 The C o m nr i s s i o n subsequently met with 13 r eprer.en t a t i ves of the nie d i e n ] community in Apri.1 of 14 Ifmn io diu use ihe proposed rule wiih
.those lo individuals At that
- meeting, some of the
] f; representatives expresned concern t hat the draft final 17 ruln would have on adverse impact on medical practice IP h,+ause ii would either interfer with 1he medical 10 practice or because the cost of th.
rule would divert 20 resources ftom more important arens of medien1 care.
~
21 The staff was then
, directed by the 22 Commission to prepare an options paper providing 23 rulemakint alternatives..
In that paper, which was 24 submitied as SECY-88-15G in June of 1988, the sinff 25 recommended that a performance based quality assurance NPAL H.
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rule be developed, supported by a regulatory guide, so 2
t hat the formerly prescriptive requirements in' the I
3 earlier draf t rule would now be. relegated to the
'4 regulatory
- guide, and would therefore be less.
{
5 intrusive on the medical practice.
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6 The Commission, in its SRM dated' July 12th 7
of
- 1988, approved that recommendation,. along with 8
other recommendations the staff had made.
1 9
Subsequen t l y, the st ei f went to work on.this project 10 and bed a
s e r i e r.
of meetings with medical-1 11 organi7ationn as had been directed by the Commission, i
k 12 and sul2( ii ed comments from agreement siates and other I
l 13 interesIed groups.
i 4
24 T h r t. "
meet iner included a
meetint in JG November with ih" Qualiiy Assurance Subcommittee of J
1G the Ad i N ors Comeitiee on ihe medica.1 uses of inot opes 17 und they reviewed the process of developint a
1 1H per forn ane r based rule and reguintory guide i
19
- 1. a t e r, the staff held a public workshop in 20 January of 1989 in which the revised basic QA rule and a
21 regulatory guide were discussed with various medical 22 u t, e licensee personnel, including physicians, 23 phystrists and technologists.
That was a round table 24 discussion between those individuals and members of 25 the o t :s f f I
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L.i N1: A I R.
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W a r. h i n g t o n,
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In
- March, the staff also met with the 2
American College of Hadiology to discuss t he - NBC's 3
draft regulatory guide and the ACR's draft Quality 4 ~
. Assurance Program.
The American College'of Radiology 5
li s in the process of developing a
comprehensive 6
Quality Assurance Program that would be designed to be 7
adopted in whole or in part' by t he. members 'of the 8
American College of Radiology.
9 Now, the NRC' staff has used this information 10 gathered in t h e r, e met tings and conducted n lot of.
11 onalysin i f r. e l f in developing the rule and regulatory 12 c u i de-that has been transmitted to you in the SrCY 13-paper.
14 (S l i d, 1.. t ' s move o.n to page 3.
If I can 1 ",
assess for a moment the misadministration experience 1G that has been the concern t hat would be nddresr.ed by 17 the ule 1H 1)urinF ihe period from 1980 to 198H, there 19 were a iotnl of 88 therapy re]nt ed events reported to 20 the NHC and approximately 3200 diagnostic related 21 events.
Those therapy related events included 23.
22 r e p o r t.<.
thni involved administration of Iodine 131 23 origiunlly intended to be in the diagnostic range of-24
- dosage, but which turned
- out, through
- error, to 25 netually have.resulted in doses in the therapy range.
NP4h H.
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so, those events-have been included as-therapy i
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categorized events in this analysis.
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3 If you-extend
~these rates of 4
misadministration per year that were reported based on 5
NRC licensees to include ~ a projected rate for all' l
6.
Iicensees, the NRC licensees and the agreement state 1
7 Jicensees, it turns out 'that you might estimate 8
approximately ~ 30 therapy 'related events and 1200 P
diagnostit related events per year.
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10 To give some perspective on the
- r. i g n i f i c a n c e -
1 11 of Ihese events, there would be approximately. 180,000 i
1 12 therap3 adm in ist r a t i ons in
- a. year and approximately 7 j
i IP million di agnos t ic' administ rat ions in a year, to get Ii eomo feeline for ihe act ual error rate or t h er numb'er j
in of events per administration that would be occurring.
j 10 COMMISSIONER ROGERS:
Excur,e me.
il u s t 17 befere you l.nse
- that, those numbers-don't seem to 1H conne< 1 togeth"r exactly.
How did you get the 30 and 19 1he 1200?
Whnt'n the hasis for those numbers?
20 DOCTOH MOHHIS:
Okay.
You'd take the 88 and 2) the 3200 and divide by eight, each of those by eight.
22 There are essentially -- let's see.
The.e are --
23 COM41SS10NTE ROGERS:
And I get 11.
24 MR.
THOMPSON:
- Remember, this-is 01.1 25 1icensees -
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J DOCTOR MORRIS:
Yes, this is all licensees.
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2 MR.
THOMPSON:
-- which includes agreement j
3 states as well as NRC.
So tbey're about tbree times.
4-the number or two times the number in the agreements l
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5 states that they are NRC licensees.
So, we have about I
6 one-third and they have about two-thirds.
i 7
COMMISSIONER ROGERS:
Okay.
{
8 DOCTOR MORDTS:
Approxinnte number is 2500 1
9 NHC licensees and 5000 agreement state licensees.
j 10 cnMMiSSTONER ROGERS Pino.
Sure Okay Il DOCTOR MORRIS:
Now, this sense of what the
.)
12 at e of o d n. i n i. t r a t i o n > is netds to be supplemented by i
1:1
.s o m e thought about the possibility for horr to 14 petients f r om these misadministration.
There are n i
in vorlety of situalions that enn arise in m e d i c a.1 l
i 1 (i ir.atment and o r r o r.+ can lend to d o s e t: either above or 4
i 17 below what was intended.
It's been difficult to 18 develop aat simple assessment of the pot ent i al snfety 19 nnd health implientione, of misadministration.
I 20 So
- far, the beat that the s t. a f f has been 21 able to do is to refer to case by case assessments of l
l 22 past administrations by NRC medical consultants or by I
l 23 the licensten themselves to indicate something about 24 whether those misadministration involving overdose 3 25 to patients might have resulted in some adverse health NFAI R.
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1 e f fect s Some analysis of this was indicated in the 2
rnelosure 5 to SECV paper 88-15G, of the potential 3
harm that could occur.
4 One other point t hat we need to keep in mind i
5 is that there is also a potential adverse health G
effect to patients who erroneously receive doses below
'T the 1cvel necessary for effective treatment of their l
R condition.
So, we shouldn't ignore that possibility 1
0 e il brr a-we look at this potential, but we just have 10 not bc en ai> l..
te come u ti wiib eonm criterion or some-l' quantitn43v-way to woigh in these health effects.
It 1:
s o eno to be n e c e r.<. a i y 1o do it on a case by c a t. e 13
!. % is l
14
' S l i ile Well.
going on to paye 4 of the-l' h m J c.u t,
and havinc recognized t hat there are some 1G uncert ain t ies involsed of these error rat."
and 17 understanding how Iarge they are and whni the health 18 offoet
- nie, t hi bottom line we believ.
in that there 19 would ie a net benefit to patient safety if the rate 20 of errors and medical use of byproduct material can be 21 reduced.
We just simply can't quantify it very well..
22
' Ibis is the basic healt h and safety object ive of the i
23 proposed regulatory actions to reduce that rate 24
- Now, it should be emphasized that although j
26 ii would be desireable to eliminete such errors 1
e f
i NI Al U GHOSS l
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20005
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altogether, this should not be expected.
There will t
2 probably be a residual number of errors that will i
probably_ can't devise any. means to 3
occur and we 4
eliminate and eradicate those errors altogether.
5 Also, while we want to reduce the error rate 6
as much as we can, we want to do so. at a reasonable j
7 cost and with a
minimal intrusion into the way 8
. licensees might want to conduct their medical i
D practice.
So, we have to balance these factors too es 1
10 we proce"d.
