APPENDIX B

NUCLEAR MEDICINE INSPECTION FIELD NOTES* Region -

Inspection Report No. License No. 08 -o/ 738-02

Docket No. 0.30- o

Licensee Contact - . . - . . - . ." . Last Amendment No. Date of Amendment

Priority :

Program Codes: , (i/2110 - Bmad Scope ( ) 02120 - Limited ( ) 02121 - Custom ( 1 02200 - Private Practice - Limited ( ) 02209 - In Vivo ( ) 02201 - Private Practice - custom ( ) 02210 - Eye Applicator ( ) 02220 - Nuclear Medical Van ( ) 02400 - Veterinary ( ) 02410 - In vitm ( ) 02500 - Pharmacy ( ) Other -

Date of Last Inspection 2 / 7 6

Oate of This Inspection

Type of Inspection: ( 1 nounced ( A u t i n e

(hnannounced ( ) Special

( 1 Ini t ia l 9 Reinspection

Next Inspection Date. ( d m 1 ( 1 Reduced ( ) Extended S m r y of Findjngs and Action:

Inspector: Date

7

Approved: Date

* - ! All areas indicated i n f i e ld notes are not m q u i n d to be add~ssssd during each inspection.

Appendix 8, 87100

e. V i s i t i n g Authr zed User A d - ( 1 W/A

(1) Has w r i t t e n permission [35.27(a)(1)] (2) Copy o f v i s i t o r ' s l icense on f i l e

O Y O N

135.27(a)(2)1 (3) Performs only those procedures authorized

( ) Y O N

on v i s i t o r ' s l icense [35.27(a)(3)] . (4) Uses mater ia l under l icensee's l icense f o r

O Y O W

s i x t y days per year o r less [35.27(b)] (5) Records maintained 3 years a f t e r l a s t

O Y O N

v i s i t [35.27(c)] ( ) Y O N

Remarks.

f . Mobile Nuclear Medicine Service ( $-%/A

(1) Licensee uses mobile nuclear medicine services E35.293

(2) Licensee operates mobile nuclear medicine O Y O W

services l35.29, 35.803 ( ) Y O N

Remarks.

2. INSPECTION HISTORY N/A - I n i t i a l inspect ion

a. Last inspect ion conducted on

b. V io la t ions o r deviat ions uer [ @ O N

c. Response l e t t e r o r 591 dated

d. V io la t f ons froin Previous Inspectton

Requirement V io la t ionL - 1 Corrective Act ion Taken @N> Status , I -

4. ' INTERNAL AUDITS OR I ?ECTIONS

a. Audits or inspections are conducted

(1) Audits conducted by Cf 3

(2) Frequency

b. Audits are required by license condition c. Records maintained

( ( N I ( 4 ' Y ( 1 N

Remarks. ~ / / - / z / Y f

5. TRAINING, RETRAINING, AND INSTRUCTIONS TO WORKERS

a. Instructions t o workers per 110 CFR 19.121

Remarks. @x> b. Training program required [UC] (4'Y ( N ( N / A

(1) Training program implemented (2) Retraining program required (3) Retraining program implemented (4) Records maintained

Remarks. /

c. Supewision of individuals by authorized user i n accordance wi th 135.251 d( )~

Remarks.

bpendix B, 87180 B-5 Issue Dak: 0m9/91

, - 7 d. Survey instruments

Approriate operable survey instruments possessed per [35.120,220,320,420] or available per [35.520] Calibration ~erformed as reauired

(4 ( 1 N ) N N L . .

in [35.51] Records maintained [35.51(d)]

@ Y O N

Proper operation WON

per [35.51(c)] ( ) Y O N

e. Syringes containing RAM properly labeled and shielded unless contr indi ated pe 135.60

~ - ~ + a c7J~ysLPLf-wr /-Lh f. Vials ontalning RAM properly labeled and

shielded per C35.61 bi~" / 6 4 (WON Remarks. &.,tiy -A/ J o e - hri! u r J s7..y ~ - 4 . b ~

r

7. RADIOLOGICAL PROTECTION PROCEDURES

a. Radioactive materials used i n accordance w i t h current procedures [VC] (dy ( N

Remarks. F b u ,e c i t i e J d;/ j

4- al%,h,2+cf3 ,,%c/G- m - i - c l e /A/Tic/x pr* h PC/" ,?

+-.= d o s e .

Issue Date: 0=9/91 Mpendix B, 87109 i-

l-LJ -6 - t J J;;.- i /M- wG Y1 d&/ !

f. Leak tes t s and inventory

(1) Leak tes t s performed on sealed sources and brachytherapy sources per [35.59(b)]

1 I (2) Inventory o f sealed sources and brachy- \ therapy sources per [35.59(9)]

(3) Leak t e s t s records i n microcuries Y ( 1 N ( W O N

(4) Leak test / inventory records signed by RSO (9 ( ) N (5) Records maintained o f leak t e s t s and

inventor ies f o r 5 years ( > Y O N /vl Remarks.

l * a k p,u,,a.z +Y $JY aJ # / Fnfuai.% , S d c,rreJ

dZP i q - ~ % I ( ~ F ' \ D ' C//phcL dlC fL.e-4

A / ( f ~ s - l A 5 L* odd-

9. RECEIPT AND TRANSFER OF RADIOACTIVE HATERIAL f l"-r Y'/' /kc,. t7 6 rcce,

( 1 N/A ,t ;% 41

a. Describe how packages are received and by whom: Or .r#

0kJrbcJ pCLy~ Jef7 -Ca:YL/+ s U c c P y f J ,+

JC QJj / j%.&~hn An+ . 7 7 7 - 5 7 /

5-c / 0 Y j , _ C p r ~ F e r <+.a+- ;t! + YVI-sc- J CY/-J*T)

- - . Records o f surveys and. rece ip t / t fans fe r ~ a i n t a i ned per [20.401(b) and 30.513

Remarks.

Appendix 8, 87100 B-9 Issue Date: QY19/91

e. Brachytherapy . m e s inventor ied per E35.4061 (4 ( ) N f . Brachytherapy source storage area surveyed

quar te r l y and record signed by RSO [35.59(h)3 g. Records maintained

( ) Y O N . O Y O N

Remarks.

13. PERSONNEL RADIATION PROTECTION - EXTERNAL

J CPIIY-Q + P Y

a. Fi lm o r TLD supp l ie r d.i ,nrw ~ ' p r , , r e r s , c w t L & p Frequency 11/I /?h i b a

5 - f lWoU J b. Supplier i s NVLAP - approved V r a +u 4 c. Reports reviewed by f l s b / C L , , ~ ' - Frequency bb P Q C P , ' ~ .

bdi_ NRC inspector nv iewed personnel m n i o r ing records f o r

per iod 1 q Y i t o

pGr~d1.6 I e. NRC forms o r equivalent

(1) NRC-4: ( ) Y ( ) N y F Complete: (2) NRC-5: ( ) Y ( ) N N ( Complete:

o Y O H O N / A

[20.401(a)] o Y O N O N / A

f. Listmaximumexposures ( m i l l i r e m ) : 3r-37 ~~~*~~ 2'' ' * f i u a L f ~ i r L ~ ~ , ~ ~ ~ ~ ~ ~ ~ ~

g. Licensee has implemented an AIARA program 135.201 ( ) Y O N

Remarks. i =A e v oS-5 sL/J ~ r * A r ; AA;L

7Cb A... oi e h/ e,yp.5--<~ u r r . go+ r o b j o r r ~ r y e

- , us= L = .i.d o /.dl n - f i OW /X i- I C+ 742 + G ~ c o r $+-=++-xA O - +A do ri le A, pFjr.

WYI/J B - e w - d ~ a/ -A+ h,hz$ 6 f i G a c A + a , ~ . - ~ ~

. .

14. PERSONNEL RADIATION PROTECTION - INTERNAL '. < ) n/A

a. Potent ia l f o r exposure o f ind iv idua ls to airborne RAM e x i s t s

b. b n i t o r i n g f o r a i rborne r a d i o a c t i v i t y conducted (4~ ( 1 H

[20.201(b) to m e t 20.183, 35.90, and 35.2053 (3/V ( ) W

b p e n d i x B, 8nOO B-U Issue Dab: 02/19/91 I I I

16. NOTIFICATION AH0 REP. .iS

a. Licensee i n compliance w i t h [19.131 dr (reports t o ind iv iduals)

b. Licensee i n compliance w i t h 120.4021 . o Y O N O H / A

( t h e f t or loss) '" ov'J ( ) Y ( ) H (<Hone c. Licensee i n compliance w i t h [20.401] & .

(incidents) wFed ( Y ( N one d. Licensee i n compliance w i t h [20.405]

(overexposures) A ~ O 4 ( Y ( N ( h o n e t #*#J

Remarks. 7

I L"s i - i r7 i rcJ + A h i r , i a/pi7bf~7h I

17. MISADMINISTRATIONS

a. Hisadministrat ions have occurred O Y ( & N

(1) Diagnostic - ypbJ (2) Therapeutic

O Y O N O Y O N

b. Licensee i n coml iance with r e ~ o r t i n a , I - therapeutic mi.adainistrations' ,,,,,, 7h C35.33(a),(b)l

7L/ Licensee i n compliance w i t h repor t ing diagnostic misadministrat ionr, i f required [35.33(c)l . - - ~ p p r o p r i a t e act ion taken to prevent recurrence Records maintained [35.33(d)]

Remarks.

O Y O N O Y O N O Y O N

Appendix 0, 87U0 Issue Date: 8Y19/91

f. Licensee makes :urn shipments of radiopharmacy doses l'JL- o ' f o N o N / A

(1) 1f YES, licensee assumes responsiblity of a1 1 shipper requirements

(2) If NO, describe arrangements made between O Y O N

1 i censee and 'radiopharmacy as to perf ofmance of shipper responsibilities:

20. RECORDKEEPING FOR DECOMMISSIONING

a. Records of information important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location unti 1 license termination [30.35(9)]

b. Records include all information outlined in O Y O N

[30.35(g)I O Y O N

Remarks.

21. INDEPENDENT HEASUREHEKTS

a. S u w e y fnstrunent used

b. NRC Serial NO. LL 6. s s ~ r c. Last date of cal5bration 5-6- 4 ('

d. Inspector's measurements were collpared to licensee's

e. Describe the type and results of w a s u ~ n t s : ( 4 0 H

< s h L c i a ko** / r f, Z I

C L ~ , / - fksr( ,L. 4. &- /&f LJ. ec,A- ,~ /~ :A, fL. ~ u v r - r ~ - d .( 4 :?

