at 25 aV.4i'e2a

12, 19194

aci all is tDate

-;ate-

~Dat~e

Brancb

• Ifl r

-042fJ6-ýf lileIhIch aed asThe,

? 31w~as~use in ~a

7Ian

-al S

oftheý

assay a iodi~ne-131 capsuleidi opharmace tj Ca mr th~an

:r~ps~h~'the 'ea sikredthe 1t1P4 iOr -i'Odtne-131 as

,stated. in:(,ed (Sect)-on

in th~e fatil

where

r-ed

sta~tionjdei'

on

'Wh that therA or signsi'a tior,

iat~ thestoreldSi~gp or,

of-the lcenseet-o~pfrobrly block and brace: packagesiny. 1 icensed mate'ri.4I in-4ccordance ~with 49 UFR Part

() Sect'ion ]11

: , .. ,. .

tiiients (jSections '6 and 7)

rmed' of all oDf jthe ,omnitsn'ents iý,adel?rapced int. icense (Secboi~s

"t a•a]I tti. es 4i .to a fa ol•tyor 'of the nuc-lear'pharrnacy ý(Section

" 'I-.- :•.:i•

C.[ :.••..: -;

.. .7".:;; ::.z ::. :: :. .......!•(i.:i:...

2 -

rjm ~an 1:1 y, :1 d

RW Ds?

A UP,

-receivE

-at the--

compl1iance 'With ie Cifi 2i0.106-() P* wn-estritted, areas- An inspect'ion pel*noltdety any NPC vtlations.

~od ine - 3/x onan-23 reff%,ent~s tolvre n ~Jaruary 14, 1991, did'

D ~cembe~ 22,. 1993, i~der.ifledIre of ý Ikensee to iveri fy tiiat tthetteilpt Of the. type, andIpricr toD trpf~erring

~pecti~eifiedan

~y s'elf ide~ntifi-d, bu4 notto -descrfibe a~t io-ns t2-kcn lzt

weakpesse~s arapoit.

4._

4>..

grglan ization ~and[Adrinini strat~ion

Mr. Waren~ Fabling, is the corpotorate snanagEy -of s4c 4agnServices {DIAS) and Nuclear~ Medical Associlates~ Reporting toMy-, Fadling at thecor'por-ate office is M4r, Dennis Davis, t~he -managerresporslbIe for DIS, Mr. Miriha'el -rawbuirg., R~-P*: is the Manager ah4'Radiat ion Safety ~Officeer (R50) ~at the W~arren Pia nZCy and reo~stoIr2- Davris, Mr. Grawber-q is also The PSO of analtir all inckrod' T C Eapharm~acy, located ini Sa in~aw Micbigan.

5...Padi~ation Safety Pr-.-rai~. .

The- inspectors r-ev iewed the cons~ultant's reports of rad~iophiarjn4cY audits*-4ated 3/31f94 and 6/J23/94, 'Two self i~dentified T-incomoý p-ace -temscon~cening, transportat ion issues were noted, inr the consultant's report,d. ated 06,23/94. 1 ma 1letter dated !aqV7L"94 from the RSOt iCie

Dpný S r~~i, ISOperat ions Nanager, the 'RSO -bri efly d iscussed -n"itemis of concern' and' indicated torrective action. The RfS-O did not .

address the root cause of tei~nfractlons.

This ýs contrary to the coimet 4r tn e Icerisee's lettei- daiedMard Z, 1994, in respons~e to ~the February 4, 1994. eoiý o ilation)and area of concern, tthat internal, audit, finding responses would be-comrnunicatedý to the "corporate Operations Manager in the -form of an NMIAAueitRepnesýntawthn3dV that recs~e4~d-i~ueivang 'Li~e irnal audit

repot~ad tat he espose oul inlud anas-sess-menit of- root cause-of tIhe deficiency. --

*We. therefore continue to be concerned that an effective se~lf- -

assesmentprogram is not in place as evidLnced by the fact that:*-there is no assur-alceI (.1) rthat root Lauset of- problems -are

thoroughly evaluated and lasting correc tj.ve -actions are *

<identified; (2) that c-orrective actiovns -are, mplemiented, and(3) thalt corrective actions are effective- to.-prevent recurrence_Other more direct evidence that, do: ffbtiv. .. so`f-asses sment-programn is not irM place is the-I ap0 pren 0iltos-ietf