11 So.
beenuse of the concerns ihnt had been 12 expressed, and these concerns I just mentioned to you, i
l 13 the approach i ha t we've adopted ie
'to-i,1 a t e the 1 -1 C o m n. i s c ion'<
requirements for licensees-to implement l5 b ri b i r oualliy aN80rance p!'ograms in H general rule and regulatoq guide the more specific j
10 pr os i d.-
through n s
17 ite> in that would be acceptable in d e v e.l o pi n g such 18 programe hy allowing this flexibility, we would hope i
i l !!
to b:. e a
minimal int rusi on into ihe conduct of 20 medical practice.
And niso we've noted that there 'has been 21 p
22 some difficuliy experienced by 1icensees and by our 23 i nspect :i on enforcement staff in interpreting the 24 current requirements on, reporting on 25 mi t.admi n i s t rat i ons..And so an addiiionni obj ec t i ve of NEAl, R.
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the action is
.t o approve the ability to detect and 2
correct a breakdown in OA programs by revising the 3
reporting and recordkeeping requirements.
4 (Slide)
Move on to page 5 of t he handout.
5 CHAIRMAN ZECH:
Before you go to page 5, let G
mo just note that your reference to reducing the rate
~
7 of errors in medical use o f-byproduct material, we 8
appreciate the fact that the errors are not very high 9
and we appreciate the fact that the. medical profession 10
<l o r - a con <rn11v excellent job in not only d i a r n o s i t..
]1 but niso t reat men t while using byproduct material.
I '.
W"
.to.not want to int rude in the medien]
13 profession buriness of health care, but we do feel 11 tha!
thore'<
roon.
foi improvement.
That'n the 15 i n,p o r t a n t mowage we're trying to give to the medical 10 community and we would hope that the medical community l 'T would a l <- recognize that -- we recognize the errors 18 nre 5, n n i l, but uo would like to t h.i n k that there is j
l 19 room for improvement and we'd like to think that they I
20 recognize that also.
21 DOCTOR MORRI3:
Yes.
l 22 CHATHNAN ZECII:
Al1 right.
You may proceed.
i 23 DOCTOR MORRIS:
Okay.
Page 5 again.
I i
24 The proposed revision of Part 35 now 25 involves a
new
- section, 35.35, which states the l
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1 requirement that each licensee should implement a
1 2
basic Quality Assurance program.
A 1icensee's program 3
must be designed to meet certain performance l.
4 objectives which are included in the amendment.
That i
5' is, the rule would specify or state what the G
Commission wants' to accomplish, but it would not 7
specify how this is to-be done.
These details would R
be 1ef t to the 1icensee.
O The amendment would also require the 10 1icent.ee to conduct iegalar audits of fhe Quality-11 Assurance ptocram that he would implement and to 12 evaluat e these audits, so that timely re v i s.i o n s. can be i
1 :'
made in the prograu to correct any deficiencies he 14
- n. i c h i det ect in (slide i Moving on to page G,
on pagen C,
7 II; and 8,
the specific performance ob,i e c t i v e n that we 1i propose are summartved here.
These o h j e e t i t e r, were a clear indication of 18 selected because they provide 19 Commission expectations for effective medical quality f
20 assurance programs and because they address the kinds 21 of human errors which-have resulted in report ed 20 misadministration in the past.
23 If
- followed, we believe these objectives 24 would help assure, for example, that the medical use 25 of byproduct material is appropriat e given the j
NrAt I?, cposs 132:; 1thode Isined Avenue, N.W.
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p a t i e n t ' s.
condition, that prescriptions or other 2
instructions are documented and
- followed, and the.
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correct patient is treated.
4
.I don't. propose to go.through each of these b
in detail.
If there are no questions about these G
objectiver, 1 propose we go on to page 9.
7 Yes, sir?
8 COMMISSIONER ROGERS:
How is the diagnostic 9
referrol procedures manual developed?
Who'd develop 10 thot' 11 DOCT0fl MOIIRIS:
I believe ihe 1icent.ee would 12 develop that 13 COMM I S S.T O NTU ROCERS:
Then ihev wouldn't be 14 common t h e n ':
~
15 D OM 01: MORR1S:
Wel],
J'm sure t hat ihere 1G nm y 1c s om.
commonality among the v a r i o u s, l i c e n t, e e s,
17 but
.1 don't t h.i n i: t h e r e ' r.
nny sinndard manual that i
18 J've h e,, r d of.
J 19 A13nne else know of a 5,tandard?
I 20 MR. GLENN:
Well, let me comment.
21 DOCTOR MORRIS:
Yes?
22 MR. GLENN:
I think it's usually within an 23 institution that they have developed a
clinica]
l 24 procedures manual.
But it's quite frequent and i
25 already existt. for moni of our 1icenseen ihat for n l
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standard procedure such as a liver scan or other kind 2
of i n n rin g study, that they have already prescribed given ' clinical 3
what the normal dose will be for a 4
indicutdon.
5 COMMISSIONER ROGERS:
As developed by each 6
licensee?
MR. GLENN:
lly ench.1icensee.
8 CHATHMAN ZECH:
All right You may proceed.
IiOCTOR M0l?l!IS:
(Elide i On slide 9 then, we 10 indirate the proposed implementation. of ihin new.
Il Se" tion 35.35.
The effective date would be six months 12 after publication of the final amendment in The Ey r.
Ih that da t e, we would expect the lh Tinie i n i Ueri t
.14 1ironsee io rubmit written cet li ficat ion
't o
'the 1&
reyional office ihn!
n Quality A n s.u r a n c e Prograr.
10 meetine the objeciives of the Commission's rule had 17 been i m p l eir e n t e d.
1P
- Then, ev en t u n 113,
at the time of license 19 renewal.
the licensee would submit the Cunlity 20 Assurnnee Progrnm itself for review by the staff.
So, 21 the program would be reviewed and approved in. a 22
- s. e q u e n c e related to the schedule for license r e n ew-a l 23 for the number of licensees out there.
l 24 COMMISSIONER ROBERTS:
What is the length of 1
25 these licensen?
N T 41. }l GROSS 1323 Hbode 1sinnd Avenue, N.W.
W a r. h i n e t o n, D.C 20005 (202* 234-4433
~ 1 i
i j
l 18
)
- J l
MR.
THOMPSON:
Five years.
There's a
2.
sequence, I believe, every'five years.
3' COMMISSIONER CARR:
Is it intended that the J
4 license renewal be dependent upon-approval of t hat
]
5 program?
G MH.
THOMPSON:
That. would be the intent as 7
part of-the license renewal program, that you would, F
in fact, conduct n review and have yourself from a 9
ITrensing standpoint that that
-program met the I
'f D i r e fr e n i.
lO I e C o.1 a l t i '
=
r(
11 What we were t rying to do is rather than all i
12 of sudden hus e
- 2. 000. li cense amendments t hat have
~
1?
fell on un on one day with' a fairly limited r,tnff is o what w- 're r<nlly trying io do is te get ibis
~
14 Lo 15 Oualit)
A r. = u r a n c e Program put in plare as bes t ihat 1
10 tbe h ot.p i t o f know how to do given the guidance that 17 w"'d he developing in the pilot program, l.ikewise 1
IP then.
compl<te our ful1 implementation io the
]
4
] f3 l i c e n s. i n t p r o c<.s v.
as the hor,pitals come up for their l
20 license renewn].
21 So, it was kind of n
two phoned-22 implementation program and then we.have a special 23 contraetor ihat we iniended that ihe Commincion io 24 giving its resources out to promptly go out when they 25 has e certified that ihey have the program implemented I
NTAl R.
GPOSS 13P:' khode Island Avenue, N.K.
Wnshington, D.C.
20005
- 2021 234-4433
19-1 to audit it just to see how the program and to see 2
that they are impl ement i ng the program that they 3
committed to internally, not necessarily just the 4
program precisely as it might finally be in their 5
license after our license review.
G COMMISSION 1'R C ARR:
Is it intended to audit 7
everybody or just. pilot programE,7 R
MH.
THOMPSON:
The pilot program will be D 4 conducted early in the a r t i v i t i e r-and then once the 10 rule goe. in pince nnr1 firal, we will audit everybody.-
11 COMMISSIONER CARR:
In addition to reviewing l 'J the piogram at the licent;e renewal" 13 MR.
THOMPFON Thnt's correct.