A F [ P RW ? / I= / w ~ f i r / 1 - en? 7 0 3 7 bpendix B, 8600 B-15 ISSW ate: QYPS/~I

q.!** 444 , 'i(/+T fl ++e,

25. PERFORMNCE EVALUAT I FACTORS

Licensee (name &

. locat ion)

a. Lack o f senior management involvement w i t h the rad ia t i on safety program and/or Radiation Safety O f f i c e r (RSO) oversight > Y C &

b. RSO too busy w i th other assignments O Y t d

c. I n s u f f i c i e n t s t a f f i n g O Y ( 4 '

d. Radiation Safety C m i t t e e f a i l s t o meet o r funct ions inadequately

e. Inadequate consul t ing services o r inadequate audi ts

Remarks (consider above assessment and/or other per t inen t PEFs):

E;cQ/ /c f /77"

i

Regional follow-up on above PEFs c i ta t ions :

Mpendix B, 87100 8-17 Isrug Dab: QYa9/9I

HEALTH PHYSICS OFFICE RMC BRANCH

RAD WASTE STATUS FOURTH QUARTER - 1990

I. Radioact ive aqueous waste r e l e a s e t o s a n i t a r y sewage - Fourth Quar t e r - 1990

a . Act iv i ty r e l eased : Q u a r t e r Wash S inks Year t o Date % of Annual Limit

(1 ) H-3 37.676 m C i 0.011 m C i 252.582 m C i 5 .1 % (2) 14-C 1 .A59 m C i 0.002 mCi 7.599 m C i 0.8 % (3 ) Mixed(al1 o t h e r s ) 13.982 mCi 25.693 m C i 198.127 m C i 19.8 % ( 4 ) T c t a l 53.117 mCi 25.706 m C i 458.308 m C i

b. Volume re leased: Q u a r t e r Year t o Date

To ta l 1 ,584.75 L i t e r s 6,552.15 L i t e r s

11. Local d i sposa l s o l i d r a d i o a c t i v e waste - Fourth Quar ter 1990

Q u a r t e r Year t o Date

a . Sol id < 8.5 days T 1 /2 29 Bags b. Needle Boxes 31 Boxes c. Sol id < 65 days T 1 /2 24 Drums d. Bio logica l Waste 0 D r u m s

165 Bags 113 Boxes

56 Drums 6 Drums

111. Radioactive Waste Shipments - Fourth Quar ter 1990

Quar t e r Year t o Date

a. Sol id > 65 days T 112 9 D r u m s 37 Drums b. Organic Solvents 3 Drums \ 7 Drums c. S c i n t i l l a t i o n Vials 15 Drums I

\ 67 Drums d. Biological Waste 0 Drums

\\

0 Drums (55 g a l over pack)

. IV. Radioactive Waste i n S to rage (Bldg 516 & 149A of Forest Glen Sect ion , kiRMC) w a i t i n g d isposa l - Fourth Q u a r t e r 1990

I a . S c i n t i l l a t i o n Vials 0 Drums b . Organic Solvents 5 g a l . Containers 2 Containers c . Solid > 65 days T 1/2 1, 2 Drums d . Sol id < 65 days T 1/2 125 Drums e . Sol id < 8 . 5 Days T 1/2 (approx 4 cu Ft/Bag) 83 Bag3 f . Biological ( f o r shipprnent) 30 g a l Drbs 0 Drums g. Biological (Local d i s p o s a l ) 55 g a l Drums

\ 22 Drums

h. Needle Boxes 30 Boxes \

V . Contaminated Laundry he ld f o r decay 1 \ EL. Crint~~xJninzted Ls,undrp in s t o r a g e I,

b . Decayed ~ a u a d r y processed t h i s quarter : c. Dec-syed Lzandry processed t h i s year

i 3 Bags 12 Bags 29 Bags

ASSAY OF 3M MODLE 6 D 6 C - C A CES.~-~!$ SOURGE. , ,- AuGu.s:T,~; 16,. . . . t . 9 8 9 , D E C A Y E ~ " ~ ~ FEBRUARY' 1 9 9 0

NOM I N A L SER I A L ASSAY mg-ra-equ Aver;ya;l.,.:. ,.. Value.: used*. rng-ra-equ # 8 / 8 9 - - - - - - 2 / 9 0 on , 2 / 9 0 i n ovo'ids

" M I N I - O V O I D S = NO F I L T R A T I O N ; A L L OTHERS = ( - 6 % ) S E L F ABSORBTION VALUES T A K E N FROM SHARMA e t . A L . & J U D i T H S T I T T K A A S e t . A L . , R A D I A T i O N ONCOLOGY B I O P H Y S I C S , VOL I I , P 1 3 1 7 - i 3 2 1 .

CYRUS MOAZED PhD C H I E F P H Y S I C I S T DEPT. OF RADIOLOGY

HSHL-HP I Appl ica t ion f o r Use o f ~ a d i b a c t i v e Mater ia l 1

a. P r i n c i p a l User

b . I n v e s t i g a t o r & Auth# ( I f d i f f e r e n t than ( a . ]

e. Radioisotope

f . T i t l e o f P r o j e c t :

Telephone Number Author iza t ion Number

c. Tra inee & Auth# d. Technician & Auth#

Physical/Chemical form Maximum Quanti ty t o be used p e r Experiment i n m i l l i c u r i e s

(mCi) !

Maximum Quan t i ty t o be used f o r E n t i r e P r o j e c t ( i f known) i n m i l l i c u r i e s (mCi)

. i so tope t r a v e l

FORM BA AUG so 2496 PREVIOUS EDI+IBNB WILL BE USED

k. Labelling and Transport of Radioactive Material

A l l r ad ioac t ive so lu t ions , t i s sues , animals and waste w i l l be iden t i f ied by proper l abe l , i n accordance with Health Physics Condition No. 4. Transport of rad ioac t ive material between authorized work areas and waste disposal s i t e s w i l l be conducted i n a manner t h a t precludes the spread of contamination and inadvertent exposure t o non-participating personnel.

m. Disposition of Animals n Not Applicable

1. Laboratory Animal Usage

Species

Animals w i l l be sacr i f iced and carcasses w i l l be disposed of a s rad ioac t ive waste.

Other (Specify) I

Bldg# Room#

0. Isotope Storage Location

n. Isotope Ut i l i za t ion Locations -

Building #

Room #

Max. Amt (mCi)

. Building # Room # Max. hit. (mCi)

I I I

p. Isotope Waste Storage Locations i

(1) Biological: Bldg# Room#

(2) A l l o ther : Bldg# Room#

A l l radioact ive waste w i l l be transfered t o t he Health Physics co l lec t ion point, WRAMC (Bldg 2 ( W F ) - loading dock)(1330 t o 1430) Wednesday of each week.

A l l radioact ive waste w i l l be transfered t o the Health Physics co l l ec t ion point, WRAIR (Bldg 40 - Room B079) Open Monday, Wednesday, 6 Friday I 1030 t o 1130.

Location 1

A l l radioact ive waste w i l l be transfered t o t he Health Physics co l lec t ion I point , WRAIR (Forest Glen Section) every Wednesday afternoon.

Location 3 Location 2 Location 4

q . Radioactive Waste Disposal

A l l radioact ive waste w i l l be transfered t o Health Physics Office i n accordance with Health Physics Condition No. 4 .

r. Room Survey

A l l room surveys w i l l be conducted i n accordance with Health Physics Condition No. 2 .

s. Personnel Dosimetry

Whole ~ o d ~ n Wrist Badge n TLD Ring

I w i l l be requested i n accordance with Health Phys ic~~Condi t ion No. 1. Assigned dosimetry monitors w i l l be worn by a l l par t ic ipa t ing personnel.

t. Are there any s ign i f i can t non-radiation personnel hazards associated with experiments; - (Biological , Explosive, Toxic substances, High In t ens i ty Optical .

sources, Microwaves, or E lec t r i ca l ) i t h a t would e f f e c t Health Physics personnel during there rout ine inspections of these areas .

Yes (Please specify)

The Research Protocol enumerated above and on the previous pages i s designed t o ensure t h a t occupational radiat ion exposures and re lease of radioact ive eff luents t o t h e environment w i l l be "as low as rea onably achievable" [ A M ) during a l l phases of t he research procedure.

I

Signature Date

APPENDIX B

t

NUCLLkR MEDICINE INSPECTION FIELD NOTE: Region _1_

Inspection Report Ho. License No,

Licensee (name and addrtss) Docket NO. - '46875-

Licensee Contact Telephone .Uo.

Last Awndment Ho. Date of h n d # n t

Priori ty : /

Program Codes: /'

( 4 2 1 1 0 - Eroad Scope ( ) 02121 - Custom ( ) 02209 - :n Vivo ( ) 02210 - Eye Applicator ( ) 02400 - Ycterinary ( ) 02500 - Pharrrrcy

) 02120 - Umitea ) 02200 - Privatr! Practice - Lfaitcd ) 02201 - Privat, Practice - Custm ) 02220 - Nuclear Medical Van 02410 - In V i t x b mher " 3520

Date of Last inspect!:^

Date of This Inspectim 3' //, /~, /?h"-92

Type of Inspection: ( ) Announced (/fUmnaumced (4 Routine ( ) Speciav. ( ) In i t i a l ( ) Reinsocction

Next Inspection Date. g - 7 3 ( f i~ l ( ) Reduced ( ) Extended

Sumary of Findings ~ ? d Action:

vioiations, Clear 591 or l e t t r r itsma 591 or let-r issued

( ) k t f o n on Previous Vlolatlons

Inspector: ht?~

Approved: D8t.a

* All areas indicataa i n f i e ld n o a s are not rsquitod *a k addmssd

during eacn i nrpectlon.

