Text

List of Records Re Cleveland Clinic Foundation Produced by NRC Nudocs for NRC
	ML20127C403
Person / Time
Issue date:	08/26/1992
From:	; NRC
To:	;
Shared Package
ML20127C399	List: IA-92-416, List of Records Re Cleveland Clinic Foundation Produced by NRC Nudocs for NRC; ML20127C398; ML20127C403;
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	FOIA-92-416 NUDOCS 9301140190
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APPENDIX A

!~

THIS DOCUMENT WAS PRODUCED'DY THE U 5, NUCLEAR REGULATORY COMMISSIC!

NUDOCS OPERATED DY-.

STATISTICA, ' I NC .

l bNDER CONTRACT'NO.- NRC-39-Ed-E1 I'

a rs 9301140190 920826 PDR FOIA s-RUMPF92-416' PDR t

j l' . . . . _ . . . , . . - . , . _ _ . . . - . , . . _ _ , . , _ .

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.8/20/92- -FAGE :1 U. S NUCLEAR REGULATORY COMMISSION DCS' PARTIAL RECORD FORMAT REPORT 18111110784 ~

IE Insp F2ndings U Licensee Ack dtd 811028- of Licenses 34-00466-02 & 34-00466-03,Insp finding s: no nonc omplianc e noted.

FROM: DURGIN,R.E. Region 3, Ofc of the Director (810301-820201)

TO:

-ISSUED: 811028 AVAIL: PDR 1p. DOCUMENT TYPE: TIIFLA FPAC: 8111110784 TASK: ODID: DIN: IFLA-811028-02 DPN: DRN:

DOCKET NO: 03000394 03014577 FICHE- 10603 061 10603 061 RIDS: IEO75 8204000127 XA Informs of 820317 misadmir a stration of radiopharmLPatient

-injected w/bO UCi Yb-169 DTPA Instead of 500 uC1 Dose inadequate for cisternography exam & will have to be repeated.

FROM' COOK,S.A, Cleveland'C12nic Foundation, Cleveland, OH TO: COOPER,J. Region 3 (Post 820201)

ISSUED: 820324 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 9207150108A

. T ASK: ODID. DIN- 820324 DPN; DRN: q DOCKET NO: 03000394 FICHE- 62546 006 62546 036 RIDS:

8204120371 PNO~III-82-035 during G20312-18, patient received teletherapy administration resulting in total dose of 3,000 rads to i pelvic area Total prescribed dose for treatment period should have been 1, 500 rad.

FROM: SRENIAWSKI D. J. Rog:en 3 (Post 820201)

TO:

ISSUED. 820407 AVAIL- PDR 1p. DOCUMENT TYPE- TIPNOT FPAC: 58204120371 TASK: ODID: DIN. PNO-III-82-035 DPN: DRN:

DOCKET NO C3000394 FICHE: 12639 052 12639 052 RIDS: IE34S.

8704290249 Partially withheld ite informing of 820310 misadma'istration of radiopharm Patient dose pretcription missing from chart &

patient given wrong dose.Cevsed by physician _ error.

Procedures te doses reviced Related info enc 1.

FROM: -RODRICUEZ,A. Cleveland Clinic Foundation, Cleveland, OH-TO: SRENIAWSKI,D. Region 3 (Post 820201) _

. ISSUED; 820420 AVAIL: DDR 15pp DOCUMENT TYPE: CLINC FPAC: 18704290199BAr

- T ASK: ODID: DIN: 820420 DPN: DRN:

DOCKETfNO, 03000394 CICHE: 40732 042 40732. 056 RIDS:

8704290249 XA Partially withheld Itr Informing of 820310 misadministration of radiopharm.. Patient do se prescrip tion missing from-chart &

patient given-wrong dose, Caused by physician error, Procedures re doses revised.Related info enc 1=

FROM: RODRIGUEZ,A. Cleveland C1tnic Foundation, Cleveland, OH 4

TO: 'SRENI AWSKI , D. Region 3 (Post 520201) _ _

I SSUED: 820420-AVAIL: PDR 15pp. DOCUMENT TYPE: CLINC FPAC: 9206180358A TASK: ODID: DINi 820420 DPN: DRN:

DOCKET NO: 03000394 FICHE: 62105 111 62105 125 RIDS:

p I

l-f

. . . . . . ~ _

O/20/92 PAGE 2 U S trJCLEAR REGULATORY COMMISSION DCE FARTIAL RECORD FORMAT REPORT 8704290249 XC Partially withheld It" informing of 820310 misadministration of radiopharm. Patient dose prescription missing from chart &

patient given wrong dose Caused by r- h y s i c i a n error.

Procedures re doses revised Related info encl FROM: RODRIGUEZ,A. Cleveland Clinic Foundation, Cleveland, OH TO- SRENIAWSKI,D. Region 3 (Post 820201)

ISSUED- 820420 AVAIL PDR 15pp DOCUMENT TYPE. CLINC FPAC: 9206180358A TASK: CDID. DIN: 820420 DPN: DRN:

DOCKET NO: 03000394 FICHE: 62105 111 62105 125 R IDS:

8403080175 Confirms 820416 telephcne egreement that EL Saenger will ~

assist NRC by serving at medical consultant te misadministiation Findingc h conclusions requested within 30 days cf completion of adv.scry Erfarts FROM: KEPPLER,J G Region 3 (Post 820201)

T O: SAENDER.E L Affiliation Not Assigned ISSUED. 020423 AVAIL PDR Opp DOCUMENT TYPE- CLOUT FPAC: 8403080016A TASK: 0D10 DIN 820423 DPN: DRN:

DUCKET NO 03000394 FICHE 22577 143 22577 165 RIDS:

E103000215 IE Insp R";& 30-3 W 4/82-31 on 823413-14. VioIation noted:

fa: lure to perform tv11 caaite usan; derimetry sys calibt by NBS cr bo regional c i: : tbr lat fROM MULLA!ER,J R R e ( i c <Dost S20201)

TO ISSUED 820 'OR AVAIL 'DR N;,I DO C U'iF NT "vPE TIINSP FPAC; 8403080016A TASK ODID DIN 30-00374.'82-01 CPN: DRN.

DOCKEi NO 030003 4 FICHE 2 2 ?? ' "' O 1 22577 346 RIDS eaO3OROiOG D: :us 9E IE In?p Fept c .' -OO3 7 4 / E2- 01 en 820413 ?s 14 ?-

f or ward s notice of .icistion FROM NUGELIUS,C.E F-gion 3 (Pos* 820201)

TO: KOIECER J C ! n - land Clintc Foundation, Cleveland, OH ISSUED- P20721 AVAIL -ER 2pp. DOCUMENT TYFE- CLOUT FPAC 8403080016A TASK. CDID. DIN: 820721 DPN: DRN.