We have i o-14 do lhe 1 i c e n t..
ienocaJ any way-Th i r.
wiIJ juti be one ir o., p o r t that we look ut when we 'd o the license renewal.
10 lt u t t he key element there really i t.
the audit of what 17 they're doing at the hospita'),
and I
think.that's 1H where lhe e n fet y improvement's.
going to occur
.a s ID opposed to ihe. piece of paper.
You know, you con get 20 a great piece of paper and not implement it.
21 COMMISSIONER CARR:
I just wonder if i t ' r,
.22 going io be wortb doing botb.
23 MR.
THOMPSON:
W e l l.,
we've got to do the 24 license amendment anyway.
25 COMMISSIONER CARR:
But that wouldn't have NEAl R.
GROSS 1323 Rhode Island Avenue, N.W.
Kne.h i n gt on,
D.C.
20005 (202) 234-4433
1 1
I i
I 20 l
1
-_J 1
to be --
2 MR.
THOMPSON:
- Remember, ihe 1icense 3
amendment is a piece of paper that they typically 4
would look at it --
5 COMMISSIONER CARR:
- Yes, but I mean that I mean the G
part of the program wouldn't have to be
- 7 license wouldn't have to be. contingent upon approving
.j 8
the program i f you also looked at it when you went out j
9 and did the audit.
3 1
l 10 MH-THOMPSON:
- hell, that's cerininly.
11 somethine w-
- r. n n look at during the comment. period..
I '!
That mos be an appropriate way to 13 COM\\llSSIONER CARE:
l'm just trying to cut i
i 11 out o om.-
of the munpower intensive part of the ir p rob l er :
1C MR.
THOMPSON:
Well, we stand behind you.
17 But that was the approach taken, to just have them 18 ceti,fv i hat it's i<n place and that we can go out and i
19 audii if 20 CHAIRMAN ZECH:
All right.
Let's proceed.
2]
DOCTOR MORRIS:
(Slide)
Moving on to page i
22 10, t.taff han doveloped a draft regul at ory guide which l
23 provides an acceptable way to meet the requirements of 24 the proposed amendment.
The specific criteria in the 25 guide address each of the performance object ives in I
t_
_J NEAL R.
GROSS 1323 Rhode Island Avenue, N.N.
W u s.h i n g t o n,
D.C.
20005 (202) 234-4433 l
l 21 1
the rule we went over just a
few moments ago.
i 2
- However, as stated on page 11 of the handout, the j
3 guide is not a Quality Assurance Program in itself, 4
but it provider, guidance to assist the licensees in 5
developing their own program.
6 I point out that now that the pilot program 7
is an essential step in having us learn mo re about R
whether we have an ef fect ive guide in proposed form 9
and to cortert it and make adj us t men t t-as we learn 10 m o r.-
about that guide during the pilot program.
11 In reference to the previour discussion, I 1;
would point out that there will probably I.
n good l'
chane" to learn more about this license renewal and 14 the 1 i < erm i n e p r ot duiiny ihe pilof p r o g r n in because m-IP NMS9 hm requ: sted that we include 12 caser in the 1G pilot j,< gram which would rive an in de p t l.
review of-l 'i how t hat process would go, so we'll know more about JU how i lo final appi orn l
- hould be engaged 1ecause of 16 ihat niotrom.
20 (S1idei Moving on io s1ide 12, p1 ease.
23 1
just wanted to mention, as I mentioned 20 before, there have been comments of representatives in 23 t he medical community and the staff members who have 24 been involved in the inspection enforcement process 25 that ther.
could be some benefit from clearer l
l NJ:tl it C H o c. S
)
132 Rhode Island Avenue, N.W.
hashingion, D.C 2000; 202' 234-4433 I
.o.
)
I 22 l
I L-1 reporting and recordkeeping - requirements.
The staff 2
has developed and is' proposing to the Commission a 3
modification to the reporting and recordkeeping 4
requirements which has the ob,j e c t i v e of better 5
identifying cvents indicating breakdown in the quality G
assurance.
l 7
Two hinds of events are included, procedural I
8 errors that might not necessarily result in an i
9 erroto oun dose to a paljent, and those errott that i
10 rould result i r.
erroneous doses to patients.
So.
the.
i s
lj procedurn) errore, might be thought of as a precursor 12 to
- n. m o serious breakdowns.
But they would be 1?
included in ibem new 1ypes of events.
l 4
I i
11 (Slid <.
. Slide 13.
I 15 h'.
note ihat among i h <> s e new r e p o r t i n t' and 1r recordkeepint r m; u i r em en t s, we've added some io insure 17 thet i h <- perl'ormance ob.i e ci i v e n in the new 35.35 are 18 beine ei d <i r e t4 s e d by the
- licensee, and the st ruct ur e 19 would have been changed to account for the fact that 20 we would replace the single term " misadministration" 21 by terms now called " therapy events" and " diagnostic I
22
-events."
Thit, is going to, we believe, clarify some i
l 23 of those efforts by our licensees and t h a-inspectort.
21 in determining the nature of these events more 25 clearly.
I h-NI; AI, R.
GROSS 1323 Rhode Island Avenue, N.W.
honhinrion, D.C.
2000r.
(2021 234-4433 1
,=
23 1
(Slide)
Moving on to page 14.
2 These more specific reportirg requirements 3
would clarify certain circumstances that have arisen 4
to better inform people as to what kind of reports are 5
required and the basis for these reports, for example, G
it would now be clear that a lost brachytherapy source-7 is to be reported under Part 35, whereas in the past-8 this has been a mat t er of some question and took some 9
deliberation, finally to determine that that was 10 appropriate when in the past it would have seemed more.
11 appropt i al e to just simply report it under P a r; t 20.20.
i 12
- Also, i lm r e would now be a gtaded approach 13 ti.
the reporting requirements.
There would be a
1 -1 sv ri e<
of reriris that would be required to yo to ihe I
10 licenseo rn a n a g em e n t and cert ainly provide him 1G pe rsp.ac t i s <
on whether his Quality Assurance Program-17 is having problems or not.
Another series of reports 1R at anollor level of s i gni fi cance would come to the 19 NRC 20 (Slidel page 15, we turn to the issue of 21 trying to look at the benefits and the impacts of the 22 proposed amendment.
- First, we need to go back, 1
23
- believe, and look at an annlysis of those past I
24 mi s a dmi n i s t r a t i ont, that have occurred.
26 The staff has analyzed ihe 88 therapy events NPAI. R.
GROSS 1323 Rhode Island Avenue, N.W.
Was hi ngt oti, II. C.
20005
'2021 234-4433
2a j
a i
kl 1
reported to NRC between 1980 and 1988.
This analysis 2
was performed by Anthony Tse of the Office of Hesearch 3
and Sam Pettijohn who was then with AEOD.
What they l
1 4
did was they considered'the degree-to which specific i
1 5
provisions of the regulatory guide would have been G
effective in preventing each of these 88 events that 7
- occurred, a r, s u m i n g that these provisions would have 8
been effectively implemented by the licensees.
judgment on each event regarding i
9 They made a
10 the decree of certninty they would atioch io the.
11 prevention of the event by implementing the regulatory 12 guide Thene judgments appeai in some detail in 13 Appendix A of t he regulatory analysis that accompanies 14 the amendment Wha!
their judgment was war i hai In essentially CD of the 88 events they felt pretty 1 I:
.trongly con]d has e been prevented.
Fourieen u t. b e r 17 ovents.
ther believed it would he likely to be 18 prevented. and the remaining 14 events they could not 19 det ermi na or they ware felt that they would not be 20 prevented.
21
- Now, this is a retrospective analysis and 22 t h e r r, ' c just a limited amount of assurance that we con 23 get about what wi11 happen in ihe future from it.
Bui i
24 it's the besi we can come up with to try to get some 25 insight at to the effectiveness of these new measures.
t NTAL D.
GROSS
.1323 Hhode Island Avenue, N.W.
Washintton.
D.C.
2000n
-2021 231 1433
25 1
The result of that analysis, when you just 2
assume that of those 14 events that were likely to be 3
preventable, just assume 50 would have been and 50 4
would not have been and you come up with about 75 l
5 percent of the past events may'have been prevented.