4. IHTE'iHAL AUDITS OR ZHSPECTIONS

a. Audits or insceetlons are conducted

(2) Frequenci

b. Audits are required by lfcense conditfon c . Records maintained

' Remarks. - ,u+ ,~~~d m d ( . ~ A ~ L J I * ~ J U ~ D ~ L-4) /Onl 0*~4 L ~ J . LA& ujd'7 - jA,M't.( MS - fl=lv/lKL- i /

5. TRAINING. RFTM:r;lHG. AND INSTRUCTTONS TO WRKERS

a. Inrtructions to wrkers per CFR 19-12] (//Y ( N ,&(- ,4,.q, ; hm /+MA l d ~ f ' ~ e n . 5 7 ) / ! ~ ~ ( z w s 7?06S&bS$ {AW5 # & a x

Remarks. A Z S W L ~ L 4 5 : f l u s 7 -2-

4 ,.f 2 J+y ( o ~ l / ) E G ~ Y F ~ ~ ~ p? sr*p m g

omf~ G R J ~ ~ ( : k rr//NA, Aera/kNJFR { j l ~ w &P&

b. Training pmgran rsquirea [ L f C l ( ' 6 f O H O W A

(1) Training progrm fwicllented (2) Retraining program required (3) Retraining pro raa i .p iwnQd f (4) RKO- main- ned

;i& "GZ Remarks. prr -a : $& GJ VP 5 r ? ~ / ~ d ~ 3 z 7 ~ . c a , . ~ ~ ~ ~ I

Wd 0PW5 R W 5 +,r@ $F.zt% { r d ~ y

c. Supervisicn of lndfviduafs by 8lrthDriud uur in accorunce with [35.25] ( 4' y < ) H

Remarks. ,- n ; - 1 d ~ e ,,J; ti& fu ;~~/ y re,- k, ehScr,-c :401/

pkiyk-nye i &I; ,,*&; 2) f i L( i,,uL, iqa+ , ii L(gLciu c: I&-, . cth;! 3 ' I @ L.L@$OI-~/ ' - i pi-< i :2z

(7 ',& "Q r- ci?e.,- J i /

B-f Xrsuc Mtc:

d. Survey instrtwents

Appror; ate operable survey instttments possessed per [35.120,220,320,4201 or avatiable per t35.5203 Calibration perfomd as n q u i n d i n (35.513 Recorns maintained [35.Sl(d)l Proper operation cheeked w i t h check SOU- per [3S.Sl(c)]

Remarks. .T

/ ! ! , , , ~i) I ; kl rs. dq, ~ f s i floon,liy ;> ; ; - + t, @i. ,J # y/b,rc: kfse,

LF j a g + * r.hcv..&s - P, ; . ! ' '" I A4 1 3 ~ - jm; i,.b,y 1 - I + i n g + i n t ~ , ~ ~ f i Lr .e , ,

c ~ ~ + ~ : ; , ~ 6 ~~1 , i j . [ 7 ~ - n / I e '2 J-C i9ci,t L e $ ~ f ~ m c ~ / c . ? e o ~

e. Syringes cxtaining RAn properly labeled and shielded uniess contraindicared per 135.603 (/(y ( 1 N

f . Vials contzining RlVI properly labeled md shielded per 135.613 (4 ( ) N

Remarks .- 5 ~ $ p ; ~ i ~ ? 865 *g p -# f?fPPA,d& A d /*ITF~T-~N& R /Q Z

y # + b L y / ~ h r c / s , ' ~HCGAJ 1 3 4 ~ ~ ~ & f l s 5n-b- A*~z-

7. RADIOLOG1 CAL P40TECTIOH PROCEDURES

a. Radiorctfve n tcr ia l s used i n ~cED~~UKI dm. current ~ x c e d u r e s [YC]

Rwrks.

Leak

(1)

(2)

tests anc Inventory

Leak tests perfomed on sealed sources ana brachytrcrapy sources per [35.59(b)] Inventory of sealed sources and brachy- therapy sources per [35:59(g)] Leak t e s t s records i n rrcrocurSes Leak test/inventQry rccords signed by RM) Records aaintained of leak tests urd inventories for 5 YerM

(4'~ ( 1 H ( Y O N $ ( Y O N

Remarks.

g. RECEIPT AND TRANSFER OF RADIOACTIVE HATERIAL

a. Describe hew packages are received and by ( 1 WA $id. ,%A : c G - 4 - ~47.4~ Af.. ICb ‘+AT s+ -

'=&.z& + d e B P & ~ + w u 6 - y: i l &&-

(1 k~il.~<jj<> L,r. <?,y~, ,~ . t . i t v <

rc. t-k ' 5k.v 6F- r :~~ whwc 8 1 ,CCL, 5 kitl c b ~ 2 + ~ , 2 4 ~ , fl.

b. Opening peceaures established f o l l d [20.205(d> 3 - c. Incoming packages wipea per CZ~.205(bIl

d. Incoming packages surveyed per [20.205(c)l c. Transferis) perfomd Per E30.411 f. Recorus of suweys and rtceipt/transfer

u in t a inc t per [20.401(b) Md 30.513 & y o n

. B ~ ~ ~ . , ~ ~ ~ ~ ~ ~ ~ sour. . inventoried per 135-4062 y o n

f. Brachythsrapy source stnrage area survey" and -0rd sitJn.6 4 RSO [35.59(''')1 :& i f i g. Records maintai aed

,. '

F d i 4 , :pcM. fo12 -5c bi r ( C j i .ic'i$? "TC;( McMgar T L i Q

13.

c. Reports revieed by

e. HRC forms or equivalent

(1) NRC-4: (p ( ) N (2) NRC-5: ( ( ) Colplete:

L20.401:a)l -1 - il/10 VLf i- t ~ i v - 1 - 1

f . ~ i s t maxiam exposures (mi11 f r-1: ,

;3 L; r 3 &! p, 4-k : j 7'1 ,<v<+-/ r 7 "' Me ' c ; ~ I o : ~cj j~,~d ;r g. Licensee has 'lW&ientld an Auu pmgran ( ) Y O N ,' , $ I :

[35.201

Remarks. I - ~,,2~+;gnf;~1 ci.+ fliiqg# I 7 u .s-<c2;;'cP 2-5 - I ~ d ) 2 8 2-.5c-e* EX#ed+,;Y A&

n i; ,.?Lr ,,-:d ; j C e . 7 , . , i . . - r ; - i 5 i I Lc'/ 3 ~5 h ' 1 . - ~ ~ t ~ i , , . ~ .. . -. ~ (ait i~ l i ter I ~ L . C il S<

C' La-y , 3C) C(C k> 1

s a c d k-tpr .T'F~C;~C. &qj17r, &&( ' j 2i;Aid.

14.

( L 3 / v o n .?

. ,,>,.2n , i~; .y 1 ~ . , ~ , i GPl~ii. i \ i , i i r z ;o ~ c r m G I,-;, Inr oi l i&,, 11,{

8 - 2 lssw oats: f 91 I\ppcndix 8, BnQo

t j

16. NOTIFICATIOH AND E E P t , , , S

Licensee in comliance with [19.131 (reports to individuais) "k- t '

(theft or loss ) 1 Licensee in compliance with 120.4 21

blcensee in compi iance w i t h [20.4033 (incidents) LIccnsee in compliance with [20.405] (overcxposurcs)

Remarks.

, #'4 k h+f ~ .HJ / l i i )

'".*x& * 5 &,,J ,/'.-,A

17. UISADE1NISTRATICL;S

a. H i sadmi ni strations have occurred ,-

(1) Oiagnos=lc (2) Therapeutic

Appendix 8,'8m0

f . Licensee makes r im sh fpwnt s of radiopharmacy doses 6 1 Y ( 1 n (/LA

(1) I f YES, 1 icensee assuws n s p o n s i b l i t y of a l l shipper r e q u i m e n t s

(2) If NO, descr ibr rttangcwnts .ade between O Y O N

l icensee and kadiophamacy as t o perfo of shipper ~ s p 0 n s i b i 1 ities:

20. RECDRDKEEPING FOR 9ECOI"HISSIONIHG

a. Records of information fapor tan t ta t h e s a f e and e f f e c t i v e decowissioning of t he f a c f l l t y maintained ir: an independent and iden t f f i ab l e loca t ion un:: 1 1 icense termination f30.3S(g)]

b. Records incigde a l l in fomat ion outl ined i n ( Y O N

t30.35(0)1

J ( J y o n

Remarks.

21. INDEPENDEHT MEASYREHEKTS 75cp5y d-/& &a a. Survey f n s c m n t used

b. NRC Ser ia l tlc. &/ -'%FA/

c. Last date cf cal ibrat ion

d. Inspector ' s 8easurcl~nZ.s ~ r r d l fc rnsee ' s

e. Describe t-3e type md r i i su l t t of m u m n u = &.&&A 4 &&- /-,.,G k+y u v/ . ,&&&& &s/ ,& ?LLI* Li.4

- 4

s-/- L r u L ~ ."w--'""7 4 J// Lh$yL

,, - .- I . ?CPCI ,~ yL- L>,< -c< 1 4

,kr:i.q.c . O , $ > * L / k C - Yz? ~ k - "/' "GZ pThe i c l . i~l~k 5 b9? o r P C , fiqIL8-

1-(25

25. P E R F O W N C E EVA,UAV"H FACTORS

Licensee Inspec to r (name &

. l o c a t i o n ) Inspect lon Date

a. back of s e n i o r aanageannt involvement wi th t h e r a d i a t i o n s a f e t y program and/or Radiat ion S a f e t y O f f i c e r (RSO) o v e r s i g h t ( ) y ( d i ;

b. RSO t o o busy with o t h e r a s s ignnen t s ( 1 y ( 4 ' i

c. I n s u f f i c i e n t s t a f f i n g

d. Radiat ion S a f e t y C o s l m i t k c f a i l s to ~ e t o r func t ions i n a d e q u a t e l y

e . Inadequate c o n s u l t i n g s c r v i c a s o r inadequate aua: t s ( > y ( d ~

Remarks (cons ider cove a s s e s s a e n t and/or o t h e r p e r t i n r n t PEFs):

Regional f o l l a r u p on above PEFs c i t a t i o n s :

/' . -

~ ~ , b . i - ' ~ V I ~ C c: by kTG,-m2i i,,,r-;.?Fr . .- ir idii C 1 y 5 / . ij

3c. Individuals contacted:

*Col. Francis O'Donnell - Deputy for Preventive Medical Services *LTC Arthur Sarniljan - Radiation Protection Officer (RSO on license) CPT Henry Synder, Branch Chief, Tech Services Branch David Burton - Branch Chief, Radiation Materials Control Branch SFC Mark Rook - Health Physicist Col. Jay Anderson - Chief, Nuclear Medicine Clinic SSG Michael Williamson - Radiation Safety Technician Simon Bautisa - Senior N.M. tech Angel Chevas - N.M. tech CPT Raymond Murry - Radiopharmicist Debra Holton - nurse Nancy Saxson - nurse Dr. Vahey - Authorized User Dr. Bunt - Authorized User Dr. Hansen - Authorized User Irene Gist - Authorized User Dr. Billy Bass - Authorized User CPT Milanson - Branch Chief, Operations Branch SFC Green - Radiation Safety Technician SSG Lea Gaha - Radiation Safety Technician

3d. Nuclear Medicine: - 6 rooms - 9 cameras - starting time 6 a.m. - bulk liquid 1-131 stored in hood and vented before administration - mini hood inside larger hood for working with 1-131 - Xe-133 unit doses uses - normally use a Pulrnonex vent system but at the time of the

inspection it was being repaired. A RadX system was being used in its place. - approximately 2 Xe-133 patientslweek - a computerized management system is being used. The licensee wants to enlarge it

so that all N.M. records can be stored on the computer system

RIA: - normally less than 200 uCi on hand at one time - 2 full-time staff members - daily surveys with a pancake probe - waste picked up every 2-3 weeks by HP staff

1%. Radioactive waste is stored in building 16. The licensee feels that there is plenty of room for storage if future problems of burial site access arise. The waste is compacted at building 16. A dedicated vehicle for transporting waste is used to pick up waste at each site and deliver to building 16. Waste is picked up weekly by the HP staff.

APPENDIX B

NUCLEAR MEDICINE INSPECTION FIELD NOTES' Region I

Inspection Report No.. .. .58.~(?.?.!. ............... ~i~~ NO. .......................... D F - w ~ ~ K - D I , 03 Licensee (Name and Address): ~ k e t No. .*.???/,3,!?. Q . % . ~ @ ~ T /r . ........ .... .. ........... ..................................................... .... ....................

..... ..................... Last Amendment No.

Program Code: (d 021 10 - Broad Scope ( ) 02120 - Limited

\ ( ) 02121 - Custom ( ) 02200 - Private Practice - LimiM ( ) 02209 - In Viv~ ( ) 02201 - hivate Practie - Custom ( ) 02210 - Eye Applicator ( ) 02220 - Nuclear Medical Van ( ) 02230 - HDR ( ) 02410 - In Vitro ( ) 02400 - Veterinary . ( ) Other -

Type of Inspection: 1

( ) Announced ( Unannounced ( ) Routine

d ( Special

( ) Initiai , ( ) Reinspection

summary of Pidiigs an@: ( No violations, Clear 591 or letter igsued

.... ( ) Violations, 591 or letter ibued . .. ( ) Action on Previous Violations

.. .... . ...

. . . .:..... . .

'All areas indicated in field notes are not required @-be addressed during cakh in'spxtion. . . -

Appendix B, 87100

I - i .

1. - ORGANIZATION -

a. Organizational structure meets license requiremenu WC) 6/) Y ( 1-N

................................................................................. Remarks:

............................................. ................................ . i " . r?r tmc. . . . . . . OF i P 7 - . , . : .: .. 5 . ".

b. Use by authorized individuals [35.22@)(2)]

............................................................................ Remarks:

c. Radiation Safety Committee ( NIA

(1) Me~nbcrship as specified in [35.22(a)(l)j (2) Meetings held quarterly [35.22(a)(2)]

( 4 ~ ( ) N ( y O N

(3) Quorums established per [35.22(a)(3)] ( ? )Y ( ) N (4) Has sufficient authority per (35.231 ( Y O N (5) Cornmittcc reviews conducted per [35.22@)] (6) Record of Committee meetings [35.22(a)(4)]

I 2: peeti 'nz 5:

Remarks: ..... ............................ -. ............................

............................................................ ............... ............................................................. ..............

.............................................................. ................

d. Radiation Safety Officer

( 1 ) Appointed [35.2l(a)] (2) Fulfills duties per [35.21@)] (3) Has sufficient authority per f35.231

.................................................................... Remarks: ... .'. ...

Appendix B. 87100 B-2 Issue Date 021 1919 1

e. Visiting authorized user

(1): Has wri tten'permission [35.27(;)(1)] " O Y O N (2) Copy of vi$torls licenseon,file [32.27(a)(2)] ' ( ) Y ( I N (3) Performs'only those.procedures authorized on ....

. visitor?^ license [35.27(a)(3)] " ' ( - ) Y O N (4) Uses material under licensee's li&nse for

. ,. . . . . . sixty days pet y&.or less [{35.27@)] * * . . . ( ) Y (9N (5) Records m&n&nhed 3 years after l& visit 05.27(c)] O Y O N

Remarks: ...............................................................................

f. Mobile Nuclear Medicine Service

(1) Licensee uses mobile nuclear medicine services 135.291 ( ) Y ( ) N (2) Licensee operates mobile nuclear medicine services

D5.29,35.80] ( ) Y O N Remarks: ...............................................................................

2. Inspection History ( ) NIA - Initial Inspection

a. Last inspection conducted on

b. Violations or deviations were identified

,

c u i r e m e n t , Violation Corrective Action Taken (YIM Status l a L F ~ .a0 r ?. ?!. H.J.OX . .............................

............................

Appendix B, 87100 h u e Date: OU19f92 1 . . 1

e. Any previous violations not corrected

a. Licensee has multiple authorized locations of use ( ) Y ( )N b. If so, list location(s) inspected

f l L C 4 . t . M ( N/A

wt?emt... -eemgiw be D L . . . . . . . . . . . . . . . . . . ......................................................................

c. List those individuals contacted during inspection:

I.C'Q+IGOS H~,. Mi 6 /+'%& D'&&/ / ? r .................................... ......................... SaUL- bkCo!. .R.& ..%mt . 1 ? : + 2 j . R ~ ~ . . . ............. .gFk.~pl'aa~.~e..~i.b7dq.+k~i~k~., a d p u

/ ....................... ............. ............ .... ~u&G. .Say&r7 .Hi?? i .szC. !& TL.RM P .......................................................... . 2 k . . .L!*. .&fl.h. / . .S&b..

...... .GT+IC;.. . r~prgtts.Gn. , . .i?lA .......................................................

..........................................................................................

..........................................................................................

.......................................................................................... 'Indicates presence at exit meeting

d. Briefly describe scope, including types of use involving byproduct material, frequency of use, staff size etc.

. . . ............................................... ? ..........*....................... ......... .\

e. Radiation safety changes pursuant to 135.311 ( ) Y ) N $,: f. Records of changes maintained (35.3 I@)] ( ) Y O N

Remarks: ................................................................... - ...........

Appendix B, 87 100 B-4 Issue Date: 02/19/92

4. INTERNAL AUDITS OR INSPECTIONS

a. Audits o r inspections a re conducted

. (1) Audits co"ducted by .. .GI?eJ .be l . . . ................... '' .

. . h Frequency _. &!?Y!UIC~! ............................... . .L _ . . 7 . ,

I ' ' b. Audits 'are -required by license condition . . c. . Records maintained

, . . . Remarks. .................................... I-. ................. :. .... : ................... -. ...

..........................................................................................

5. TRAINING. RETRAINING. AND INSTRUCTIONS TO WORKERS

a. Instructions to workers per 110 CFR 19.121

Remarks ................................................................................ ..........................................................................................

b. Training program required [UC] ( Y O N O N I A J (1) Training prograrli implemented (2) Retraining program required (3) Retraining program implemented (4) Records maintained

Remarks ................................................................................

C. Supervision o f individuals by authorized user in accordance with [35.25] ( L i l N

Appendix B. 87100

i

6. FACILITIES AND EOUIPMENT

a. Facilities as described in license application ) Y ( ) N

(I) Adequate ~ncthod used to prevent an unauthorized individual fro111 entering restricted area

(1) Licensee possesses and uses dose calibrator(s) per [35.50(a)]

(2) Constancy checked per [35.50(b)(I)] (3) Linearity tested per [35.50(b)(2)] (4) Accuracy tested per [35.50@)(3)] (5) Geonletry dependence tested per [35.5O(b)(l)] (6) Readings mathe~natically corrected if linearity error is

greater than 10% per [RS.SO(d)] ('7) Records ~naintained [3S.S0(e)J (8) RSO signs linearity, accuracy and geometry

dependence tests [BS.SO(e)]

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Appendix 8. 87100

d. Survey insir;llnents

( 1 ) Appropriate operable survey instruments possessed per . [35.120, 220, 320, 4201 or available b r [35.520]

(2) Calibration performed as required by [35.51] (3) Records n;aintained [35.5 1(d)] (4) Proper operation checked with check source

per (35.5 1 (c)]

( Y O N ( Y O N ( tf " O N

Y ( I N

Remarks ................................................................................

e. Syringes containing RAM properly labeled and shielded unless contraindicated per [35.60]

f. Vials containing RAM properly labeled and sllielded per (35.6 I]

7. RADIOLOGICAL PROTECTION PROCEDURES

a. Radioactive ~naterial used i n accordance with current procedures [UC]

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b. Individuals' understanding of current procedures is adequate I

( I ) in general rules for safe use of RAM (2) in emergency procedures

Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Appendix B. 87100 Issue Dare: 021919 1

8. MATERIALS

a. Licensee uses unit doses

b. Licensee uses generators ( J Y O N

c. Licensee possesses sealed sources or brachytheiapy sources per [35.59]

d. Isotope, chemical form, quantity and use as authorized [UC, 31.11, 35.100, 200, 300, 490; 5001

, . . - -_---

................................................................................ Remarks

..........................................................................................

..........................................................................................

.......................................................................................... .......................................................................

e. Molvbdenum-99 breakthrough ( ) NfA

( I ) Test performed per [35.204@)] (2) Records maintained per [35.204(c)]

................................................................................ Remarks

f. Leak tests and Inventory

(1) Leak tests pcrforn~ed on sealed sources and brachytherapy sources per [35.59@)]

(2) Inventory of sealed sources and brachytherapy -sources per [35.59(g)]

(3) Leak tests records in microcuries (4) Leak testlinventory records signed by RSO (5) Records of leak tests and inventories

maintained for 5 years

......................... Remark ..................................................... :

..........................................................................................