DOCKET NO O XOO394 FICHE. 22577 310 22577 319 R I DS :

3403080211 Notice af v 1 t 1 a t I ar, frcm in:p on 820413--14.

FROM: NOR EL : US, C E 0;. of En tgency P r e p a r e d r t; ; : C Operational Support. R3 TO:

ISSUED. 820721 AVAIL. PDR 1p. DOCUMENT lYPE- TINVID FP AC: 8403080016A TASK: ODID: DIN: 30-00394/82-01 DPN: DRN:

DOCKET NO. 03000394 FICHE: 22577 320 22577 320 R I DS:

amii

o ___ - _ _ _ - -

= .

j S/20/92 _PAGE 3 UL S.-NVOLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 8209150260 Responds to NRC.000721 Itr ce violations noted in IE insp of License-34-OO466-02. Corrective actions:electrometer calibt 820209. Extension of time will be requested-if instruments cannot be calibr before deadline.

FROM: HORTON,J. Cleveland Clinic Foundation, Cleveland, OH TO: NORELIUS,C.E. Div of Engineering, R3 ISSUED: 820812 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC- 8209150259A TASK: ODID: DIN. 820812 DPN: DRN:

DOCKET NO: 03000394 FICVT: 14884 344 14884 346 RIDS:

8209130259 Ack receipt of P20012 ltr informing NRC of steps taken to correct violations noted in IE insp of License 34-00466-02.

FROM: NORELIUS,C.E. Div of Engineering, A TO: KRIEGER,J Cleveland Clinic Foundation. Cleveland, OH I SSUED: 820907 AVAIL: PDR 1p.- DOCUMENT TYPE: CLOUT FPAC: 8209150259*

T ASK: ODID. DIN: 620907 DPN: DRN:

DOCKET NO 03000394 FICHE- 148E4 343 14884 346 RIDS: IEO7S ,

G312050209 Discuties IE insp of Licent+s 34-00466-01,34-00466-02, 34-00466-03 6 34-00466-04 on 631117 5 forwardt notice of violation FROM: SRENIAWSKI D J. Region 3 (Post 820201)

TO: PAVLICEK,W Cleveland Clinic Foundation, Cleveland, OH I SSUE D: 831129 AVAIL PDR 1p DOCUMENT TYPE- CLOUT FPAC: 8312050269*

TASK ODID. DIN- 831129 DPN' DRN:

DOCKET NO 03000394 03002649 03014577 FICHE- 21091 195 21381 196 RIDS: IEO75 6312050264 01 Discusses IE insp of Licenses 34-00466-01,34-00466-02, 34-00466-03 6 34-00466-04 on 831117 & forwards notice of violation FROM- SRENIAWSKI,C.J. Region 3 (Post B20201)

TO: PAVLICEK,W Cleveland Clinic Foundation. Cleveland, OH I SSUED: 831129 AVAIL- PDR 1p DOCUMENT TYPE CLOUT FPAC: 8312050269*

T ASK: ODID. DIN: 831129 DPN: DRN:

DOCKET NO: DE000394 03017931 FICHE 21381 195 21381 196 RIDS: ,

8410310066 Application for amenas to Licenses 34-00466-02,34-00466-03, 34-00466-04 & SNM-1659, authorizing SJ Aron a s radiation Safety officer. Fee paid.

FROM: ARON S J. Cleveland Clinic F c. u n d a t i o ni Cleveland, OH TO: Materials. Licensing Dranch _ . .

I SSUED: 840310 AVAIL: PDR 26pp. DOCUMENT TYPE: TLAMBL FPAC; 8410310046B-TASK: ODID: 77295 DIN: AMDL-840810 DPN: DRN:

DOCKET ND, 03000394. 07002213 03014577 FICHE: 27228 129 27228 154 RIDS:

r- _

. . =- _ _ _

'O/20/92' PAGE 4-U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL' RECORD FORMAT REPORT G410310066 01 Application for amends to Licenses 34-00466-02,34-00466-03, 34-00466-04 & SNM-1639, authorizing SJ Aron as radiation safety officer. Fee-paid, FROM: ARON S.J. Cleveland Citnic Foundation. Cleveland. OH TO: Materials Licensing Dranch I SSUED: 840010 AVAIL: PDR 26pp. DOCUMENT TYPE: TLAMBL FPACf 8410310046D.

TASK': ODID: 77298 D I N :- AMDL-840810 DPN: DRN:

DOCKET NO'. 03000394 03017391 F ICHE: 27228 129 27228 154 RIDS:

0410310046 Amend 16 to License 34-00466-02 for Cleveland Clinic ~

Foundation, authorizing SJ Aron as radiation safety officer.

FROM: HOLT,0.J. Region 3 (Post 820201)

TO:

ISSUED: 840822 AVAIL: PDR 1p DOCUMENT TYPE: TLLMDL FPAC: 8410310046*

TASK: ODID. DIN: 34-00466-02 DPN: A16 DRN:

DOCKET NO. 03000394 FICHE- 27228 126 27228 154 RIDS: ML3OL -

8410310057 Forwards Amend 16 to License 34-OO466-02, Amend 6 to 34-OO466-03 Amend 2 to 34-00466-04 b Amend 2 to SNM-1659.

Document should be teviewed b all conditions understood.

FROM: HOLT,B J. Regton 3 (Post 820201)

.TO: ARON.S J. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 840928 AVAIL: PDR 2pp. DOCUMENT TYPE. CLOUT FFAC: 8410310046A' TASK: ODID: DIN. 840928 DPN: DRN:

DOCKET NO: 03000394 07002213 03014577 FICHE: 27228 127 27228 128 R IDS:

~

8410310057 01 Ferwards Amend 16 to L2 cense 34-00466-02. Amend 6 to 34-GO466-03. Amend 2 to 34-00466-04 L Amend 2 to SNM-16S9 Document should be reviewed L all conditions understood.

FROM: HOLT,0,J. Region 3 (Post 820201)

TO: APON,S=J. Cleveland Clinic Foundation, Cleveland, OH ISSUED: - 840928 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8410310046A TASK: ODID: DIN: 840928 DPN: DRN:

DOCKET NO: 03000394 03017391 F I C HE: 27228~127 27228 128 RIDS:

BbO3080227- " Teletherapy Survey Rept Following Co-60 Source Replacement Five Yr Insp & Servicing for Cleveland Clinic Foundation AECL Model 780 Teletherapy Unit."