5

in t0i ýnpc~nnn f vigr~t wev fdemti2byTeicee

Ove 'are of conc~ero wa&. idenijff ilod

yispe~nsiria of aio rceavs

-0-n f~c g2 1954' a $flwtin istr4tpt 4~~lda another' i ~~eloiw.'s in part, ca4$&eby ibe -mis0abdipgA of..~ an ipMO-3 ap"t pioby thi s Ilen' theý nisadwmistr`tit 0lele 1 hnaSwcoui

dia~$ic <as~lS~as aDinlerN- to aiftidividt0alwh-en te<reýcal l-ed A a oitS pueuefr' fci~g tes $hsart o0ae iodneP4 0.1tsM 1e$

It1 wa's &dteutS'ot thAt at 'the tiu 10f 't S Aad iwtsrao paaytechnilians wer# 'rou ,iaie& iimstrouctd to -filprsitotsw otýdirect loversig-ht by fle ailt4ýýriz7ed nsert A711na ebmin h-had 'be"" aitydpr~n2 s 4"tcoure butwo 'hal rorrked as ýatecbfiicitn 'for 1brit Yearas anis4talehy flleýd a -pescriptt, Vit -a* $0 -mictocurke 'iodi~e-j31 caps~W .uirsat-AI. of thle, 'reojed:0 i~ui

~oblt-t~~on~g~ptauaion@T~ asn, fOr tlheminsýtae as thatjieriawp~s7J~ va -Mjsýtr~a4b4e turirqg it5 Ifw~ fitn hepsciton-du&I-vi conyem tjoh-wi coo*0r** -V sttdt npcorsi

ee, ail&Th4Aie Mi not, $sa tte~aps pnr tor10 " uWlnq ItInto thfe WaTded ;ctbtaioen vhigibýo thteaj w label. an i t

AlthoughW 'T e' d ldtnapstatped ti#, th41 -nt aga t jl "dOne ~or, taf iil,11g, tie t 'prj,ýrpt Ioan;ti fjlle,0E 'Out the box:400 o Dr t e srec rpilabel e4:a tti VAty~ds~ d I4n: bx heS wr.te I 03ptl. vhepananf~attuce'rs-&ssay on, Zte pretsriptiou 'w&s tye _Yi cowaiteradth

rnnbetr was x1 s, 48 pc#c6 . :'h#atcs n ty ath 'keof- h i~nt eiW-tat.e4' that he thougit that the techniia bad as-Ve h

,capsul'e because thw taxl was '6Tmit'~i eaýsnw hte 44i -ntbiecau'se5044mcroeari4 :ibdine-1f31ev~uld fln read ýapproviviately54

ý pebatutMatC~'$t' 'on 4i'ty stat4- that: 0, -was bis -!nderstandingath Ueofthie4n t ppcr eva 'to :assay: 405 do pirto

s'pnsi~$o tergflt~th thiiit' nbelfieved 'it 'was --oiec-essary 1 -Zin'dtleISsaedht t heyle- t ssacobal t-S1'prio o ipnsn.lbhe kso PStated th ttet~igm f Thncetde it: - corec-t to fil

ot 4L the kct ivi1:t y .s'pens~ed box 'with th'eý aount prinpted 1,,v compoter i Athe -as say box. Thie .pharmacist on duýty..Al the t:nieOf the incidentstated t~hat the box' should have been' lft, bl6ank if -noý assay Wa 5nd.ý

Ivhen the capsule waS 'received 'by, thelc' optl tetcnlgs;real izing that cobalt-K57 cap4sdjes are, .nM.na y blue -and: hite 'and. that.the Capsule~rer&iWed -was wit 'y pke tob a: -diate tchnica amhp pharnacy. 46h reti yed -thie i nf omato Ito ma radiloph .andacst.. After.

repei~g he lot nurriber, tbt'e bnd-ogist wa infone hadupedsed doisagel -as-cobalt-SI bu t-ha the Wrong Mlnwbetr Written On it

and was q~p i ,e 4 cbrrectedO n;ube for th e o~b al t -ST. 6A co tritin

.. t the TO em wa:s t -t 'I" tot niuntrs •r -oth . •p. . .. nd..inAt% 11);, Thformation11 T4n the coorcoding 1v eac n o oiaThe::i::• •!::' tech&•o•s at-te hosp!•al Qi:n asayed the c•_u.e. Th

number -0W wS psemO~t ~C t~a~4 Sru' uus rov 4e4-by Thle iotcleay pbaitsacy that. tjw' numbr :to'ini4e ~vith the -iesrecor4 jattewtion 41as not Anrr~ te dcimtai Ponet oct .Th

* h h~c ar*re tt*orndTd h Itnsu4r to I1t

o-,O~ng unce vn error'ha Otcjwret.