. .

Appendix 8. 87100 B-8 lksue Dare: 0~19191

9. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL

a, Describe IIOW packages are received and bx whom: .-

( 1 N/A

.... .; .............................

.... ........................

b. Opening procedures established and followed per [20.205(d)]

c. Incoming packages wiped per [20.205@)] d. Incoming packages surveyed per [20.20S(c)] e. Transfer(s) performed per [30.41] f. Records of surveys and receip~/transfer

maintained per [20.401@) and 30.511

Remarks' .. .a. e..

10. AREA SURVEYS ( ) N/A

a. Ambient exposurc rate surveys conducted per [35.70(a),(W2(c)l

b. Contamination survcys conducted Per [35.70(e),(f)l

. .

t i / ly ( I N c. Trigger levels established [35,7O(d).&]. . , . ,

d. Exposure rate survcy records in rnRIhr, . . . ' . , , e. Contamination survey records in dp&lOO cml f. Records maintained per 135.70(h)]

Remarks ................................................................................ i

11. RADIOPI-IARMACEU'TICAL THERAPY ( NIA

a. Licensee provides safety instruction per [35.310] and j

Jjy ( ) .N - . implements safcty precautions [35.315] or equivalent [UC] . -

' ' (JY O N ; b. Patient room contamination surveys per [35.315] - .:

C. Release of patients containing . J I;ldiopharmaccu~icais meets [35.75] ( > y ( 1.N 1 . . I

Lp~-

Appendix B. 87100 13-9 1 I w c Dare: OU19B1 I

d. Thyroid burden nreasured on individuals involved in dose adnrinistrations [35.315(a)(8)]

e. Records maintained

a. Licensee provides safety instruction [35.410] and implements safety precautions 135.4 15) or equivalent [UC]

b. Patient surveys perfor~ried per [35.406] '

c. Release of patients containing permanent implants lrieets [35.75] (LAY ( ) N

d. Release of patients treated with telnporary implants meets [35.404] ( y O N

e. Brachytherapy soilrces inventoried per (35.4061 ( Y O N f. Brachytherapy source storage area surveyed

quarterly and record signed by RSO [35.59(h)]

$ g. Records maintained

c. Reports reviewed by 4 5 ~ . ....................... ~req~lellcy ? * Q c ~ Q ~ : ! ~ . .....

d. NRC inspector reviewed personnel c~ronitoring records for

: period . Jkv. .~!l!t+. . . . . . . . . . . to .. .mo, 19TJ . . . . . . . . . . . . . . . . . . . . . . "1 ! '- . e. NRC forms or equivalent

( I NRC - 4 ( ) Y ( ) N Complete ( ) Y ( I N (2) NRC - 5 ( ) Y O N Complete ( )Y ( ) N

f. List maximu111 exposures (cl~illirenls):

&- F)km 3 t'rnik L- OLRQfi 3- ~ r ~ l l i k ~ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (1) Whole Body ( 2 ) Extrelllity

. .

I

g. Licensee has implemented an ALARA program [35.20] ' ( l Y ( ) N

Remarks . . . . . . . . . . . . . . . . . . . . . . ,; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

a. Potential for exposure of individuals to airborne RAM exists ( d' )Y ( I N b. Monitoring for airborne radioactivity conducted per 20.201(b)

to meel [20.103. 35.90 and 35.2051 ( Y O N c. Records maintained [20.401. 35.205, and UC] ( Y O N d. Bior)ssay program in~plenlented as described in

correspondence.with NRC . *

1 . .

, y Remarks ... .: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :. . . . : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

e. Radioactive gases

(1) Clearance time and safety procedures are posted [35.20S(d)]

(2) ~eu&ble collection systems checked c~lo~~thly (3) Ventilation rates cliecked each six nionihs

for negative pressure [[35.205(e)]

15. RADIOACTIVE EFFLUENT AND WASTE DISPOSAL

a. RAM in eftlt~ents to unrestricted areas ( ) y ( ) N

b. Release in accorda~lce with resulatory lin\its [20.105[a)] ( d ~ ( ) N

....

'c. Describe waste disposal method(r)- solid and liquid:

Remark . .

. . . . . . . . ..

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alqwidix 6. S7100 ls%ur Data: 021 1919 1

I

d. If LLW is stored because access to a burial site has been denied, answer (I), (2) and (3) below:

1 (1) Adequate control of waste storage is niainlajned ('1) Y ( ) N (2) Package is labeled and package integrity

is adequately maintained (3) Adequate records of surveys and material

( / ) Y ()N

accountability are maintained (dy ( )N e. Disposal of waste in accordance with regulatory

requirements [20.301 and 35.921 f. Decay-in-storage waste disposed per [35.92] g. Records maintained [20.401@) and 35.92@)]

16. NOTIFICATIONS AND REPORTS /

a. Licensee in compliance with [19.13] (dy ( ) N o N / A (reports to individuals)

b. Licensee in compliance with [20.204] (theft or loss)

(3/u ( N ( )NIA

c. Licensee in compliance with [20.403] (incidents)

d. Licensee in compliance with [20.405] (overexposures)

Remarks .................................................................................

..........................................................................................

..................................................................................... :....

a. Misadministrations have occurred

(1) Diagnostic (2) Therapeutic

b. Licensee in compliance with reporting therapeutic misadministrations [35.33(a),@)]

Appendix 8. 87800 8-12

?

c. Licensee in compliance with reporting diagnosiic misadministrations, if required [35.33(c)]

d. Appropriate action taken to prevent recurrence e. Records maintained [35.33(d)]

18. POSTING AND LABELING

a. Form NRC-3 "Notice to Workers" posted b. Other posting and labeling per [20.203] . Remarks ...............................................................................

19. TRANSPORTATION (10 CFR 71.5fe) and 49 CFR 171.189) /

a. Licensee makes shipments of RAM

. . . . .......

c. Licensee is aware of LO CFR 61 requirements d. Licensee classifies and characterizes waste e. Shipments

(1) Authorized packages used [173.415.416] (2) Package type used . . (3) For DOT-7A packages, performance test record

on file [173.415(a)] (4) For special for111 sources, perfortnance test

(,,A ( ) N ONlA

record on file [173.476(a)] (5) Packages properly labeled [172.403, 173.4411

( Y ( N VINIA a y ( 1 N ( )NIA

(6) Packages properly marked [172.300] (7) Proper shipping papers prepared

$4'~ ( N ( )NIA

and used [172.200-2041 ( ) N ( )NlA

Remarks ............................................................. ; ................

f. Licensee inakes return shipments of radiopharmacy doses ( ) Y J ) N ( )NIA

(1) If YES, licensee assumes responsibility of all shipper requirements ( I Y ( )N

(2) If NO, describe arrangements made between liensee and radiopharmacy as to performance of shipper responsibilities:

* . . 6' ,..- 4 . . ,~ ......................................................................................... . . . . ' . .:*. . :. . . - . ~ . . - .......................................................................................... . . . . . ,.' . ', , , . . . . ' - . = ..........................................................................................

I\ ,' . . O ; . ~ . ~ ?, .., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20. RECORDKEEPING FOR DECOMMISSIONING

a. Records of information important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination [30.35(g)]

b. Records include all infor~nation outlined in [30.35(g)]

Remarks ................................................................................ u .........................................................................................

21. INDEPENDENT MEASUREMENTS

a. Survey instrument used ................ ;. ............. d-5

b. NRC Serial No. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C. Inspector's measurements were colnpared to licensee's ( ) Y O N

d. Describe the type and results of measurements:

..........................................................................................

..........................................................................................

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22. BULLETINS AND INFORMATION NOTICES

' a. Bulletins. Information Notices. etc., received by the liensee Y ( ) N b. ~icensek took appropriate actions in response to

Bulletins: INS, etc.

Remarks ................................................................................

Appendix B. 87100 B-14 Issue Date: OUl9/9 1

i 3 . CONTINUATION OF REPORT ITGMS

Appendix 8, 87100 Issue Date: OU 1919 1

24. LlST OF VIOLATIONS i

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

..........................................................................................

..........................................................................................

..........................................................................................

..........................................................................................

..........................................................................................

..........................................................................................

..........................................................................................

..........................................................................................

..........................................................................................

...................................................................<...................... Appendix B, 87103 B-16 Issue Date: 02/19/91

25. PERFORMANCE EVALUATION FACTORS

. . . . . ............................. ~icensee ~nspector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inspection Date. ... 2.u -2.3 .?5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7/ / a. Lack of senio; management involvement with the radiation

safety program and/or Radiation Safety Officer (RSO) oversight ( ) Y ( d N b. RSO too busy with other assignments ( ) y ( d ~ c. Insufficient staffing . ( )Y (d~ d. Radiation Safety Conunittee fails to meet or functions inadequately ( ) Y (&N

e. Inadquate consulting services or inadequate audits

Remarks (consider above assessment andlor other pertinent PEFs): " .

Regional follow-up on above PEFs citations:

Appendix B. 87100 Issue Date: 02/1919 1

ADDENDUM

. +- , * INTERIM FIELD NOTES

QUALITY MANAGEMENT (OM) PROGRAM

1. ' GENERAL

a. License number(s): ..1!.6: / D / 3 .................................... 3 8-6-

" b. Docket number(s): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 036 - t> /3 /3 w

c, Last inspstion datc(s): . . d /.? .........................

0 b z,,,,-F3 .......................... d. Current inspection date(s): ..... D. :! 5 .?:

2. MODALITIES

a. Procedures the licensee performs:

(1) Teletherapy Y N (2) Gamma Stereotactic Radiosurgery Y N (3) High-Dose-Rate Remote Afterloading Brachytherapy N (4) All Other Brachytherapy (5) NaI 1-125 or 1-13 1 > 30 microci

Q N

(6) Therapeutic Radiopharmaceutical Other than (5)

3. PROGRAM

a. Licensee has a written Q M program, as applicable, that covers all policieslprocedures that require a written directive and program review [35.32(a) and @)(I)]

b. Written QM program and certification (for existing , licensees) submitted to NRC [35.32(f)(2)] Date:. .. ..... :.. :

Remarks ................................................................................

SUPERVISION

a. Supervised individual(s) inslructed in the QM proglam applicable to the modality of use [35.25(a)(l)] @ N ( S W )

(1) If any individual(s) has not received training, docun~ent their names and position. Additionally, briefly describe the reasons as stated by the individual, the RSO, and the supervising authorized user:

.......................................................................................... Date: .......................