FROM: ARON,S J. Cleveland Clinic Foundation, Cleveland) CH TO:

ISSUED: 841210. AVAIL; .PDR 16pp. DOCUMENT TYPE: TRZAR FPAC: 8503080203DA TASK: ODID: 77966 DIN: ZAR-841210 DPN: DRN; DOCKET NO: 03000394 FICHE: 29284 34S 29284 360 RIDS:

8/20/92 PACE S U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT

_S503080216

.Forwardb teletherapy survey rept,per Conditions 118-20 of-

-License 34-00466-02.

FROM: ARON,S.J. Cleveland C 11 r. 2 c Foundation, Cleveland, OH TO: Region 3 (Post 820201)

I SSUED: 841214 AVAIL: PDR 1p. DOCUMEN T TYPE: CLINC FPAC: SSO3080203C T ASK: ODID: 77966 DIN: 841214 DPN: DRN:

DOCKET NO: 03000394 FICHE: 29284 343 29284 343 RIDS:

8503080221 Forwards teletherapy survey rep 4,per Conditions 18-20 of' License 34-00466-02. -!

I l

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: Materials Licensing Dranch ISSUED: 841214 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8503060203D- i TASK: ODID- 18464 DIN 841214 DPN: DRN:

DOCKET NO: 03000394 FICHE: 29284 344 29284 344 RIDS:

8DO3080211 Submits addl info re 841210 teletherapy survey rept.-in response to 850121 request. Individual continuously present for one yr would not exceed 500 mrem limit. Record of B50121 telcon enc 1.

L FROM. ARON S.J. Cleveland Clinic Foundation, Cleveland, OH TO: . ADAM.D Region 3 (Post 820201)

ISSUED: 8S0123 AVAIL. PDR 2pp DOCUMENT TYPE: CLINC FPAC: 8503080203B T ASK: ODID- 77966 DIN 8S0123 DP N:- DRN:

DOCKET NO 03000394 FICHE: 29284 341 29234 342 FIDS-8503080203 Amend 17 to License 34- OC 4 6 e.-02 for Cleveland Clinic Foundation, amending Condition 2S re possession & use of licensed matl.

FROM: ADAM,W.J. Region 3 (Post G20201)

TO:

ISSUED: 850212 AVAIL: PDR 1p. DOCUMENT -TYPE: TLLMDL FP AC : 8503000203&

TASK: ODI D: DIN- 34-00466-02 DPN: A17 DRN:

DOCAET NO. 03000394 FICHE: 29284f338. 29284 338 RIDS: ML3OL 8503080207 Forwards Amend 17 to License 34-OO466-02. License conditions

-noted, FROM: ADAM,W.J, Region 3 (Post 820201)

TO; ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 8S0212 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8503080203A TASK: ODID: DIN: 8S0212 DPN: DRN:

DOCKET NO: '03000394 FICHE: 29284 339 29284 340 RIDS:

, . . - . _ - ~ . ._

. . - - . . . . g. - - . - , , . . . . . . - - . . - .- . . .

8/P0/92 .PAGE 6 V. S .- NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD' FORMAT REPORT 8511270187 Notifies of new address to ensure delivery' to correct

' location within foundation.

'FROM: ARON,S.J. Cleveland Clinic Foundation. Cleveland, OH-TO: STANSBURY., T. R. NRC - No Detailed Affiliation Oiven ISSUED: 850924 AVAIL- PDR 1p. DOCUMENT TYPE: CLINC FPAC: '8511270184A TASK: ODID: 79941 DIN; 830924 DPN: DRN:

DOCKET NO: 03000394 03002649 03017931 FICHE: 33646 103 33646 103 RIDS:

8D11270187 01 Notifies of new address to ensure delivery to correct location within foundation.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO; STANSDURY,T,R NRC - No Detailed Affiliation Given ISSUED: 850924 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: BS11270184A TASK: ODID; 79943 DIN. 850924 DPN; DRN:

DOCKET NO- 03000394 07002213 FICHE- 33646 103 33646 103 RIDS:

8511270187 02 Notifies of new address to ensure delivery to correct location within Foundation.

FROM: ARON.S.J. Oleveland Clinic Foundation, Cleveland, OH TO: STANSBURY,T.R. NRC - No Detailed Affiliation Gi v en ISSUED: 850924 AVAIL- PDR 1p. DOCUMENT TYPE CLINC FP AC : 8511270184A-T ASK: ODI D: 79942 DIN. 850'24 .DPN: DRN; DOCKET NO 03000304 FICHE: 33e4+ 103 33646 103 RIDS:

SS11270387 03 Notifies of new address to ensure delivery to c o r r e t_t location within foundation.

'FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: STANEBURY,T.R. NRC - No Detailed Affiliation Given ISSUED: 830924 AVAIL

PDR 1p DOCUMENT TYPE: CLINC FPAC: -8511270184A

-TASM: ODID; 79944 DIN: 830924 DPN; DRN; DOCKET NO: 03000394 FICHE: 33c46"103 33646 103 RIDS:

-8511270195 Amend is to Licente 34-00466-02-for Cleveland. Clinic = -

Foundation, changing e d d r e s s--

FROM: MAT SON, E. R.- Pegion 3 @ce t 920201I TO:

ISSUED: 85110S AVAIL: PDR 1p, DOCUMENT T YPE: 1TLLMDL FPAC: 18S11270195 TASKf ODID: DIN: 34-00466-02 DPN: A18 DRN:

': DOCKET NO: 03000394 FICHE: 33646 299 33646 300 RIDS: ML3OL i

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8/20/92 'PAGE 7-

- V .- S: NUCLEAR REGULATOR COMMISSION' DCS PARTIAL RECORD FORMAT REPORT-

- 8512240052 Discusses safety insp of Licenses- 34-00466-01 & 34-00466 on 851205 & 06 & forwards notice of violation. Actions described in 831205 Itr te apparent items of noncompliance

-found during 831117 insp examined.

FROM: WIEDEMAN.D.G. Region 3 (Post 820201)

TO: EVERSMAN.J.J. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 851220 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: :8512240052*-

TASK: ODID: DIN: 851220 DPN: DRN:

DOCKET NO: 03000394 03002649 FICHE: 34030 226 34030 227 RIDS: IEO7D.