I i
6
'I want to. point out that there. are others 7
who might perform this analysis and then could arrive 8
at different judgments.
We've tried to document 9
enough i n f orma t i on-in the regulatory analysie, so that 10 snriout people could make t hei r own ask ssmente, just.
Il from a rai her superficial reading of what those events 12 wer e l i l: o 13 P, u t those a n a l ys es, appent.fai r1 y reasonable 1
14 te m*
1 t h i n i.
that one could.be o p t i m i s t. i c - that 16 ihere would 1,e a poi en t i al for reducing ihe rate of i
in erron in medical u s.. e based on that analynis, 17 slide' Moving on to page ] G, lR Howeser, we need to consider that there are 19 ofher f act ors ihat could somewhat change thir picture 20 about the actual reduction error rate that might 21 occur.
11 could depend on several factors.
One 22 factor is the Quality Assurance Programs adopted by 23 the l i e r n t. e e s.
These programs may include measuret.
24 different from those in the regulatory guide.
We're 25 giving them flexibility to clo something - you know, NEAL R.
GROSS 1323 Hhode, 1sland Avenue, N.K.
kashincion, D.C.
20005 (202.
234-4433
l 2G I
I L.J l
to make their own judgments about what would be 1
2 effective 3
Fven if they adopted the measures in the 1
4 regulatory
- guide, the guide does not include 5
provisions for independent checks of every step of the 6
medical adminstration process.
In other
- words, 1
7 thece's not always a second technician around to watch 1
8 over the firsi during each step of the process.
And f
9 whil.
we have provisions for over checht of 10 ca l culai i one by p h y r. i c i s t s,
we don't do evervihing.
i l
11 with redundancy j
1 61,
(' Y e Fl Will'It jlf o\\ ib.I oliF I (31
}l u fD D D
}*
e l ti i
1.
redundaner a r <-
- included, ii's possib!e that bot h l
11 individunl-
- nvolved can make the same error rom nome F
cc m wne n i
< out-eif r i ihat might exist.
in A
j t h e r."
hinds of fnetore might have a JG e
i 17 bearint o:
hou effective the mea.sures would be In
]H
<.1 h e i w<.id-the point in t hai when you're at a very 19 low human error rai o already, it may be difficult to 20 nitain some t.ub si n n t i a) reduction-in error and we 21 ran't be sure nbout this.
22
- Also, we need to remember that there would 23 be varyinc degrees of effectiveness, of implementation 24 of the programs by the licensees.
To nehieve this 25 errer let's call it a theoretical error rate, it rq L _J NEA! U G R 0 9
132:' Rhode Island Avenue, N.W.
Lashington, D.C.
20005 (202i 234-4433
q j
'i l
27 1
1 would require some diligence and care on the part of a
i 1
2 the 1icensee siaff to achieve what we think is the
]
3 goal.
'1 finally,:when you compound these cert ainties -
5 that I've just mentioned. with the difficulties G
mentioned earlier in quantifying the impacts on
)
7 patient health for misadministration,:the fact that we y
R have difficulty cha rnci eri r.i n g i ha t in a clear way, i1-O means ihai
)i's somewhat difficuli for us to quantify l
30 ihe degree'io which pationt snfeiy would be approved-11 by the proposed amendment This does not mean that e 12 qualitafivo judgment cannot be made ihai ihere wi1] be J'
a benefii howevm 1t's j u r,1 difficol1 io quant i fy.
{
11
' S '? i d e Continning on page 17, we wan?
to I
15 pnini out that there is that benefit niso that comes i
1G from a r, improved ability
-t o detect and report through 17 the revised reporting and recordheeping requirements i
1
\\
1R that should improve our bnsis for inspection and 1
l 19 enforcen ent a
20 One other point to remember is that there i
]
21 are measures that are in the proposed rule, such as 22 the annual audit by the licensee in evaluation of has 23 pr ogram and feedback to correct
- errors, that could 1
21 find errors that we have not been nble to pinpoint in 1
25 our regulatory guide that could also have a beneficial I
NE Al. D.
GROSS 1323 Phode Island Avenue, N.W.
Washingt on, D. C..
20005 (202) 234-4433 l
___-________.__m-________
g 1
1
~l
\\
28 i
1
!lJ l
effect in reducing errors also.
2 (Slide)
Moving on to page 18,. point ing out 3
that we-attempted to quantify the~ cost to licensees of 4
'the var.ious steps in this process.
The cost of 5
developing.
and implementing the basic-Quality l
G Assurance Program required by this amendment will j
i
'T depend on ihe mixture of medical administrations of
{
8 various 1ypes that would be conduct ed by 1icensees.
O That in, some 1iconsees have combinations of j
i 10 4 ifferent 0inde of practices, d i e g n o n t'i e s,.
11 ieleiherapy br achvi herapy and radiopharmaceutical 12 thernp3 We don't have a det ai led breakdown of how a
1 s
19 i bic work-out fer the licinsees, so we've j u r.1 tried i
11 i o charueterire ihe cosi io ihe ]icensees in ierms of
]
j I T.
- imp'. Tied cateeories, q
l 1G MH. 1110Mps0N :
Is ihat per year'
)
1 "'
IIC C TOR MORRIS:
This is annua).
18
- 1. e t me point out on page 38 that what we're i
19 i n1kint' about here on-this page when you look at the l
20 f i g u r e s, are annual costs then cf the development for 21 the various licensee types.
22 The other factor that we've considered is 1
23 whether or not the licensee might be already 2 e1 implementing good basit: quality assurance practices.
large number of the licensees are already 25 We thinh a l
J l
y
/
NEAl H.
GROSS i323 Rhode Island Avenue, N.W.
hash i net on, II. C 20005
'202) 234-4433
3 1
29 1
impicmenting the provisions of this rule and reg.
i j
2 guide and that there would be some fraction -- we're i
3 estimating 20 percent in our cost analysis would have 4
to take significant measures to upgrade their programs 5
to what's in ihe-rule and reg. guide i
G So, the range then that we estimate is it 7
went from maybe as low as $100.00 a year that would be l
F1 averaged over the first ten years of experienet> to l
D d"velop and put into place and have the review j
i 10 conduct"d of the OA Program up to $4,000.00.
The.
11 be!i er licensees would have a smaller cost and those l
I i
12 licennee' who had a combination,
- say, of d i l'f e r e n t j
13 therapy type practices and were not currently adopt ing
{
l4 ihose OA praetieen woold hase to bear the h i c h e.r cost.
15 Whon you lotal this up for all the 7500 10 1 i c e n <. ",m, *: U " and ogieement siates, it would com ta 17 approximately f4 rillion a year ori that's assuming l fi this 80 percent are already doing mout of the good l !I things and 20 percent would have io upgrade 20 (Slide)
On page 19, we also mentioned that 21 there would.be some increased costs just for the 22 revised reporting and recordkeeping requirements 23 Those costs could go for -- taking into account all 24 7500 licensees, from $270,000 per year currently to 1
25
$344,000 a year af t er the revisions.
I 1
NI' A l II. GilOSS 1123 Ithode Island Avenue, N.W.
hashington, D.C.
20005 l
'202) 234 4433 l
30 rm I
i 1
1 should point out here that of course only 2
those licensees who experience misadministration or 3
errors would have to make these reports to the NRC and 4
make the reports to the licensee's management.
5
- Well, upon considering. the uncertainties G
that we've mentioned here in quantifying the benefits
'T and ihe impacts of fhe proposed amendment, the staff, 8
n r.
Mt Thompson mentioned, is unable 'to determine 9
w h e t. h e r the increases in patient safety will outweigh 10 ihe economic or ofher impacte.
It's.been ou r-11 intention to develop a rule and reg. guide that would 1P c a u o <- 1iii1e w no intrusion in ihe 1icennee's ability 13 fe praci i ce medicine as he chooses.
li And we've also had an ob,iee t i ve of in mininiving unnecessary demands on personnel or 10 ntarfing.
1:owever, the degree to which we've been 17 successful that I believe will be determined io some 18 "xient thiourb the public comment procens nnd the 10 p1 ' i program.
20 During that
- time, we will be taking the 2]
initiative to continue interacting with 22 r e p t e m e r.
atives in the medical community and to 23 continue to learn how to improve the rule and the reg.