Remarks ................................................................................

APPENDIX B I

NOTE: All areas indicated in field notes are not required to be addressed during each inspection

NUCLEAR MEDICINE INSPECTION FIELD NOTES

I Region I

Inspection Report No. 0 3 Q - 0 (3 /7/4f/-80/ License No. D 8- o/ 73 g -02

Licensee (Name & Address): Docket No. @30 - 0 /3/ 7 D ~ ~ q + - f m e r Z o f t-/;e A+-Y W k / + e ~ eee8 fteAt'eo/ 'ch.,.ri~e.. W I L S ~ / ~ ~ & ~ DC 2 0 , 3 0 7 - S ~ ~ f

J

Licensee Contact &/. d;/liz, 8. Tohysoy Telephone NO,(~O ( ) 42 7 -5 (d / Last Amendment No. '6'4- Date of Amendment S&//W, Priority: / Program Code 2 ((0

Date of Last Inspection 7/20 - 2 3/73 Date of This Inspection 9/20 -23'/Sy

Type of Inspection: ( ) Announced ( finannounced ( M o u t i n e ( ) Special ( ) Initial ( ) Reinspection 6 '.

Next Inspection Date 3/76 ( ) Normal ( ) Reduced (fixtended

Summary of Findings and Action:

( 40 violations, Clear *issued ( ) Violation(s), 591 issued ( ) Violation(s), Regional letter issued ( ) Followup on Previous Violations

Were non-cited viol ations identified during this inspection? Y C M Was proprietary information reviewed by w-m&w&& the inspector?

Inspector: 9Yd3TZL--- (Signature)

Date ?/-?g/?~ I

Approved: Date

Issue Date: XX;XX/XX (RI rec'd 03/10/94)

87100, Appendix B

(Signature)

1. INSPECTION HISTORY ( ) N/A - Initial inspection A. Violations were identified during the last *

inspectiont B. Response let-

( ) y (4" C. Open viol ations from previous inspections:

Status Reouirement !!j&j&& Corrective Action Taken (YINI OoenlCl osed

D. Explain any previous violations not corrected or repeated ( ) N/A

2. 0-

A n"

gpdEcr~:~t. c ~ I . k/m. X i h m o n cap+. & 4 r y snydet- 5y.g. C r o r c ~ A e r 5 f. d/&er 4 + G - t q y 5 Individuals contacted during inspection

Individuals present at exit meeting

1. Meets license requirements [L/C] ( W O N 2. Multiple authorized locations of use (4-y ( 1 N

If so, list location(s) inspected ( 1 N/A Hain C4-+7d3, lda5&;.yb q D. C, F o ~ a 2 . l 6-1,. F~L;/~+;Ps, i/;/"** 5 ,,L >. ~4 & Rocku:l/e, MD ~ + ~ ; / ; b i ~ > f /

3 . Briefly describe scope of activities, including types and quantities of use involving byproduct material, frequency of use, staff size, etc. ~./&wj, aflOad s.?' peg..,., -, .&4

46sc++ w /.SO * ~ e q f i - k J - T ~ s . ~ ; c e ~ a e e d o e s fiai,,/ C-25 p r o s e h r ~ s /4at), & 6 ~ ~ s / ; ~ f h e r e p ; ~ C* /s;/ll=-J s,r 9. AN ex+. bedm ,> UNAC. A/o @R

8 TA q j- Nq;A Cqr*lpr> 4 H J ' & Ff. ~ e a d e . B. Research involving human subjects ( 1 N/A

M o ~ e C ~ ~ Y Y Q Y J + / ~ ( I L C : ~ C 87100, Appendix B Issue Date: XX/XX/XX

(RI rec'd 03/10/94)

1. Licensee's comnittee (IRB, RDRC, o r other) as const i tuted, was approved by the FDA [L/C] (&( ) N

2. Licensee has procedures t o requi re the intended study be reviewed by the committee [L /C j i o i j n

3. Licensee has implemented procedures t h a t requi re human subjects t o provide informed consent p r i o r t o p a r t i c i p a t i o n i n RAM studies [L/C]

4. Licensee has par t i c ipa ted i n research studies s ince the l a s t inspect ion O Y ( 9 ' N

a. Number o f studies b, Number o f par t i c ipan ts

Remarks :

Radiat ion Safety Comnittee ( N/A

1. Membership as spec i f ied [35.22(a)(l)] 2. Meetingsheldquarterly[35.22(a)(2)] 3. Record maintained [35.22(a) (4)]

Radiat ion Safety O f f i ce r

1. Appointed [35.21(a), 9001 2. F u l f i l l s du t ies per [35.21(b)]

( * O N

3. Has s u f f i c i e n t author i ty per [35.23] O N ( ( 1 N

Radiat ion Safety Program

1. Minor changes pursuant t o l35.311 ( Y ( ~ ( ~ A ( / A 2. Records o f changes maintained [35.31 (b) ] 3. Content and implementation reviewed annually

O Y O N

by t he l icensee [20.1101(c), 35.22(b)(6)] 4. Record o f reviews maintained [20.2102]

( L Y ~ O N (.*T ( N adi,A irMdiXr rp, , iew~Prug#ed ;- q / / / / ( b n i o L PO p e v - e d

Use by authorized ind iv idua ls [L/C] V i s i t i n g Authorized User

ON ( L Y N I A

1. Has w r i t t e n permission [35.27(a)(l)] ( ) Y O N 2. Copy o f v i s i t o r ' s l icense on f i l e [35.27(a)(2)] ( ) Y ( ) N 3. Performs only those procedures authorized on

v i s i t o r ' s 1 icense [35.27(a)(3)] 4. Uses mater ia l under licensee's l icense f o r

O Y O N

s i x t y days per year o r less [35.27(b)] 5. Records maintained [35.27(c)]

( ) Y O N O Y O N

Mobi le Nuclear Medicine Service (<MIA

1. Licensee operates services per [35.29, 801 2. Compliance w i t h 20.1301 evaluated and met

O Y O H ( ) Y O N

Any Amendments o r Not i f i ca t ions since 1 ast inspect ion [35.13, 141 ( & ( ) N

Issue Date: XX/XX/XX ( R I rec'd 03/10/94)

87100, Appendix 5

A. Ins t ruc t ions t o workers [19.12] B. Ind iv idual ' s understanding o f current procedures and

(4'~ ( 1 N

regulat ions i s adequate C. Tra in ing program requi red [LIC]

( " / V O N ( 4 - y ( N

1. I f so, b r i e f l y describe t r a i n i n g program: A d f ~ b ~ ; ~ ~ LCJeflJ ffl4rk [&d &o*&r?f15 &Or)% /?ad

p ~ o f e c f,;, o/&. ,.4, &,;, 1: 6 6.4. P++aA ~ F g k e &a ~ * - d , ' d e s f#ql;f,;y f&r ,kd,vIde(s 4 e d y r - ~ / " " ~

.

2. Tra in ing program impl emented 3. Per iodic t r a i n i n g program requi red 4. Per iodic t r a i n i n g program impl emented 5. Records maintained

D. Supervision o f ind iv idua ls by authorized user i n accordance w i th [35.25]

E. Therapy t r a i n i n g ( 4 ' Y O N ( 1 N/A

1. Safety i n s t r u c t i o n 135.310, 410, L/C]

a. Control o f pa t i en t and v i s i t o r s b. Contamination and waste c. Sizelappearance o f sources d. Hand1 ing lsh ie ld ing o f sources

o y (W

e. RSO n o t i f i c a t i o n i n emergency o r death f. Records maintained [35.310[b), 4101b) J

2. Manufacturer's ins t ruc t ions ava i l able and followed [35.59(a), 4001 ( ) Y ( ) N fJ/f

3 . Tra in ing f o r operating and emergency procedures f o r HDR Remote After loaders [LIC] ( 1 y ( 1 N ( W I A

F. Revised Par t 20 Rsl;dc;ovc Pro tec+:oq o PL'er

WarkePr cognizant o f requirements for:

1. Radiation Safetv Proaram 120.11011 I ~ ~ Y ( ) N -. - - 2. Annual dose ~ i m j t s [20.1361, 1302j i i i ~ 3. New forms 4 and 5 4. 10% monitoring threshold [20.1502]

(4-y 1 N ( ) NIA ( P I N

5. Dose 1 im i t s t o embryolfetus and declared pregnant worker [20.1208]

6. Grave Danger Posting [20.1902] ( ) Y O N ( 7. Procedures fo r opening packages [20.1906] (&Y ( ) N ( ) N/A 8. Sewer disposal 1 i m i t s [20.2003] (fi( 1 N ( 1 N/A

NOTE : - Deficiencies i n Section 3.F, wh i le not always a v io la t ion , should be brought t o the a t t en t i on o f l icensee management a t t he e x i t meeting and i n t h e cover l e t t e r t ransmi t t ing the inspection repo r t o r NOV.