8601310039 Ack receipt of 860107 Itr informing-NRC of steps taken to correct noncompliance noted in insp of Licenses 34-00466-01

& 34-00466-02 on 851205-06. Daily sur vey of hot lab & program not included in 790719 application. Noncompliance volded; FROM: WIEDEMAN.D.G. Region 3 (Post B20201)

TO: -EVERSMAN,JLJ. Cleveland Clinic Foundation, Cleveland, OH I SSUED: 860128 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8601310035A T ASK: ODID: DIN: 860128 DPN: DRN:-

DOCKET NO: 03000394 03002649 F ICHE: 3442e 320 34426 320 RIDS:

8GO1110449 " BASEMENT FLOOR PLAN NUCLEAR MEDICINE HOSP G WING."

FROM:

Barber & Hoffman, Inc.

TO: Cleveland Clinic Foundation, Cleveland, OH --

ISSUED: 860324 AVAIL. PDR 1p. DOCUMENT TYPE: -DDDRAW FFAC: 8601110371B TASK: ODID- 83159 DIN- A-1 DPN: DRN:

DOChET NG' 03000394 FICHE: 39260 001 38260 001 RIDS:

8611250476 PNO-III-86-13S on 861006-08, patient mistakenly eurosed to 2,000 rads instead of prescTibed 1,200 raos during Co-60 treatment for blood disease. Caused by personnel error Misadmini stT ati on will be reviewed by NRC.

FROM: WIEDEMAN.D.G. Region 3 (Post S20201)

~ TO:

, I S S U E D -- S61117 AVAIL: PDP 1p. DOCUMENT TYPE: TIPNOT FPAC: 6611250476 TASK: ODID: 52FR36942 DIN: PNO-III-86-135 DPN: ~ DRN:

DOCKET-NO: 03000394 FICHE: 38716 230 38716 230 RIDS: -IE34D B611250476 01 PNO-I I I 135: on S61006-08, patient mistakenly exposed to:

l2,000 rads instead of pretcribed 1,200 rads during Co-60 treatment for blood disease. Caused by personnel errcr.

Misadministration will-be reviewed by NRC, FROM: WIEDEMAN,D.G. Region 3 (Post S20201)

TO:

ISSUED: 861117 AVAIL: PDR 1p, DOCUMENT TYPE: TIPNOT FPAC: 8611250476 TASK ODID: 'AC65-1 077 DIN: PNO-III-86-135 DPN: DRN:

DOCKET NO: 03000394 FICHE: 38716 230 38716 230 RIDS: IE34D h

9--..- g. , , r.m . r , c-#a .y-,., , - - . -

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. -- - - - . - - - - - _ _ - _ . . ~ . - , - . _ ~ _ ~ . . . . _ ~ - - _~ - - ----

8/20/92 PAGE -8 4 U. S. NUCLEAR REOULATORY COMMISSION.

DCS PARTIAL RECORD FORMAT REPORT L86112SO377 PNO-I I I-86-13SAa : on 861118, petient who receive'd 2f000 tads of radiation rather than prescibed 1,200 rads, died,Cause unknown.NRC & consultant will review misadministration &

corrective actions.

FROM: WIEDEMAN D.G. Region 3 (Post 820201)

TO:

ISSUED: 861118 AVAIL: PDR 2pp. DOCUMENT TYPE: TIPNOT FPAC: 8611250377 TASK: ODID: SCFR36942 DIN: PNO-III-86-13SA DPN: DRN:

DOCKET NO: 03000394 FICHE: 38717 237 38717 230 RIDS: IE34D 8611250317 01 PNO-III-86-13SAa.on 861118, patient who received 2,000 rads

of radiation rather than prescibed 1,200 'ds, died,Cause unknown.NRC & consultant will review misaaministration &

corrective actions.

FROM. WIEDEMAN D.G. Region 3 (Post 820201)

TO:

ISSUED: 861118 AVAIL: PDR 2pp. DOCUMENT TYPE: TIPNOT FPAC: 8611250377 TACK: ODID' AC65-1 C76 DIN. PNO-III-86-135A DPN: DRN; DOCKET NO: 03000394 FICHE. 36717 237 38717 238 RIDS: IE34D 8712030237 PNO-III-86-135D on 851006-08, radiation therapy misadministration occurred. Caused t* y miscalculation of exposure time for each of s2x planned treatment Special NRC medical advisory board formed te evalutte case FROM: WIEDEMAN,D.G- Region 3 (Post 820201)

TO' ISSUED: 861121 AVAIL: PDR 2pp DOCUMENT TYPE. TIPNOT FPAC: 8712010271A- >

TASK; DDI D. AC65-1 079 DIN. PND-II I 13SB DPN: DRN:

DOCKET NO. 03300394 FICHE. 4366S 293 43660 294 RIDS:

8712030237 01 P NO- I I I-So- 13 50 on 5$100c-08. radiation therapy ,

mis.dministreition occurred Cau' sed by miscalculation of exposure time for each of Sir planned treatment.Special NRC medical advisory board formed tc-evaluate case-FROM: WIEDEMAN,D G. Region 3 (Post 620201)

TO:

l -. ISSUED: 861121 AVAIL: PDR 2pp. DOCUMENT TYPE: TIPNOT FPAC: 8712010271A TASK: ODID: 52FR36942 DIN: PNO-II I-86-135B DPN: DRN:

DOCKET NO. 03000394 FICHE: 43665 293 4366S 294 R IDS:

'8712030237 02 PNO-III-S6-13SB*on 861006-08, rsdiation therapy mitadministration occurred. Caused ty m2 scal c ula ti on of exposure time for each of six p l a rm e d treatment.Special NRC medical advisory board formed to evaluate caso.

FROM: . WIEDEMAN,D.G. Region 3 (Post 820201)

, T O:-

l ISSUED: 861121 AVAIL: PDR 2pp. DOCUMENT TYPE: TIPNOT FPAC: 8712010271A L TASK! ODID: S2FR36942 DIN: PNO-I I I-86-13SB DPN: DRN:

DOCKET NO: 03000394- FICHE: 4366S 293 4366S 294 RIDS:

i I !

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._._..._m.___.__..__..______.. .._ _ __ _ ... _ __ . ~ . - . . . __ _ . . _ _.

PAGE- 9 i 8/20/92-U. S. NUOLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT B704290261 Responds to G6111-8 Itr te PNO-111-86-135 concerning misadministration of radiopharm.Dased on fragmentary info from licensee, patient may have developed radiation pneumonitic & radiation nephritis.