24 guide in our assessment of the benefits and the 2r impacts from 11 I
NI:A1 ll. G il0 F. S 1323 Rhode Island Avenue, N.W.
j W a r. h i n c t o n, D.C 20005 (202) 234-4433
e l
I 3]
l 1
(Slidel So, in that spirit, on page 21, 2
we've not ed our recommendation t hat the Commission 3
direct the staff to issue The Federal Restister notice 4
and proceed with the pilot program.
5 That concludes ur presentation.
)
i 6
CilATHMAN ZECH:
All right.
Thank you very j
7 much.
a 8
MU.
THOMPSON:
We're prepared to respond to-
)
I' 9
any questions, Mr.
- Chairman, that you or the 10 Connic ionero have l
11 CilATRMAN ZECH:
Thank you very much, 12 Questions of my fejlow Commissioner
- 13 Commissioner Roberts?
14 r0"M1 R S 10NCH HOlil: HTS :
No.
15 CHATRMAN ZECTI:
Commissioner C a r r
1C C O S"'i! % f T O N F F! CARR:
On your rejil ac a nr the 1
17 werd
" misadministration" with
" therapy e v e n t s. " -and j
I f:
"dingnostie es en I e, "
1 don't have any problem with 1
19 thnf or for as the reporting system-goes, bu! I think 20 when it comes time for citations or enforcement, we 21 ought to call a
spade a
spade.
If it's a
22
' m i s a d m.i n i s t r a t i o n, we should state 1 1 -.
It's obviously 23 an error that tot the wrong patient or the wrong dose.
24 1 d,n't ihink we ought to iry io gild it over a 1i t t l e-25 bit by just calling it an event.
N1: Al H.
GHORS 1323 Fibode Island Avenue, N.W.
Washington, D.C "0005 (202i 234-4433
4 O
f 33 l
{J l
L l
MR. THOMPSON:
I think that's the way we see 2
ii.
I n. fact, that puts it in the enforcement arena 3
where we can take enforcement action as opposed to --
4 COMMISSIONER CARR:
That's okay with me.
I' 5
mean there ought to be some levels like we got in 1,
G 2,
3, 4,
5.
7 MR. THOMPSON:
Absolutely.
Yes, sir.
8 COMMISSIONER CARR.
If it's a
9 misadministiatson, that's what we ought to tag them 10 wi t h, I t h i n l:
ll MD.
Tl10M P SO N :
And the severi t y levels, if 12 you'se got ihe wrong patieni -- you know, there are 13 al1 s e r i s.
of -
the development of ihat iype of 14 enforcemtni ptotram is just not available to us today in and would act ually be part of what we would deveJop on l fi 1his prott am.
17 CO*1 MIS 910NER CARR:
11 seems 1o wo ihat ii IP would ho a betior use of manpower io just -- I guess 19 you're coing to look ai this program in. our hospital 20 inspections that we make now that are unannounced.
It 21 seems to me that after they certify it, since they're 22 cert i fying ihat ihey've got it in place, that we 23 should pick it up in those inspections and maybe make 24 more of those rather than use our manpower to sit and 25 loot at paper because you're going to -- you won't i
I
- i. J NEAI. D.
GHOSS 1323 Ilhode Island Avenue, N.h.
W a s h i n g t o n.,
D.C.
20006
/202) 234-4433
-4 33 1
really'know whether that program is working or not by 2
a u d'i t i n g the paperwork until you get there and look ut 3
it and see how it's working.
4 So, you can take that suggestion.and meld it 5
in with the pilot program and see what flops out.
6 MR. THOMPSON:
I think that, in essence, is 7
our int ent.
There is going to be some difficulties 8
maybe with those who are right at the renewn) 0 borderline and the inspection borderline time frame.
10 So. we'll look at that, but that it the concept 11 COMMISSIONER CARR:
I assume if they've 12 applied fo n license innewal and we're still. looking
- 13 at the paperwork, their license is extended 11 a u t ona.t l ea11y 1ite 15 MN.
PARLER:
It does as a mai t e r of law.
1C Wh.ther or no' ihey wan! ta change it as o
maiter of 17 policy as another question If they don't change it 1 f:
a t.
a motter of policy, an v matter of law, if si't Ihe 19 iime of renewal, the license continues in effeet.
20 COMMISSIONER CARR:
That's still going t o be 21 the case.
22 MR. IPRNERO:
The sheer number of 1icensees 23 means we have to focus the resources on ihe mosi l
24 effectivo use.
That we see as catching the licensees 25 nominally 20 percent at a time in the renewal process, NEAl.
R.
GROSS 1323 Rhode Island Avenue, N.W.
Washington, 11. C 20005 (202) 234-4433
l, 34 I
I L J l
and that's the opportune time to have the program, 2
1ook ai the program, audit it, and renew.
3 COMMISSIONER CARR:
Oh, yes.
I-wasn't 4
sugges. ting I
would think that a
criteria for i
i 5
renewing their license is that they. certify they have j
(
G the program in place.
All I was doing was saying why j
7 bother to take a hard look at it ' then when you can R
look ni it as you go out and inspect the hospi t al?
9 MR.
TilOM p S ON :
I think, John, you may want i
l 30 1n ndd ibis in discussions with the regions We've.
l' shifted i<- a performance based program which rea]1y i
.12 menns t hou programs are going to rea))y vary by the 13 programs that h o r. p i t a l s have in place and the-skills
-J l1 of Ih-hosei inI people in developing ' programs So, 15 som.
of them in n. not have to do much work and some of 1G them may n..<d io do n loi of work.
It u t,.lohn, 3 thint 17 one of the ihings the regions were concerned of is lH vhai wo*
reall>
goint io be there when they IP implement ed these now programs and possibly not having' 20 a background and experience level with that type of 21 program.
22 John, do you have anything you went to add 23-on thato 21 MR. CLENN:
Yes.
I think probably the pilot ~
25 program will give us some valuable insit'his int o this, l
1.
J M:Al H.
GROSS
!?23 Rhode Island Avenue, N.h.
Washi ngt on, D.C.
20005 t202i 234-4433
I 2
\\
l 35
)
l 1
One thing we may find is that there are classes of 2
licensees who have trouble actually implementing the 3
rule and that it-o f f i c e review will serve a valuable 4
function there in making sure that they have correctly i
5 interpreted our intent.
It may be less resource G
intensive than doing it only through the inspection 7
process.
But I think we intend to throw the resources B
into the inspection area first, especially through the 9
contractor and ceriainiy ibrough our routine 10 inspot tion program as well.
Il CH \\ T R4 AN ZFCH:
Commissioner R o g e t r
12 COMMISS10NI:H R O G l: H S T et i
found ihe 1."
statement' of repot iing of errors in the 11 a dm i n i t. t i n i i nn of fractional
- doses, Section
'? 5. 3 4,
15 somewhnt confusing.
On pare 31 of the SECY, there's l f:
some d. t e na n t - ni t hi lasi paragraph of the page t hat i
17
.I r o n i 1,.
don't quite undetstand and I wonder if you l
10 rould e!araf> that a 1ittle bit.
There's a staiement, 19 "For any treatment
- fraction, the administered 1
20 fractional dose differs from the prescribed fractional 21 dose by more than 20 percent of the prescribed 2L fractional
- dose, t hat 's reportable."
And then, "For 23 any treatment fr6ction the administered fractional 24 dose is great er than twice or less than one-half the 25 presciib"d f t ac t i otial dose is another reportable l
l NrAl it. GROSS 1323 Rhode Island Avenue, N.h.
ha s,h i n y t on, II. C.
20005 (202' 234-4433
l i.
I 1
situation."
2 I
don't understand what's the difference 3
there between thcse situations that are being 4
described.
Why isn't it,iust 20 percent rather than 5
50 percent, greater than twice or less than half of 6
the fractional dose?
Do they apply t o different hinds 7
of adminis t rations or what?
8 MR.
THOMPSON:
We'))
let John Glenn try it i
9 fi rs t' If that doesn't
- work, we'll tr y the other 10
.Tohn.
j 11 MR. CLENN:
There are actually two d.i f f e'r e n t l '.
problena, that we were trying to addrest here One is I
]T wher e there i s.
an error in the delively of a
- s. ingle
].1 fraction which is outside the bounds.of what we
]n consider to be reasonnble.