87100, Appendix B Issue Date: XX/XX/XX ( R I rec 'd 03/10/94)

Remarks :

4. FACILITIES

A. Facilities as described in 1 icense application B. Storage areas

(d( ) N

1. Materi a1 s secured from unauthorized removal or access [20.1801]

2. Licensee controls and maintains constant (,z/v ( ) N

- - .

surveillance of 1 icensed material not in storage 120.18021 (f l( 1 N

3. Licensee-uses process or other engineering controls, for volatiles/gases in storage 135.901

4. Maintenance program implemented for engineering (b'fY ( 1 N

controls (negative pressure, ventilation rates, filter changes, etc.) [35.205(e), L/C] 0 ~ 0 ~ 4 %

Re sen*-4 f 2 *pfi-d aCe0S3 c-,~,, LIwpa5 5. E()"IPMENT d"d 5'?r,p: Gdy. It 2 yo;np 3-6 be ~ ~ r t s o ~ d e + e d /

;4rd *' " b'c/JJ .9 ,if &,b-.IC'%/c,

A. liosa cai i brator ( ) N/A

1. Possessed and used [35.50(a)] 2. Constancy [35.50(b) (l)]

a. Performed daily b. Dedicated check source used

(?fry ( 1 N ( 9 ' Y N

3. Accuracy [35.50(b) (2)]

a. Perforated at installation and annually ( T Y ( ) N b. At least 2 sealed sources used (Wry ( 1 N

4. Linearity [35.50(b)(3)]

a. Performed quarterly b. Includes range between 10 uCi and the

(4~0~ highest dosage administered ( L A N

5. Geometry Dependence [35.50(b) (4)]

a. Performedatinstallationorrelocation (4~ ( ) N b. Includes range of volumes and volume

configurations used ( ~ Y N

6. Dosage readings mathematically corrected for geometry or linearity errors greater than *lo% d/fl

Issue Date: XXlXXjXX (RI rec'd 03/10/94)

87100, Appendix 8

[35.50(d)] 7. Repaired o r replaced when constancy o r

O Y O N O N / A

accuracy e r ro rs exceeded f10% [35.50(d)] ( ) Y ( ) N ( ) N/A f l f i 8. Approved procedures fo l lowed [35.21, 25, LfC] ( ; Y Y ( ) N 9. Records maintained and signed by RSO [35.50(e)] (L)LY ( ) N

0. Licensee uses generators (WON

1. Each eluate/extract used f o r radiopharmaceuticals tes ted f o r Mo-99 breakthrough

2. No radiopharmaceutical s administered w i th Mo-99 ( K Y O N

concentrations over 0.15 uCi per mCi o f Tc-99m ( <Y ( 1 N 3. Records maintained [35.204(c) J ( ( 1 N

C. Syringes proper ly labeled and shielded [35.60] D. Via ls kept i n a sh ie ld [35.61(a)] E. V ia l sh ie lds labeled [35.61(b)] (wf ( 1 N

A. Isotope, chemical form, quant i t y and use as authorized [31.11, 35.100,200,300,400,500, L/C]

0. Licensee uses u n i t doses (WON

z * ~ f , i33/fCI -, ( lyv 1 N C. Use o f radiopharmaceutical s [LfC] ""'Y r

1. Protect ive c lo th ing worn 2. Personnel r o u t i n e l y monitor t h e i r hands

( $ / Y O N

3. No eat ingfdr ink ing i n use/storage areas (WON

4. No food, drink, o r personal e f f ec t s kept (t-w ( 1 N

i n use/storage areas 5. Proper dosimetry worn

( W O N

6. Radwaste disposed i n proper receptacles ( 4 - y ( N (4 'Y ( N

D. Leak t e s t s and Inventor ies M / C 1. Leak t e s t performed on sealed sources and

brachytherapy sources [35.59(b)] ( ) Y O N 2. Leak t e s t records i n microcuries 3. Inventory o f sealed sources and brachytherapy

O Y O N

sources performed quarter1 y [35.59(9) 1 4. Inventory performed promptly a t the storage area

O Y O N

a f t e r removing sources from a pa t i en t and includes requi red in format ion [35.406(a)] ( ) Y O N

5. Records maintained & signed by RSO [35.59, 4061 ( ) Y ( ) N

Remarks :

87100, Appendix B Issue Date: XX/XX/XX ( R I recyd 03/10/94)

7. RADIATION SURVEYS

A. Survey instruments used t o show compliance w i t h Par t 35 I Appropriate operable survey instruments possessed [35.120, 220, 320, 4201 o r avai 1 able 135.5201 Cal ibrations,[35.51(a,b)]

( & O N O N I A

b ~4 ;C-z~+er ,'n /Q~~L ,$ , HD (de,fL Ply5;~ r - ( t - v / r~s ? a. B e f o r l f i r s t use, annually & a f t e r repa i rs ( SfY ( ) N b. Approved c a l i b r a t i o n procedure fo l lowed t o

include check source reading determination [35.51(a) (3), LICI

c. Within 20% i n each scale o r decade of ( Y r Y ( 1 N

in te res t [L/C] ( < Y O N

3. Records maintained [35.51(d)] 4. Source-checked each day o f use [35.51(c)]

0. Radiation surveys performed

1. Da i l y i n a l l prepared o r

2. Weekly i n a l l areas where o r waste i s stored fl ( ) #

3. Weekly wipes i n a l l I are routine1 y prepared, administered o r stored /35.70(e)] B 4 . . f (4~ ( N

4. Quarter ly i n brachy 6 e r apy source storage area ( 9 Y ( 9

C. T r igger leve ls [35.70] I

D. Techniques can detect 0.1 mR/hr, 2000dpm C35.70 E. Records maintained [35.70(h), LJC] F. Protect ion o f members o f the pub l i c

1. Established 2. Exceeded

(&( ( ) Y ($NCMok

3. Corrective ac t ion taken and documented ( Y O N Q / A

Note: See IN 94-09 f o r updated guidance on conflicCs between Parts 20 and 35.

n o h

1. Licensee made adequate surveys t o demonstrate e i t he r (1) t h a t the TEDE t o the ind iv idual l i k e l y t o receive the highest dose does no t exceed 100 mrem i n a year, . . . c&& e M in any fimf and 50 mrem i n a year [20.1301(a)(l), 1302(b)] ( 3 / ~ ( ) N

2. Unrestr icted area rad ia t i on leve ls do not exceed 2 mrem i n any one hour [20.13Ol(a)(2)] ( 6 ) ~

Issue Date: XX/XXJXX ( R I rec'd 03/10/94)

8710C, Appendix B

3. Records maintained 120.2103, 21071 ( y ( ~g/' P L "+f;.f r: 6 '.- Remarks: ,+ t S4 ge /.',+ J ,

15r'Y 7 -em / Pqq! ! c v C /

W 4 5 O . ~ ~ R / A , + ? q ~ ~ s e ~ + W ~ S ( h p / q y t e , J u I ' f 4 & o f 4 /37=

S 1 9 2 1 ~ j f A e +/.,we. ~ i e e v r s e e d s e d m4i4y

<h:e/=fsl

8. RADIOPHARMACEUTICAL THERAPY ( ) N/A

Safety precautions imp1 emented t o include pa t ien t f a c i l i t i e s , posting, stay times, pa t i en t safety guidance re lease and contamination cont ro ls [35.315(a), L/C] ( $Y Area dose r a t e surveys and room contamination surveys [35.315(a)(4j, (7)] .L.:ce,see ere, /+ +de4 (YY Release o f pat ients containing radiopharmaceuticals -?o~ddfl meets <5 mR/hr @ l m < 30 mCi 135.751 RSO promptly n o t i f i e d i f pa t ien t d ied o r had

( 1 y

a medical emergency [35.315(b)] (

Remarks :

9. BRACHYTHERAPY i ) N/k

Safety precautions implemented t o include pa t ien t f a c i l i t i e s , posting, stay times, and area rad ia t ion 1 eve1 surveys 135.415, L/C] ( / Y ( ) N Pat ients surveyed immediately a f t e r implant [35.406] (fl ( ) N Release o f pat ients w i t h permanent implants meets 5 mR/hr @ l m 135.751 O Y ( N O N / A ~ Pat ients surveyed immediately a f t e r removing the l a s t temoorary implant source (required f o r a l l manual LDR, MDR, and HDR therapies) [35.404(a)] '& ( N ( ) N/A Records maintained [35.404(b), 406(d), 415(a) (4)] (M ( 1 N

A

A. Disposal

I a. Approved 120.2001, 35.92, L/C] ( 4 ~ 0 ~

87100, Appendix B Issue Date: XX/XX/XX ( R I rec'd 03/10/94)

b. Procedures followed 135.92, L/C] ( T Y O N c. Labels removed or defaced [20.1904, 35.92]( Jd ( ) N

2. Special procedures performed as required [L/C] ( ) Y ( ) N M/p 3. Improper/unauthorized disposals [20.2001] 4. Records maintained [20.2103(a), 2108, L/C]

O Y ( . r N ( & Y O N

B. Effluents

1. Release to sanitary sewer [20.2003] ( h N ( ) N / A

a, Material is readily soluble or readily dispersible [20.2003(a) (I)]

b. Monthly average release concentrations do ( - O N

not exceed App. B, Table 2 values c. No more than 5 Ci of H-3, 1 Ci of C-14

O N and 1 Ci of all other radionuclides combined released in a year [20.2003] (J /Y ( ) N

d. Procedures to ensure representative sampling and analysis implemented [20.1501, L/C] (fi ( ) N

a. Within unrestricted limits [App B,Table 2]( ) Y ( ) N

3. Air effluents aatk4%s controlled [20.1201, 1301, 1501, 2001, L/C] {See also IP 87102, RG 8.37) (fi ( ) N

C. Waste storage

1. Protection from elements and fire [L/CJ 2. Control of waste maintained [20.1801]

( W O N 3. Containers properly labeled and area properly

( W O N posted 120.1902, 19041 ( 3 / v ~

4. Package integrity adequately maintained [L/CJ ( N Y ( ) N

D. Records of surveys and material accountability are maintained 120.2103, 21081 (4'~ ( 1 Id

A. Describe how packages are received and by whom: *( ) N/A Ail ;r L O M ; , ~ ~ p t c k e y p s *i&d B P I ZD. 1706. Ay R-1 f'*ok

pefisoqnel 4 f c e n t * ( r e ~ e ; ~ f f4.e;/1'i7 ~ - 4 ~ #us/. P d r t v m a c , l r f ~ Y I C , ! Mtd. A/*q.

" s A ; f d r. ce4tta1 A p e y ;q ,/, 5.C. i . u r r e / +;-;me5 =t yefir. SQ yhiS ,4 +e 6 e en s I;?