FROM: SAENGER.E.L. Cincinnati, Univ. of, Medical Center, Cincinnati, OH

.T O: KEPPLER,J.G. Region 3 (Post 820201)

ISSUED: 861126 AVAIL: PDR 5p p. DOCUMENT TYPE: CLINC FP AC: 8704290199BD TASK: ODID: DIN: 861126 DPN: DRN; DOCKET NO: 03000394 FICHE : 40732 057 40732 061 RIDS:

8704290261 XA Responds- to 861118 ltr te PNO-!!I-86-135 concerning misadministration _of radiopharm. Based on fragmentary info from licensee, patient may have developed radiation Jpneumonitis ?s radiation nephritis FROM: SAENGER,E.L. Cincinnati, Un t v. o f, Medical Center, Cincinnati, OH

.TO: KEPPLER,J G. Region 3 (Post G20201)

ISSUED: 861126 AVAIL- PDR 45pp. DOCUMENT TYPE: CLINC FPAC: 9206180358A

' TASK; ODID DIN' 861126 DPN: DFU4:

DOCKET NO: 03000394 F!CHE 62105 126 62105 170 RIDS:

- 9206240233 Provides rept of therapeutic mesadministration involving use of clinical Co-60 source c onc er ning license 34-004e6-02.

FROM THOMAS,F J Cleveland Clinic Foundation, Cleveland, OH TO: WIEDEMAN.D. Region 3 (Post 820201)

ISSUED. 861128 AVAIL: PDR 1p DOCUMENT TYPE- CLINC F P AC : 9206180321A TASK: ODID. DIN. 861128-01 DPN: DRN:

DOCKET NO 03000394 FICHE- 62105 07G 62105 078 RIDS:

9206240233 01 Provides r+pt of therapeut: mitadministration involving use of clinical Co-60 source concerning license 34-00466-02.

FROM: THOMAS,F.J. Cleveland Clinic Foundation. Cleveland, OH TO: WIEDEMAN.D. Region 3 (Post 820201)

ISSUED: 861126 AVAIL: PDR 1p DOCUMENT TYPE: CLINC FPAC: 9206180321A TASK: ODID. DIN: 861128-01 DPN: DRN:

DGCMET NO: 03000294- F ICHE: 62105 078 62105 078 RIDS:

9207080307 Forwardt preliminary no t 2 fi c a ti-on s T e request tio assist-RIII f r sp staff on var 2cus i n t e r v a s. w t c' v e to s e n s i t i v e-nature of G61006-OG PNO concerning terminally i ll patient

-exposed to 2000 rads of rad 2ation-FROM: PAWLIK,E T Reg' ion 3 (Post 820201)

TOf . HAYES,B D. Region 3 (Post 820201)

ISSUED: 861210 AVAIL: PDR 1p. DOCUMENT TYPE: CMMEMD FPAC:- 9207080281A TASK: ODID: DIN- 861210 DPN: DRN:

DOCKET NOf 03000394 FICHE- 62273 144 62273 = 218 RIDS:

8/20/92 PAGE 10 V S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT

-8702050195- Responds to B61120 confirmatory action ltr t e Co-60 misadministration reported on 861117 Summary of 10CFR35.42 prepared L method of reporting within institution reaffirmed.

FROM: THOMAS,F.J, Cleveland Clinic Foundation, Cleveland, OH.

TO: KEPPLER J.G. Region 3 (Post 820201)

ISSUED- G61218 AVAIL: PDR 18pp. DOCUMENT TYPE- CLINC FPAC: 87020SO171A-T ASK: ODID- CAL DIN: 861218 DPN: DRN:

DOCKET NO: 03000394 03002649 F ICHE: 39512 322 39512 339 RIDS:

870205019S XA Responds to 861120 confirmatory action 1tr te Co-60 misadministration reported on C61117. Summary of 10CFR35.42 _

prepared L method of reporting within institution reaffirmed FROM: THOMAS,F.J Cleveland Clinic Foundation. Cleveland, OH TO: MEPPLER,J O. Region 3 (Post 820201)

ISSUED B61218 AVAIL: PDR 6pp. DOCUMENT TYPE; CLINC FPAC: 9206180358A TASK: ODID: CAL DIN 861218- DPN: DRN:

DOCKET ND: 03000394 03002649 FICHE: 62105 082 62105 087 RIDS:

9207210279 informs of misadministration of radiopharms Patient injected w/Tc-99m sodium pertechnetate r es t h e r than Tc-99m DTPA. Caused

.by technologist error.On 861118 dese 2nfiltrated through closed peripheral line Lines rechecked.

FROM: ARON.5.J Cleveland C11nic Foundation, Cleveland, OH TO: Regaon 3 fPort 820201)

I S S U F. D : 870100 AVAIL- PDR Opp DOCUMENT TYPE. CLINC FPAC: -92071SO108A TASK: ODID DIN' B70108-01 DPN: DRN:

DOCKET NO 03000394 FICHE' 62546 030 e2546 040 RIDS:

- 9 2 0 7 c!1 0 2 7 01 Informs of misadministration of radiopharms Patient injected -

w/Tc-99m sodium pertechnetate v.ather than Tc-99m DTFA Caused bg-technologist error On S61118. dose infiltrated through

-closed peripheral line. Lines rechecked FROM: ARON,5.J Cleveland C11nte Foundai.an. Clevoland, OH TO: Region 3 (Post 820201)

I SSUED: 670106. AVAIL- PDR 3pp. DOCUMENT _ TYPE. CLINC FPAC: 92071SO108A TASK GDID: DIN; 870108-01 DPN: DRN; DOCKET NO: 03000394 FICHE: -62546 038 62346 040-RIDS:

8901110110 Application 'or amends to Licenses 34-00466-02 L 34"OO466-03, authorizing use of licensed matl by P Higgins, C S1bata,W McCarthy,J Dlue L W RoLetts for nonhuman use-5 SJ Aron at . radiation safety officer. Fee. paid.

FROM: ARON.S.J. Cleveland Clinit Foundation, Cleveland, OH.

-TO: Region 3 (Post 820201)

ISSUED: 870113 AVAIL; PDR 23pp. DOCUMENT TYPE. TLAMDL FPAC: 8801110104D TASK! ODID: 82815 DIN: AMBL-870113 DPN: DRN:

DOCKET NO: 03000394 03014S77 FICHE: 43971 223 43971 24S RIDS:

J l

l

- . _ . . _ _ . - . . . - . . . ~ . . . ~ . . . - - . ~ . , - - - .-. - . - - - . ~ . - . . - . . . _ ~ -

8/20/92 PACE 1.1 _

U. S. NvCLEAR. REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 89011_10110-01 Applicat2on for amendt to L2eensec 34-00466-02 6 34-OO466-03,authori21ng use of-licensed matl by'P Higgins, C Sibata.W McCarthy,J Dlue b W Roberts for nonhuman use &

Sd Aron as radiation safety officer. Fee paid.