T~he: -teqheatfaio 'was ofrn~ th'e 47 4stske 0And llmediae ~ia el Ple 4 r *.-I, j~o ythe RS Att rvassii ea,,I 'n 1ý Ccolwier 4 ~ ebeunl$ esb're4 .SOu ra~p~hr~ c$Pcrd 4d41qI

item 1& W 0t Ah s'Daoth ia~o eeene n loit-¾i -.. .44e Th uI kn.. ei-led :Sa.I. tb:" s r Saf U.e . lt" .ctiv

'{ ' .. .} •"" .'.: : = :-:.'.: .• :• -,-[ . ;.i•.'..T-_ ,.: ::°-•, ,°:. - . . . . < t.. .. ,. :. .. ... =. . . .... "a . .• .. •

.te- e aand c. ..... . . . .. A T;r4

be caj..1.5 unicrorie s 'Ofe!of o.ire-.3,•e a•

• .i$ i # ..h.res. ed.&ftttcbniian t

a'rttinu

Train and _supervise the dispýensloqaan errot miade by hat.

i enappOcapifinof writtene .ater.ia an~d••.ai.. •.ftentimi y •a cusme. ..

ts.. ane were

.tnnit.nr••• f. A.irff a)ffu• •-...... •.•,- - ... •'--• -.•.--.

I•. hg t.hen•.•-sit .inspecti. th.e, spectors attempt.ed to •am.nereco_,rds rel ated to* the iodine413i n xeno-3 lv bxehutRSO v'as w• able to produco e the reacobds rquested rat t.ha't e.Subsequent to the ponsite. cJis.,.e•,spect•fm e ds weireprovide&ý It Was- deote rmined: That contrary to st~atements vade .. ...I 'a.:ý. 1 1-later -dateid Septeniber 25 9 eerne in Condition 29 ý jof the

The

7

• '..1

isions :sincie.Januarv 7-

irborine 'r.-Aoacts of~ the ýpub i Cý

'ty

I. .Factors

ni adeannears

,and One

uS wsnawareo;fpt

-area 'of cOnc'ern ~was

~Count ~iig

4:*-

pparent ~i oation-,of ý:NRC-reqirements was

a: actor s

i..entife.. :0.

)ot cause:f, -of thistprob.em ap p, earsto' beand I&SO oif -he commpitmnents jae -in I-.e

1ack Ifl'f k-nmdwledge ,by. th~-icens ap uitJ. 1i.

v io l. tz ion ý)f IM Cflq-s' ewtswas i ent, l e4 ,

e of this vpile~tyofltion'appears to- be -anotheriwas niot aware eof tertaein lica-nse co,,,,tmait Is~

-•i ••...•~ ii• •• ' ••• ii . •S•

ticeuse t iiv kst'ates Oth I 4'pen* _1t1ato litdIn jtbi.,i6AX, and -6it shaiI be t0sed by JfDd a eliero y olvul

.. i~~-r~nr v tt, LNM Se tt., A~ _.C. .afl&7t Of..

$ai~~~~~W IcCot;it 4edc1 Thit rttt.Acrrt1js-o3ttborized Asers jnaed On 00,cen 44-4Jf--0f* n'lb 'tflo4btbt l irt~t'se frot 4nspiecttto 1041ou~ssp,M

-, Augos~t 31,s 1W94 the llrcnsetviihype4terii Mit. i~tbtm C6AG,_ f or,-n~ ~~ iijf1 e tAu tbiz ..e list,botwevzr, the lite~eddze ~f1 A.. The iivido 4s istbe lst ant en W~-4 rtei~~t~l~s#aet a e te

stk t*te-ispoctors4.ý

- 7. •D it an g• •..airrint Vi Co.dition . .B of The ...c .. .... .....

0s* 00pren s6atof Iw e- lqtrsns sietfed.

IThe raot (acs AUS thi appaien ~rOln ianteeE4VWIhstthe,

7 t# nQ fltto awae o *LA-ens OWMWA

0ýthe. aay ofthe inspertio~ OtiW lopcoster ~ o~~ietactto the ficvy*t~u 'sottcoe t e doo badifca cutwtlfly.10'Lkd ._af tebr, its i'st ýUset h zpcor aeýet :a, k ITe "ay-..- .. -vw "a.... u .. .V....