(RI rec'd 03/10/94)

a Y2 * r * r s 87100, Appendix B

Remarks :

Wri t ten package opening procedures establ ished and fol lowed [20.1906(e)] A l l incoming packages w i t h a DOT labe l u, unless

O N

exempted (gases and special form) [20.1906(b)(l)] Incoming packages surveyed [20.1906(b) (2), L/C] Monitor ina i n ICI and (D) oerfonned w i t h i n time , speci f iedW[20. i906(c)] ' . ' ( < Y ( ) N Transfer(s) between licensees performed per [30.41] ( $Y ( ) N A l l sources surveyed before shipment and t ransfer [20.1501(a), 49 C ~ R 173.475(i),.L/C] Records o f surveys and rece ip t j t r ans fe r maintained

( 4 ' Y O N

[20.2103(a), 30.511 Package rece ip t / d i s t r i bu t i on a c t i v i t i e s evaluated f o r

( < Y O N

compliance w i th 20.1301 [20.13?] &,'++/a e r vlo ( W ( N ,

12. TRANSPORTATION (10 CFR 71.51a) and 49 CFR 171-1891 ( N/A

A. Licensee shipments are:

( ) de l ivered t o cotmnon car r ie rs ( 3 &-ansported i n l icensee's own pr iva te vehic le ( +'both ( ) no shipments since l a s t inspection

ti. Licensee returns radiopharmacy doses O Y ( ~ O M / A

1. Licensee assumes shipping respons ib i l i t y 2. I f NO, describe arrangements made between

( 1 Y ( 1 N

1 icensee and radiopharmacy f o r shipping respons ib i l i t i es :

D. Packages ( ) N/A

1. Authorized packages used [173.415, 4161 (JY ( ) N ( ) N/A 2. Performance t e s t records on f i l e ( ) N/A /J/Z

a. DOT-7A packages [173.415(a)] b. Speci a1 f o m sources [173.476(a)]

( ) Y O N 1 *</.1

Y ( ) Y O N

I 3. Two l abe l s (White-I, Yellow-11, Yellow-111) wi th TI, Nuclide, Ac t i v i t y , and Hazard Class 1172.403, 173.4411 ( ) y ( ) N " &

4. Properly marked (Shipping Name, UN Number, Package Type, RQ, "This End Upn ( l iquids), Name and

87100, Appendix B B-10 Issue Date: XX/XX/XX ( R I rec'd 03/10/94)

Address of consignee) [172.301,306,310,312,324] ( ) Y ( ) N EJ/J 5. Closed and sealed during transport [173.475(f)] ( ) Y ( ) NE//z

E. Shipping Papers ( N/A i 1. Prepared and used [172.200(a)] 2. Proper {Shipping Name, Hazard Class, UN Number,

( H O N

Quantity, Package Type, Nuclide, RQ, Radioactive Materi a1 , Physical and Chemical Form, Activity, Category of label, TI, Shipper's Name, Certification and Signature, Emergency Response Phone Number, "Limited Nantity* (if applicable), "Cargo Aircraft Onlyn (if applicable)} r172.200-2041 (KY ( ) N

3. Readily accessible during transport [177.817(e)]( ) Y ( ) ~ # t l / Z

A. Licensee performed exposure evaluation [20.1501] ( ) Y O N B. Licensee implemented ALARA program [35.20, 20.1101(b)]( ) Y ( ) N C. External Dosimetry ( ) N/A

1. Licensee monitors workers [20.1502(a), L/C] 2. External exposures account for contributions

O Y O N

from airborne activity [20.1203] 3. Supplier drfit! O Y O N O N / A

Frequency M ~ ~ + A ~ , / O ~ ~ , - * ~ ~ 4. Supplier is NVfAP-approved [20.1501 (c)] (cf-y ( 1 N 5. Dosimeters exchanged at required frequency [L/C](&T ( ) N

Internal Dosimetry ( ) N/A

1. Licensee monitors workers [20.1502, L/C] 2. Briefly describe licensee's program for

YON monitoring and controlling internal exposures [20.1701, 1702, L/C]: BtbflSqy & r 10 ' d c r.tes o n 4 t's c . r r *edf / v e &e*q 4 MJCS ,f 34* !Ye , e h e ~ r * = l l ~ ~ ~ ~ f i $ , ' e s

flap p. dl 0b5e/ ~d %@fl5; kr. % 3. Aerosols and gases sampled [35.205] ohcc&4 LW ( ) N

4. Monitoring/controll ing program implebd&d (includes bioassays) [35.315(a), 205(d), L/C] ( f l ( ) N

5. Respiratory protection equipment [20.1703] ( 1 y ( N v / ~

E. Reports

1. Reviewed by "* o g 4 c ~ Frequency * e n t i $ * @uae&r$

Issue Date: XXjXXjXX (RI rec'd 03/10/94)

87100, Appendix 6

2. Inspector reviewed personnel monitor ing records f o r p ' + 2 / Yf 3 * d s , ~ ~

3. P r i o r dose determined f o r i nd i v i dua l s l i k e l y t o 1744 re--& receive doses 120.21041

4. Maximum exposures TEDE Y/q*rw Other YY..+- ( 4 - y ( 1 N

-e%%m,L,Z 5. Maximum CDEs &# /U+,,Organs /rIcyu.,d 6. Maximum CEDE M recl

Y 7. Licensee sums i n te rna l and externa l [20.1202] 8. TEDEs and TODEs w i t h i n l i m i t s [20.1201]

(V / v ( 1 N

9. NRC forms o r equivalent [20.2104(d), 2106(c)] (WON

a. NRC-4 ( 4 ' y ( N Complete: ( ) Y ( ) N b. NRC-5 ( W O N Complete: ( ) Y ( ) N

10. Worker declared her pregnancy i n w r i t i n g dur ing inspect ion per iod (review records) ( ) Y ( ) N ( ) N / A A j / Z I f yes, l icensee i n compliance w i t h [20.1208] ( ) Y ( ) N and records maintained [20.2106(e)] ( ) Y O N

F. Who performed any PSEs a t t h i s f a c i l i t y (number o f people invo lved and doses received) [20.1206, 2104, 2105, 22041 ( ~ N / A

G . Records o f exposures, surveys, monitoring, and evaluat ions maintained [20.2102, 2103, 2106, 35.205(d), 315(a) (8), L/C] (6 N

A. I f misadministrat ions o r recordable events (defined i n 35.2) have occurred since the 1 as t inspection, evaluate the i nc iden t (s) and the l icensee's q u a l i t y management program (QMP) using the e x i s t i n g guidance.

1. Event date Informat ion Source 2. No t i f i ca t i ons

NRC Ops Center ( ) Y ( ) N Region Referr ing Physician ( ) Y ( ) N Patlent

O Y O N O Y O N

I n w r i t i n g ( ) Y O N

I f n o t i f i c a t i o n d i d no t occur, why not:

87100, Appendix B Issue Date: XX/XX/XX (R I rec 'd 03/10/94)

3. Wr i t ten Reports [35.33]

a , Submitted t o Region w i t h i n 15 days b. Copy t o pat ient w i t h i n 15 days

O Y O N O Y O N

0 . Records maintained [35.33(b)] ( ) Y O N

Remarks :

15. NRC INDEPENDENT MEASUREMENTS

A. Survev instrument Ser ia l No. Last ca l i b ra t i on L Y ~ / L ~ , /4-C 14613 6x/o/4 7

B. Inspector's measurements were compared t o licensee's (A ( ) N

+Le C ~ U + #.i+e q -rbar=e S ~ - O / . ~ . = 4+eq , ' 7 @Y(e

,5ueo*,l, (s.L ( / O O O ~ N ."r>A sAfr'r'&'- i;s~~',4W@.,/.. "preee$ w,jL4 I 1 4 ~ r e W C e %reme+&

16. NOTIFICATION AND REPORTS

A. Licansee i n compiiance wi th [19.13, 30.501 (reports t o ind iv idua ls , publ ic and occupational, monitored t o show compliance w i th Part 20)

B. Licensee i n compliance wi th [20.2201, 30.501 ( ( 1 N 1 ) N/A

( t h e f t o r loss) C. Licensee i n compliance w i th [20.2202, 30.501

O Y O N ( M n e

( inc idents) D. Licensee i n compliance wi th [20.2203, 30.501

( 1 Y ( 1 N (Wane

(overexposures and high rad ia t ion l eve l s ) E. Licensee aware o f NRC Ops Center phone number

( 1 Y ( ) N ( H o n e O Y O N f i

17. POSTING AND LABELING

A. NRC-3 "Notice t o Workers" i s posted [19.11] B. Parts 19, 20, 21, Section 206 o f Energy Reorganization

( 4 ~ 0 ~ Act, procedures adopted pursuant t o Par t 21, and l icense documents are posted o r a not ice i n d i c a t i n g where documents can be examined i s posted [19.11, 21.61

C. Other post ing and label ing per E20.1902, 19041 O Y O N ~ ' . .

and the l icensee i s not exempted by C20.1903, 19051 ( v r? ( ) N

Remarks :

18. RECORDKEEPING FOR DECOMMISSIONING

Issue Date: XX/XX/XX ( R I rec 'd 03/10/94)

87100, Appendix B

A. Records of information important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until 1 icense termination [30.35(g)] ("l'y ( ) N

b. Records include all information outlined in [30.35(g)](SfY ( ) N

19. BULLETINS AND INFORMATION NOTICES

A. Bulletins, Information Notices, NMSS Newsletters, etc., received by the 1 icensee

8. Licensee took appropriate action in response to (<'ON

Bulletins, Generic Letters, etc. Remarks: ~5~ rM& dokCes 7-1 +he// e ~ d * h s*$ ;dpo*-5

(f l ( N qpp*/rl:cl +e S I P

20. SPECIAL LICENSE CONDITIONS OR ISSUES ( ) N/A ,4//c

A. Special license conditions or issues to be reviewed:

B. Evaluation:

21. CONTINUATION OF REPORT ITEMS

22. VIOLATIONS. NCVs. AND OTHER ISSUES

Note: Briefly state (1) the requirement and (2) how and when the licensee violated the requirement. For non-cited violations, indicate why the violation was not cited.

M a n e ,

23. PERFORMANCE EVALUATION FACTORS

~icensee tJt/&. R e e d 4f.wv MedC+ ~nspector K: Bce.v.r (name 8 location) Inspection Date - 2 3

I A. Lack of senior ianagement involvement with the radiation safety

87100, Appendix 8 Issue Date: XX/XX/XX (RI rec'd 03/10/94)

program and/or Radiation Safety O f f i c e r (RSO) oversight 0. RSO t o o busy w i t h other assignments

( 1 y ( 4 - N C . I n s u f f i c i e n t s t a f f i n g

O Y ( + N

D. Radiat ion Safety Committee f a i l s t o meet o r funct ions O Y ( M

inadequately E. Inadequate consul t ing services o r inadequate audi ts

Y ( W

F. F inanc ia l I n s t a b i l i t y Y ( 4 - N OY(W

Remarks (consider above assessment and/or other per t inen t PEFs):

Regional f o l l ow-up on above PEFs c i ta t ions:

END

Issue Date: XX/XX/XX ( R I rec 'd 03/10/94)

87100, Appendix 6