- FROM: ARON.S.J. Cleveland Clinir. Foundation, Cleveland, OH TO Region 3 (Post 820201) .

I SSUED: 870115 AVAIL: PDR 23pp. DOCUMENT TYPE: TLAMBL FPAC: _8801110104D-TASK: ODID: 82816 DIN. AMDL-87011S DPN: DRN; DOCKET NO: 03000394 FICHE: 43971 223 43971 245 RIDS:

87020D0171 Responds to 861218 submittal of new proposed radiation therapy GC/GA program. Review concluded that listed areas should be revised or clarified. Response requested within 30 days.

FROM: HIND,J.A. Region 3 (Post 820201)

TO: THOMAS,F.J. Cleveland Clinic Foundation. Cleveland, OH ISSUED: 870126 AVAIL: PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 8702030171*

TASK: ODID. DIN- 870126 DPN: DRN:

DOCKET NO 03000344 03002649 FICHE 39S12 319 39312 339 RIDS: IEO7D

, 6801110434 Application for amend to Licente 34-OO466-01, authorizing relocataon of nuclear medicine L nucleaT card 2 ology depts-per attached drawing Fee paid FROM. AR-DN,S J. Cleveland Citnic Foundatton. Cleveland, OH TO: Region 3 (Post 820201)

.1 SSUED: 870204 AVAIL PDR 6pp. DOCUMENT TYFE-. TLAMDL FFAC: 6801110371A-TASK: ODI D: 82925 DIN' AMDL-870204 DPN: DRN:

DOCKET NO. 03000394 F!CHE- 43990 188 33990 194 RIDS:

0704290276 " Cleveland Clinic Foundation Radiation Therapy Misadministration Investigative Rept FROM: ALMOND P. Louitville, Univ. of, Louisville, KY-

.TO:

ISSUED = 870207 AVAIL PDR 35pp. DOCUMENT TYPE: TRZAR FPAC: 8704290199BC: '

-TA5K: ODI D: DIN- ZAF-870207 DPN: DRN: ,

DOCKET NO: 03000394 FICHE. 40732 062 40732:097 RIDS:

1 Insp Rept 30-00394/86-01 on SS1120-e70210 violations noted.

. 0704290216 failure to make timely notification to NRC re therapeutic !

misadministration & failure to obtain approval of

. radioisotope committee for physicians to use matl, -

FROM: LASUK,S.R. Region 3 (Post 820201)

TO.

-ISSUED: 870210 AVAIL: PDR 9pp. DOCUMENT TYPE. TIINSP FPACi 87042901998

TASK: ODID: DIN: 30-00394/86-01 DP N '. . DRN:

DOCKET'NO: 03000394 FICHE: 40732 031 40732' 097 RIDS:

t . , . - - -*

'wy.g , --. - - , y..r--,gn- > - , ,.,.m m - . - -

8/20/92 PAGE 12 U. S. NUCLEAR REGULATORY COMMISSION DCS PAR 7IAL RECCRD FORMAT REPORT 8704290216 XA Insp Rept 30-00394/86-01 on 861120-870210. Violations noted:

failure to make timely notification to NRC re therapeutic misadministration & failure to obtain approval 'f radioisotope committee for physician ~ to use matl.

FROM. LASUK,5 R. Region 3 (Post 820201)

TO:

ISSUED: 870210 AVAIL: PDR 9pp DOCUMENT TYPE: TIINSP FPAC: 9206180338A TASK: ODID. DIN. 30-00394/86-01 DPN: DRN:

DOCKET NO- 03000394 FICHE 6210S 100 62103 108 RIDS:

8704220187 Forwards radiation safety incident iept te release of radioactive ashes from Intinerator r o om, r s ;- or t e d on 870206 Loss of licensed mati does not appear to be substantial hazard to persons in unrestricted a r-c a s .

FROM: ARON.5 J. Cleveland Clinic Foundation. Cleveland, OH TO: WIEDEMAN,D Region 3 (Post G20201' ISSUED. 070212 AVAIL: PDR 3pp DOCUMENT TYPE: CLINC FPAC' 0704220130D TASK ODID: DIN B'0212 DPM: DRN.

DOCKET NO 03000394 03002640 03014577 FICHE 40520 143 40620 145 RIUS:

8704220187 01 Forwards radtation safety ircident rept te release of radioat t. t v e ashes froa incineratc- i a o.b r e p c r t e d on 870206 Loss of licensed mati dees not appeat to bo ;utstantial hazard to persons in unrestricted areas FROM- ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: WIFDEMAN,D Region 3 (Pott GPO201)

ISSUED G70212 AVAIL. PCR 3pp DOCUMENT TYPE CLINC FPAC: 870422013OD TASK- DDID DIN 870212 DPN- DRN-DOCKET NO 03000394 0 %17931 0700 M44 FICHE 40620 143 40o20 145 RIDS.

G7 04 22015 tA Forwards v s. d l a t i rn , safety in: Ident rept re Teleast of radicactive ashes f r e cc. 2ncine rator rcom Tercrted on 870206 Loss of licensed mati duet n;s appear tc Lo s u b t. t a n t i a l hatard to persons in un: estt 1cted aTeas FROM: ARON,S.J CI(velanc C11nac Foundation, Cleveland, OH TO- WIEDEMAN>D. Region 3 (Post D20201)

ISSUED- 870r12 AVAIL: PDP 3pp DOCUMENT TYPE. CLINC FPAC: 9207050132A TASK: CDID- DIN 870212 DPN. DRN-DOCKET NO 03000394 03002649 0301457- F I C HE : 62262 130 62262 137 RIDS:

S7042201Ln <D Forwards r3diation aa+e ry inctdent rept re release of radioactivo ashes frem incinerator room reported on 870206, Loss of licensed matl does not appear to te substantial hazard to persons in unreitricted areas.