... . . .- :. ...sii..ort....- .it.:k..:." o served- t"t• .iw..e ."osig'17.t th

CtotheMU.en to Thce -hb Woaov~2p oetAt.ttM. hen~

pt rstnwe1 ts-ineters"' 10 XItffO ~#3 Ta)r rel tOat the i iterse l t'ectrdaion ra-tatvpiuusgp.o rbeipg th

01 Aarph CT.J.1.4•..:< ... •.....:.i' A i&'.....j.. s 1 .•. a• . t .etoit..•.)•i..Rad•aicA.'A• .• .. ..h....:.

V 4Is'. j

.7~ AT acnesiviul 'e I~ I n4¾iuli k radiatialescod ~

ho it .30 ctent ...ete.s 4fi raiq frow5 any -c-0%r -"Cuton waiaio ke0' t h4a fte pýcit h-. -~:tj - -o-ot..n1 sy :a f a:,str n td.i"..y- . .t:cfrm.... ..et %a eaI . e. y.. . ..

- oret rm ay srae ta th -3laio oener-ai sti aiý

be rn te iots t t.t, R d tcn Ae4 -i "n :oltnt .ohto -of :..•.•i.:::-17 !in•... q:, ,.l s .ý-e tt ~ ... et .J..... -.-

- eces u f- thJJ~~2410

SO ..U::a .v Su"!:":..- ia e' >.vfi tb!i"

be aA aA. 4`0-. '. r jis- an..:..

10 CR 20-1902te) requires that the iensee-- post each-area or o... in'Which, there is upsed or stored speci~fi-ed-anoun~ts obf licH ensed& matferial

wiha Conspicuous signl or siqn~s bearinqg ~ .~ tel radiato sybol and !the'words `Cautio, Oadioactive $atertals) I r 'Oanger Radioacti~ve.

.194, the:. enrnce to, 'te nucler p a laboratory an.ila. .. : ./:;;.: On .,...' : e t m~ Ii!•,), r hamac.. ,ad, :• e. •)• S i .

area in .which: 06cfie amounts of li•ensedmiwas not posted as required.. Failure. too ah area. or room -Iit -WhIch.there is ased ors stiored. sneci f-Ied amountsfý of litensed; bateial1 wit -a'cqnspjuotýss16 1.r sign bea~ ~ -radia iosmbol. and thie-_?Words

~~n. Iparn vikn 6 i1 F 2O~.12e.91 Causa fat ors~ 4t.er l 6_I~o r:RdW~jeM~11

Therot au f ot ite: apparen V Iolations ap~pears to be an

pOvrsiqh by teR

The 'nspecors nted tat th ain, erance dor s easily opePe

-ecaiust of t-e si.ght.wari.g. of th.. otom..-door frame, thus the door .was not f:..y enqgaged4.by. the.. lectionit l•ck through -the security

By:. eirt. th.i.n t nl.sp•pection, wien .the:, rece pjoni .st waI.as :n o.t present in•n ..the fron't ffe, .ea:: person col.4 gain- entrance to the re stricted -.areas.-:,of the facility becausethe -secoi.d d or to the restri tedarea i._U sua IlIy in the 40eni posit ton during businvess hours:, Tber efore., -thes.ecuirity of Ote fici ities".urig.- certain times. is. .noted as: :anr..:ea.. of

Two apparentI..• ..- :..O.s o .ftI.requIrements -and one .area..f concern wasidentif ied. .

Tr-ansaportatiot)

49 .R part-.4... P d) requires -that k a.es ctaun nmaterial, bes l oce an rcdtat tey cannIOtchange ýpositionduring Co-ndItions nlormall n ciett rnprain

The i. npe"rs. . obse:rvedd.u ring " .. . e. insp. etion-tha. "t to the-. above, on S.te.be.r 9... : ..4ee ot bl.oc an.d. b

daily siPMmnt 'of radl opharvaceujticaIs I.nchd.ing li censed.materials. containing Approximately .55minitmries of technetm..;-9.... so that itcould not chanqe ostosi latbkvecedrigcoditionnormally incident :to transportation.. The inspectors :confitmned tltat :all

* .. of.the other. type ..vhils(vn-rsdas did -have s.atisf actoryblocking and bracig.. failure to block and ý brace:: packages ..containing..rad ioactive maerial so that":the •ycannot chanQe. position.durin.

, i normall inc to transOotation i anen ationof 49 CR Pat. .17T842(d)

•. : i ! : .. ....- .. L . : . . . " " •-"

I'~a bg<tI~4e iuispector~d6riri4' t:h& -

4'

- ~- - A' 1 "

- 4'-I '' r p

4''

'4'

- - ,, 1 '4 ~- ~1

4 - 4' '4 444-

¾ --

- 4- "4 4,/I

- '4 ' 4'

44

4 4 4 12