T h a t ' r.
where the twiet or IC lesr ihn one half would come in.
That would be l
17 reportnble io ihe NHC pure]y on ihe mer ii >
of one j
18 a d tr i n i r.1 r a t i n n given on one day.
19
- Now, there's also the problem of when the 20 plan is written down incorrectly and there's going to 21 be an accumulation of errors in the f r a c t i on e, that are 1
22 being given.
So, let's say that it's not going to be 23 eff b.,
50 percent, but each of the fractions it's 24 going to be off by 20 percent.
It would be reportable 2 'i when the error ihat han accumulated in i e rm e.
of the t._
NEAL H.
GROSS 1323 Rhode lsland Avenue, N.W.
Washincton, D.C 20005 (202) 234-4433 I
i
.__________________a
37 1
dose delivered to what was-really prescribed initially 2-is equal to ten percent of the total dose to be 3
delivered --
4 COMMISSIONER ROGERS:
-Yes, I
understood 5
that.
But then I didn't understand the other two 6
differences.
Now, I don't want to take a lot of time-i 7
to pursue ibis right here because maybe everyone else 8
isn't int erest ed in it But I found it confusing and O
I just hope that someone who has to apply this does j
i I
10 understand what those differences are.
11 So, it looks to me like the same words are 12 describini. two di f f ereni kinds of fractional errors.
19 and 1 don't see what's different.
The language is all 14 the came.
" rot ony t reat ment frac 1 ion, the 3
15 administered fractional dose differed from the l
l 1G pren c s-i hei' fra<tinnal dose by more than 20 percent of 17 the pri scr ihr d fractional dose.
For any treatment l
18 fraction,"
same words, "t he administered fractional 19 dose. same words, is grenier than twice or less than 20 one-half the prescribed fractional dose."
21 COMMISSIONER CARR:
You can see the last 22 column.beenuso if you only report the more ones, you j
23 don't get the guy that didn't get enough treatment.
l
4 COMMISSIONER ROGERS:
Yes, but why not just 25 the less --
NEA1 R.
GROSS i
1323 Rhode Island Avenue, N.K.
Wanhingion, D.C.
20005 (202) 234-4433
.1 i
i 38
._ __J 1
COMMISSIONER CARR:
But now whether the 20 1
2 percent makes into more ihan 50 percent, I' don't know.
3 MR. BERNERO:
-- ' derive from the -- the one 4
is the total and one is the per treatment.
If you go
)
5 to --
G CilAIRMAN 7.E Cil :
Let's just one at a time 7
her e for ihe reporter, please.
8 All right.
Who is on?
1 9
If I
could. direct your j
10 attention to page '2R and 29 of the SEcY paper, you can-11 s e r-h n et ibe 20 percent timas two is used.
In the case j
l 12 of t he 20
- percent, that report g o e s.
to Jirensee 1 :;
ma%remont and quality assurance, s i n c r-t h a.t ' s a
11 warning level.
I 1~
e0MMiss10NFR ROGERS:
Okuy.
All ri gh t 10 MR. TELFORP:
At the 2 level in Tiem D there i
17 on ihe p :i r
)
i 18 roMMISSTONI'R ROGERS:
That goe: io ur 19 NR.
TELFORD:
that's the w a r n i n g---
20 thai's the alarm.
2]
COMMISSIONER ROGERS:
Oh, okay.
All right.
22 Ohny I see All-right.
It's a question of where is 23 it reported io.
Yn, al1 right.
I see the poini.
24-Y e s.,
it just wasn't clear to me in that pariicular 25 section.
I lJ' NEAl. R.
GROSS 132'1 Rhode Island Avenue, N.K.
h a t. h i n g i o n,
- 11. C.
20006 (2021 234-4433
o 39 1
On your benefit impact comparison, did you 2
consider what the possible benefit would be with' 3
respect to i'nsurance
- rates, medical. malpractice 4
insurance rat es of putting this in?
Would that be a 5
benefit?
O
. DOCTOR MORRIS:
We didn't consider it-as'far 7
'a s -
I'm' pretty sure we didn't consider it.
8 COMMISSIONER ROGERS:
I don't'know if there 9
woul d im an impact on thai or not, but you are 1ookiog 10 nl e <, s t s.
n n il you nre look.ing at benefits and the only, il quant i t at ive benefits we)),
I haven't seen any 12 q uan ' i t..t i v c b e n e f ; i o-exaelly in t h i t..
You don't know 13 how in asr en t h o s r-and then the e c o n on:l e bene fii 14 might li e as s o rn '
impnet
- on medical malprariire
!G insurnnee rate-If this were in effect, they might 1G chante 1 dcn't know, probably go up.
17
.CONMISSTONCR CARR:
Probably change if we 1H make ihem reporioble 19 COMMISSIONER ROGERS:
There might be some 20 effect.
.21 MR. HERNERO:
Well,. excuse me.
If I could 22 add, when we edge out of the direct nuclear costs'and 23 nuclear b enefi t s., we cet into things like this might 24 divert resources from other medical safety uses.
By 25 the same token, thrre could be favorable effects that NEAL R.
GROSS 13"3 Ithode Iv.1and Avenue, N.W Washingt on, D.C.
20005 (202) 234--4433
l l
40 I
I LJ 1
tha installation of better practices here can inntill i
2 betier practices in adjacent non-nuclear medicine.
l l
3 COMMISSIONER ROGERS:
Right.
i i
4 MR.
BERNERO:
And it.'s extreme]y difficu]t J
1 1
5 to quantify those at all and, of courae, to deal with l
J i
G them, they're outside our jurisdiction.
}
7' COMMISSIONER ROGERS:
It's really a
j 8
question, not a di rect ion, which-is:whether you looked 9
at i.t.
10 4p BPRNERO:
Yes 11 COMMISSIONER ROGERS:
But just on that 12 watt.o,.the langung in the SECY indicates t h n.t the
{
1 13 ef fi car > of the 1-roposed OA Program will be determined 11 through the pilot program.
Bui that word " efficacy"
- " ~ ~ '
15 i:
one ihot we had a 1ifile trouble with earlier, 1 I r, know in the. Tune ' f t f! SECY, t.h e
- t. t a f f rtnted that i
17 because of the low probability of misadministration, lu
<.nmething t h::! ' a referred to here repeatedly. n pilot 19 p t o g r nn: ray no' prove *he efficacy of the rulemaking.
i 20 Ti's just that the data is so meager.
2)
So.
is ibat still an appropriate word?
It l
22 came out or was disclaimed in an earlier version and 23 now it's back in there again.
1 l.
24 DOCTOR MORRIS:
I think we ma: he using it t
l l
25 in the laiter sense, I believe.
What I had in mind L
NEAl R.
GROSE 1323 Rhode Tsland Avenue. N.K b as hi nri on,
D.C.
- 2000T, (2001 231-1433
r' I
was that just the ability. for the licensees to-2 implement these measures and to feel like they were i
3 making progress in beefing up their program would be l
4 what would be tested in the pi)of program.
i 5
The idea that you could somehow see i n' any i
6 short-ranged time frame a reduction in the rates may 7
be somewhat optimistic and I'm not sure that that 8
could happen.
That may be the difference between the j
l 9
two usec of the word here I think it may take some J
10 time afier this rule would be in place before you.
11 could go barb and reassess the data and see whether 1:
i h, r -d u c t i <.i.
I I
13 COMMISSIONER ROGERS:
Really referring to 11 somethinc else, in a sense, in the use of that word, i
i l
1G Do sou expect that this petition for l
l 1G rul"mnkir.c thr' come from the Society nf Nuclear
]
17 Madicino th" A nu r i c a n College of Nuclear p h y t. i c i a n s,
i i
18 wi11 has e any erfeet on ihe proposed program?
10 DOCTOR MORRIS:
The standard that they're L0 developing?
21 COMMIESTONER ROGERS.
Well, there is now a 22 petition for rulemaking that was received last week, 23 Do you expert i hof i hai would have any impact on the 24 program or its reporting requirements?
I wouldn't think so.