FROM. AFON,S.J. Cleveland Clinic Founjation. Cleveland. CH 10: WiEDEMAN,D Regton 3 (Post 820201)

ISSUED: 870212 AVAIL: PDR 3pp. DOCUMENT TYPE-. CLINC FPAC: 9207080132A TASK: ODID: DIN 870212 DPN: DRN:

DOCKET NO: ^3000394 03017930 07003044 FICHE. 62262 130 62262 137 RIDS:

U/20/92 PAGE 13 U .- S. NUCLEAR REGULATORY COMMISSION ,

DCS PARTIAL PECORD TORMAT REPORT

)

8704220187 XC Forwards radiation safety incident 'ept re release of radioattive ashes from incinerator room, reported on 870206.

Loss of licensed mati does not appear to be substantial hatard to persons in unrestricted ar e a s ,

FROM: ARON.S.J. Cleveland Clinic Foundatien. Cleveland, OH TO: WIEDEMAN,D, Region 3 (Post 820201) ,

ISSUED: 870212 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FP AC; 9207080132A T ASK: ODI D - DIN: 870212 DP N: DFU4:

DOCKET NO: 03000394 FICHE: 62262 130 62262 137 RIDS:

9206180333 Discusses safety insp of license 34-00466-02 on 861120-870210. Violation noted.Insp conducted to review circumstances surrounding teletherapy misadministration that occurred in Oct 1986-FROM: HIND,J A. Region 3'(Post 820201)

TO: KISER,W.S. Cleveland Clinic Foundataon, Cleveland, OH I SSUED: 870212 AVAIL- PDR 2pp DOCUMENT TYPE- CLOUT FPAC: 9206180321A TASK: ODID. DIN 870212 DPN: DRN:

DOCKEl NO- 03000394 FICHE 62105 026 62105 031 R I DS:

i 87022bO339 Forwards nottce of 870304 sign 2ficant licensee meeting w/ Cleveland C12ntc Foundat2on in Glen Ellyn,IL to discuss violations adentified d u: Ing Teient insp,ccrrect;se actiont

&_enfortement options available, pet 870218 telcon-FROM; HIND,J.A. Region 3 (Post 820201)

TO: KISER,W.S. Cleweland Clinic Foundation- C3eveland. OH I SSUED: 870219 AVAIL: PDR 2pp DOCUMENT TYPE- CLOUT FPAC: 9702250339 TASK: ODID DIN. 870219 DPN' DRN:

DOCKET NO 03000394 FICHE 39728 350 39728 359 R1DS: -1EO7D-8702230339 XA Forwards notice of 870304 significant licensee m~eting

.w/ Cleveland Clin:c Foundation in Glen Ellyn,It to Jascuss violations identified during recent insp,tcrrective actions

& enforcement options availab le, per 870216 telcon FROM: HIND.J.A. Region 3 (Post 820201)

10: KISER,W S. Cleveland Clinic Foundatien, Cleveland, OH ;

ISSUED: 870219 AVAIL PDR 2pp. DOCUMENT TYPE. CLOUT FPAC 920618030eA TASK! ODID. DIN. 870219 DPN: DRN DOCKET NO: 03000394 FICHE: 62105 089 62103 089 RIDS:

9206180331 Forward s Reg t on III :nsp rept ;e teletherapy misadministration at Cleveland Clinic Foundation, Cleveland, OH.

FROM: WEILiC.H4 NRC - No Detailed Affi.11ation Given

-TO: PAWLIK,E.T. Region 3 (Post 820201)

ISSUED: 870303 AVAIL; PDR 1p. DOCUMENT TYPE: CMMEMO FPAC: 9206180321A-TASK; ODID: DIN: 870303 DPN. DRN:

DOCKET NO: 03000394 F I C HE :~ 62105 024 62105 025 RIDS:

-._ m_ . . . . . . . _ . _ ~ . _ _ . _ . - _ _ _ _ _ _ _ _ . _ _ _ . _ - . _ . . _ _ _ _ _ . _

i 8/20/92 PAGE 14 U. S, NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT ;

l l

8704220166 Responds to 870126 Itr, modified by 870304 en f or c e.nent

. conference. Licensee offers to emend Licenses 34-00466-01, 34-00466-02 & 34-00466-03 to include enc 1 OA/GC statement of principles for dept of radiation therapy.

FROM: KIEER,W.S. Cleveland Clinic Foundation, Cleveland, OH TO; HIND,J.A. Region 3 (Pott 820201)

ISSUED: 870313 AVAIL: PDR 7pp. DOCUMENT TYPE. CLINC FPAC: 8704220130C

, TASK: ODID- DIN: 870313 DPN: DRN:

DOCKET NO: 03000394 03002649 03014577 FICHE: 40620 136 40620 142 RIDS:

8704220166 XA Responds to 870126 ltr,modifted by 870304 enforcement conference.Ltcensee offers to a c:e n d Licenses 34-00466-01, 34-00466-02 & 34-00466-03 ta includs enc 1 OA/OC statement of

. principles for dept of radiation therapy FROM: KISER,W S. Cleveland Clinte Foundation, Cleveland, OH HIND,J.A. "

TO: Reginn ' Post 820201)

ISSUED. 870313 AVA!L: PDR 7pp 300UMENT TYPE CLINC FPAC. 9207080132A l I

TASK. DD I D. D 1 i, G70312 DPN. DRA:

DOCKET NO. 03000394 03002644 03014377 FICHE 2262 123 62262 129 RIDS:

l 8704220166 XB Responde to 570326 lit, mod 2fied by 870304 enforcement l conference Licenset offers to amend L:censee 34-00466-01.

34-00466-02 & 34-00466-03 to include enc 1 O A ,'G C statement of principles for dept of radiation therapy FROM: KI5EP,W 5 Cleveland Clinic Foundation, Cleveland, OH TO: HIND.J A Region 3 (Post 820201)

I SSVED: D70313 AVAIL POR 7pp. DOCUMENT TYPE CLINC FPAC: 9207080132A TASK' ODID- DIN 870313 DPN: DRN:

DOCKET NO 03000394 FICHE. 62260 123 62260 129 R I DS:

8703200443 Forwards Enforcement Conference Rept 30-00394/87-01 on 4 870304. Licensee will be nottfted by separate correspondence of NRC dectston re enforcement actions based on info presented & discussed at conference.

-FROM: HIND,d A. Regton_3 (Post 320201)

~

, TO: KISER,W.S. Cleveland Clinic roundation, Cleveland. OH-4 ISSUED: b70318 AVAIL PDR 1p. DOCUMENT TYPE- CLOUT FPAC; 8703200443*

TASK: ODID. DIN. 870318 DPN: DRN:

DOCKET NO: 03000394 FICHE. 40131 024 40131 027 RIDS. IE46D-8703200443 XA Forwards-Enforcement Conference Rept 30-00344/07-01 on 870304. Licensee will te not1Fied bg esparate c. o T r c- s p o n d e n t e of N7C decision re enforcement actiont Laced on info

-presented-h discussed et conferente.