Not ihe NEAI. R.
GROSS
!"2" Rhode Island Avenue.
N.W.
hashington, D.C.
20005
'202, 234 1133
.~
'l i
42 IJ l
QA rule.
No, I don't think it would impact it.
If we 2
proceed favorably, this is what I
call the FDA 3
petition, that the FDA authorizes.
4 COMMISSIONER ROGERS:
Yes, ri ght.
I 5
MR. BERNERO:
If we proceed in favor.of that' G
- position, there's a little more of their practice--
I 7
they have more flexibility.
In a sense, there's a
- i R
broader range for the OA' internal process io work for 9
- them.
B oi t h a t ' r.
a second ordei e f f e r i.,
7 would 10 thinh 1 don't see o direct link.
1]
COMMTSS10NER ROGERS:
Fine.
Thank you very 12 much.
13 C l!A l R M A N 7 1:r H :
All right.
Commissioner i
l <1 Cu ri ins' In COMMI S S I ONT:1f CURTISS:
Just one quich JG q u e r. ! i n n.
If your figure of 75 percent is in the 17 ballpark.
enuehly 75 percent of the events would be 1P prevented by this rule.
Do you have a feel for what 19 the ovornll done reduction'would be from this rule?-
20 DOCTOR MORRIS:
No.
The overdoses -- we've 21 got some experience from the past and I suppose we 22 could go back and calculate those doses that would 23 have been averted if we a r. s. u m e those events had not 24 occurred.
We have not done that.
But in general, our 25 feeling is that the variet y of situations is so large 1
L ;
NPA!. P.
GROSS I?2R Rhode Island Avenue, N.W Washington, D.C.
20000 (202T 234-4433 l
43 1
that it would be difficult to try to project into the l
2 future.
l 3
COMMISSIONER CARR:
Some are under doses.
4 MR.
BERNERO:
Yes.
I would like to just x
5 interject.
We've just gone through this process in 6
another arena.
It's very difficult in medical 7
admi n i s t rat i on to separate the good radiation from the 8
bad radiation from the missing radiation, the under 1
l 9
dese<
The figure of merit or demerit, you know, l
10 avrried dorr>
just breaks down.
It's very di f ficul t -
l 11 to use 12 COMNIss]ONTH CURTISS That'- a :l l ] have 1:
CII A T R4 A N Z E C il:
In the pilot p r o tt r a m that l
l 11 you desolopod, 1ow have you determined who wil) 1 parii< irate in this program?
Did y c; u go for i
1 F.
volunir< r-oi wlu. t did von do in that regard' 17 DOCTOP MORRIS.
Once the C o n,m i s s i o n decider i
}b i il IP(
I(> r k h l' d 19 CHATH4AN Z E Cil :
Yes Have you i hou ghi al out 20 that?
El DOCTOR MORRIS:
-- we will begin to contact 22 the various pot enti al volunteers There would be a 23 Federal Rerinter notice that w o u.1 d accompany ihe rule 24 that would describe the pilot program and ask for 25 voluntocra And aiso there would be anot her process we NEA1.
R.
GROSS
.I 3 :' M Rhode is1and Avenue, N.W.
Washington, D.C.
20005
/202's 234-4433
t 1
.44 I
.._ _i 1
would go through to make sure that we have a b a l aric e 2
of different kinds of licensees.
So,. there would be 3
two di fferent mixes in the pilot program.
We will be 4
making an effort to get volunteers t h r ou gh.T_!te Federal 5
Herister G
CHAlHMAN ZECH:
All right.
Thank you.
7 Well, unless there are any further questions R
f r.o m my colleagues, I would just like to thank the 9
staff for a
very
- useful, informative briefing.
10
- prankiy, l'r encouraged by the. progress that'has been.
1I made in thit very important rulemaking effort and I 12 c o muw n. ' tbe 1.1 a f f and ofher< who have au isted you in 13 cont ribut i t y to development of t his rule.
Il I
- not, that 1he sinff has worked very l i-
<: l o s e l : with the medical community and w'
appteciate 16 their rupport for this rule, recognizing t hat ihere 17 arr those who don't think it's necessaty, but at least
]H thes hate help d, l undersiand, in this development.
L 19 We has e iried to develop a performance based rule, 20 making it n reasonable rule.
I know that you're 21 developing this pilot program and you've put a lot of 22 efferi in+o this whole initiative.
i l
23 h% want a good rule.
But I think as much.as i
24 anything, we do recognize that the import ance of this 2 Fi rule it tr enhance public health and safety.
We'do
]
l I
L -
l l
NEAl. H.
GROSS 1323 Rhode Island Avenue.
N.W.
hashineton, II. C 20005 1
,202',
234-4433
_____.____________________._________________J
45 1
think there's room for improvement in spite of the 2
exce))ent record that we see.
I! u t in all human 3
endeavor, improvement is usually possible.
We expect 4
the medien] community to strive for improvement.
5 During my time on the Commission, I've had a 6
chance to visit a number of hospitals.
I've been 7
impressed by the hospitals I've visited, with their ft dedicalion to professionalism of the medical 9
community, those who are strivine to diagnose and-10 irent paiionte My observation is that Ihey are doing.
11 thir
- i. n o
very commendable manner and the rule l?
r e r t a i n :l y is not meant te intrude on t hat continued 11 fine performance of t he medical community.
11 Eu! the role is intended to see if we can't 15 make sone ' improvement and even a n k r-an e >. c e l l e n t IG rec.r d men better heenuse we're dealing wiIb human 17 liv"t and i t 's important that we and the medical
]H oirn u e j t y do what we ran to seet improvement J
19 believe i ha t wiih the medical community's co ni i nu r-20 dedication to the safety of their patients, that this 21 improvement is possible.
22 1
would a rs k my fellow C om m i s s,.i o n e r t.
to l
23 reflect the next few days on today's discussions and 24 the paper before us in SECY-89-171 and vot e when you 25 feel you are ready.
I NI: A L If. GIIO S!;
1323 I?hode Island Avenue, N.K.
hashington, D.C.
20005
( 2 0 2 234-4133
s l
4G I
.J 1
Before we let me ask my fellow q
j 2
Commissioners for any ' addi t ional comments before we 3
. conclude.
4 But before we - conclude the day,-
let me 5
congra t ulat e. Commissioner Carr on his selection by G
President Bush to be the Chairman of ' the Nuclear i
7 Regulat ory Commission and to relieve me on thr'Ist of
.q R
July.
3 know Commissioner Carr wi13 receive the-1 0
continued fine support. o f - t he Commirision ihat I've i
10 received and also the coniinued fine support of our.
)1 staff.
i i
12 So, C o rian i s c i o n e r
- Carr, you hate la y very 13 sincere congratulations and best wishes for your
)
1
~"
11 succe t.
at Chuirman of ihe Nuclear Regulatory 1~
C omm i e r. i m,
.1 C C OM"1 R M 10 N F'I' CAHH:
Than). you.
17 CHAIRMAN ZECH:
Are there any other comments 18 to mak<'
1i ihero are not, we thunk 3 o u' very much.
l 19 A r a i r,, we stand adjourned.
i 20 (hhereupon, at 2:57 p.m.,
the hearing was 2]
adjourned.)
22 I
23 24 25 i
i l
t NEAT F.
GROSS 1323 hhode Island Avenue.
N.W.
W a s: h i n e t o n.
D.C.
20005
'202' 231-4433 4
%..wv_______.__.__
- ah e
CERTIFICATE OF TRANSCRIBER This is to certify that the attached events of a meeting of the United States Nuclear Regulatory Comatission entitled:
j
. TITLE OF MEETING: BRIEFING ON PROPOSED RULE ON BASIC QUALITY l
ASSURANCE IN RADIATION THERAPY' PLACE OF MEETING: ROCKVILLE,.MARYLAtJ DATE OF MEETING:
JUNE 13,.1989 wer'e transcribed by me. I further certify that said. transcription is accurate and complete, to the best of.my ability, and that the transcript is a true and accurate record of the foregoing events.
au
..-,,[-
~)
Reporter's name:
Peter Lynch O
HEAL R. GROSS COURT Rf>0RTER$ AND TRANSCRl0ER$
1333 RMODE ISLAND AVENUE, N.W.
(202) 234-4433 WASHMGTON D.C.
20005 (202) 232 8600 M.
- 1 i
%e i
i PROPOSED AMENDMENT TO 10 CFR 35 l
l i
BASIC QUALITY ASSURANCE PROGRAM
]
l I
AND REPORTING REQUIREMENTS I
STAFF PRESENTATION TO THE COMMISSION JUNE 13, 1989 l
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OUTLINE OF BRIEFING BACKGROUND MISADMINISTRATION RATES REGULATORY OBJECTIVES
SUMMARY
OF AMENDMENTS TO PART 35 REGULATORY GUIDE MODIFICATIONS OF REPORTING AND.
j RECORDKEEPING REQUIREMENTS BENEFITS AND IMPACTS RECOMMENDATIONS l
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3 BACKGROUND l
PROPOSED MEDICAL CA RULEMAKING OF 1987 RESPONSE OF MEDICAL LICENSEES STAFF OPTIONS PAPER E RECOMMENDATIONS (SECY-88-156)
COMMISSION DECISION (SRM OF 7/12/88)
)
STAFF INTERACTION WITH INDUSTRY
)
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MISADMINISTRATION RATES
-. MISADMINISTRATION REPORTED To'NRC J
(1980-1988)
- 88 THERAPY RELATED EVENTS
" 3200 DIAGNOSTIC RELATED EVENTS ESTIMATED MISADMINISTRATION RATE - ALL-J LICENSEES
- 30 THERAPY.AND.1200 DIAG. EVENTS /YR s.
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REGU!.ATORY OBJECTIVES
- REDUCE RATE OF ERRORS IN MEDICAL USE OF
{
BYPRODUCT MATERIAL
- ESTABLISH GENERAL REQUIREMENT FOR BASIC I
QUALITY ASSURANCE PROGRAMS FOR MEDICAL USE
- PROVIDE GUIDANCE ON QA PROGRAM. ELEMENTS
{
i ACCEPTABLE TO THE NRC 1
- IMPROVE DETECTION AND CORRECTION OF l
BREAKDOWN IN QA IN MEDICAL USE f i
SUMMARY
OF NEW SECTION 35,35
. REQUIRES IMPLEMENTATION OF NRC APPROVED-BASIC QA PROGRAM SPECIFIES OBJECTIVES'0F CA PROGRAM' REQUIRES REGULAR PROGRAM AUDITS TO VERIFY COMPLIANCE REQUIRES EVALUATION OF AUDITS BY-LICENSEE MANAGEMENT.
REQUIRES PROMPT MODIFICATION OF PROGRAM TO PREVENT RECURRENCE OF ERRORS 4
5
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i SPECIFIC OBJECTIVES 0F MEDICAL 0A PROGRAM i.
i T0 ENSURE THAT
- ANY MEDICAL USE'IS INDICATED FOR' PATIENT'S MEDICAL CONDITION.
- PRESCRIPTIONS.OR DIAGNOSTIC REFERRALS l
ARE DOCUMENTED 8 UNDERSTOOD.--
- MEDICAL USE IS IN ACC1RDANCE WITH THE
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PRESCRIPTION OR THE DIAGNOSTIC REFERRAL AND CLINICAL F70CEDURES MANUAL-1
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SPECIFIC 0BJECTIVES 0F MEDICAL QA PROGRAM
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i IMPLEMENTATION OF 35.35 i
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THE EFFECTIVE DATE IS 6 MONTHS AFTER PUBLICATION OF FINAL AMENDMENT.
- BY THE EFFECTIVE DATE, SUBMIT WRITTEN CERTIFICATION THAT A PROGRAM HAS BEEN IMPLEMENTED.
SUBMIT PROGRAM TO REGIONAL OFFICES AT TIME OF LICENSE RENEWAL.
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REGULATORY GUIDE PROVIDES AN ACCEPTABLE WAY TO MEET THE REQUIREMENTS IN PROPOSED SECTION 35.35 FOR BASIC MEDICAL 0A PROGRAM, ADDRESSES EACH OF THE PERFORMANCE OBJECTIVES OF THE QA PROGRAM REQUIRED BY SECTION 35.35.
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,a REGULATORY GUIDE
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PROVIDES GUIDANCE FOR LICENSEE TO DEVELOP BASIC QA PROGRAM.
- WILL BE EVALUATED THROUGH PILOT I
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- STRUCTURE'REV1 SED TO ACCOUNTLFOR-REPLACING SINGLE TERM
" MISADMINISTRATION" WITH " THERAPY EVENTS" AND " DIAGNOSTIC EVENTS."
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- CONSIDERED' EFFECTIVENESS OF SPECIFIC
}1 PROVISIONS OF REG. GUIDE lN PREVENTING THESE EVENTS.
- ANALYSIS SUGGESTS APPROXIMATELY 75% OF-l EVENTS COULD HAVE BEEN PREVENTED BY basic QA.
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i DENEFITS PROPOSED AMENDMENTS AND R.G. HAVE-POTENTIAL TO REDUCE LIKELIHOOD OF l
MISADMINISTRATION DUE TO SIMPLE HUMAN ERROR.
ACTUAL REDUCTION IN ERROR RATE DEPENDENT ON EFFECTIVENESS OF QA MEASURES AND THEIR-IMPLEMENTATION.
INCREASE IN PATIENT SAFETY DIFFICULT TO QUANTIFY.
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BENEFITS REVISED REPORTING AND RECORDKEEPING SHOULD PROVIDE AN IMPROVED BASIS FOR INSPECTION AND ENFORCEMENT.
6 17
F 2_, c,g 6-IMPACTS
' * : ANNUAL COSTS OF DEVELOPMENT ~AND
- IMPLEMENTATION OF BASIC.0A PROGRAM DEPEND ON' TYPE.0F! LICENSEE.
- DEPEND ON. DEGREE T0-WHICH:L'ICENSEE ALREADY lMPLEMENTS GOOD BASIC 0A' PRACTICES.-
- RANGE FROM ~ $100 TO + $4000 PER' LICENSEE.
- FOR ALL 7500 LICENSEES ~ $4M.
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1 IMPACTS l
1 INCREASED COSTS OF REPORTING &
l RECORDKEEPING REQUIREMENTS
- TOTAL FOR 7500 LICENSEES
$270,000/ YEAR
$344,000/ YEAR
- FOR AVG. LICENSEE
$36/ YEAR -+ $46/ YEAR l
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..1 BENEFIT-IMPACT COMPARISON-J UNCERTAINTIES IN QUANTIFYING BENEFITS AND IMPACTS.
STAFF UNABLE TO DETERMINE WHETHER INCREASES IN PATIENT, SAFETY WILL OUTWEIGH ECONOMIC AND'0THER IMPACTS.
PUBLIC COMMENT PROCESS'AND PILOT PROGRAM PROVIDE OPPORTUNITY TO LEARN MORE ABOUT BENEFIT-IMPACT BALANCE.
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RECOMMENDATIONS THAT THE COMMISSION APPROVE
- PUBLICATION OF PROPOSED REVISION TO PART 35.
- PUBLICATION OF REGULATORY GUIDE.
- STAFF PLANS TO CONDUCT PILOT. PROGRAMS l
l 21
,. M NNh88hWWWNWWWWWWWWWWWWWWWWWWWWWWgggyggg g g gi TP.ANSMITTAL TO:
__ Document Control Desk, 016 Phillips t
j ADVANCED COPY TO:
The Public Document Room dh 8[N DATC:
I FROM:
SECY Correspondence & Records Branch Attached are copies of a Connission meeting transcript and related meeting
(
E document (s). They are being forwarded for entry on the Daily Accession List and' l
placement in the Public Document Room. No'other distribution is requested or
. required..
Meeting
Title:
b2A Ar;"M M_A b2 S; hS_ R& Awe =_ S.h l '. &
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Io // 3 /7 9 -
Open X
Closed I,
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Item Description *:
Copies l l Advanced DCS i
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- 1. TRANSCRIPT
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- PDR is advanced one copy of each document, two of e'ach SECY paper.
3 C&R Branch files the original transcript, with attachments, without SECY papers.
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