FROM: HIND,J A. Region 3 (Post 520201) 4- ' TO: KISER,W.S. Cleveland Clinic Foundation, Cleveland. OH.

ISSUED: 870318 AVAI LE: PDR 1p DOCUMENT TYPE CLOUT FPAC; 9206180358A TASK: ODID: DIN: 870318 DPN -DRN; DOCKET NO: 03000394 FICHE: 62105 090 62105 099 RIDS:

_. . _ , _ _ _ .._ - _ ,-._ . _ . . . . . . _ . ~ - _ _ . _ _ _ . _ . _ . _ _. _ .

G/20/921 PAOE 15 i U. S- NUCLEAR REGULATORY COMMISSION I DCS PARTIAL RECORD FORMAT REPORT l t

9703200449 Enforcement Conference Fept 30-00394/87-01 on 870304. Major areas--discussed: violations identified during special insp conducted-during 861120 to 870210 2n response to reported teletherapy misadministration & licensee corrective actions.

FROM: LASUK,5:R. Region 3 (Post 820201)

TO:

' ISSUED: 870318 AVAIL: PDR. 3pp DOCUMENT TYPE: TIINSP FPAC: 87032OO443A TASK: ODID: DIN: 30-00394/87-01 DPN: EC . DRN:

DOCKET NO: 03000394 FICHE: 40131.025 40131 027. RIDS:

8703200449 XA Enforcement Conferente Rept 30-00394/G7-01 on 870304, Major areas discussed: violations 2 dent i fied during special insp

. conducted during 06112D to 870210, an response to reported telethfrapy misadministration & 11tenf.>ee correct 2ve actions.

FROM- LASUK,S.R. Region 3 (Post 820201)

TO: '

lSSUED: 870318 AVAIL: PDR 3pp. DOC UMEN'. YPE: TIINSP FPAC: 9206180358A TASK: ODID: DIN 30-00394/87 DP N: EC-DRN:

DOCKET NO: 03000394 FICHE: 62105 091 62105 099 RIDS:

a 8704170034 EN-87-031 on 870415, notice of violation & proposed

, imposition of civil penolty in amount of $2,500 will be issued. Action based on failure to make timely notification of misadministration ?. unauthortred user of matis

.FROM: FLACK,E. Ofc of Inspection & Enforcement, Director (820201-87041 TO:

ISSUED: 670410 AVAIL PDR 1p. DOCUMENT TiPE' TIEN FPAC: 8704170034 TASK: ODID. DIN: EN-87-031 DPN: DRN:

DOCKET NO 03000394 FICHE: 40586 070 40586.070 RIDS: IE33D

, 8704220130 Forwards safety Insp Erpto 30-02649/D7-01,30-00394/87-01, 30-14577/87-01.30-17931/87-01 & 70-3044/57-01 on 870323-25 &

notice of violation. Con;stn re mgt control syt expressed h improvements requested.

FROM: AXELSON W.L. Region D (Post G20201) i TO: KISER W S. C:eveland C11nic F t.u n d a t a o n , Cleveland, OH f

ISSUED 870415 AVAIL: PDR 2pp DOCUMENT T YPE: CLOUT FPAC: 8704220130*

TASK. DDID. DIN: 370415-01 DPN: DRN:

DOCKET NO: 03000394 03001649 030145'7 FICHE- 40c2O 116 40620 l'4 5 - R I DS : IEO7D 8704220130 01 Forwards Safety Insp Repts 30-02649/S7-01,30-00394/87-01, 30-14577/87-01,30-17931/87-01 & 70-3044/87-01 on 870323-25 &

l, notice of violation Concirn re mgt control.sgs orpressed.6

, _ improvements requested.

FROM;-AXELSON,W.L. Regtan 3 (Post _820201)

L TO: KISER,W.S. Cleveland-Citnic Foundation. Clevelandi OH p ISSUED; 87041S AVAIL: PDR. 2pp. DOCUMENT TYPE: CLOUT 'FPAC: 8704220130*

TASK: ODID: . DIN: 870415-01 DFN: DRN:

DOCKET NO: 03000394 03017931 07003044 FICHE: -40620 116 40620=145 RIDS: IEO7D'

!~

.._. . ._m.__. _ _._.~_..___ _ _ _. _ . . - _ _ _ _ . _ . . . _ . _ . . - _ . _ _ . . _ . . - . .

'l 1

8/20/_92 PAGE 16- l U. G. NUCLEAR REGULATORY COMMIS510N DCS PARTIAL RECORD FORMAT REPORT 8704220130 JUN Forwards Safety Insp Repts 30-02649/07-01,30-00394/87-01, 30-14577/87-01,30-17931/87-01 0 70-3044/87-01 on-870323-25 &

notice of violation. Concern te mgt control sys expressed &

improvements requested.

FROM: AXELSON.W L. Region 3 (Post 820201)

TO: KISER,W.S. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 870415 AVAIL; PDR 2pp. DOCUMENT TYPE: CLOUT- FPAC: 9207080132A TASK: ODID' DIN- 870415-01 DPN: DRN:

DOCKET NO. 03000394 03002649 03014577 FICHE; 62262 103 62262 137 RIDS: IEO7D B704220130 XD F.rwards~ Safety Insp Repts 30-02649/87-01,30-00394/87-01, 30-14b77/87-01 30-17931/07-01 L-70-3044/87-01 on 870323-25 L notice of violation. Concern re mgt control sys- expressed &

improvements requested FROM: AXELSON,W L. Region 3 (Post 820201)

TO: KISER,W S. Cleveland Clinic Foundatioro Cleveland, OH ISSUED; 870415 AVAIL: PDR 2pp. DOCUMENT TYPE: CL OUT FPAC: 9207080132A ,

T ASK: ODID: DIN- 870415-0) DP N: DRN:

.DOOKFT NO: 03000394 03017931 07003044 FICHE 62262 103 62262 157 RIDS: IEO7D-8704220130 XC Forwards Safety Insp Espts 30-00649/87-01,30-00391/87-01, 30- 14 D7 7 / 87-01, 30- 17 7 31.' 8 7-01 0 ?O-3C44/87-01 on 870323-23 &

notice of vio'ation Concern re mgt control sgs eapressed &

1Grovement5 requested.

FROM. A X ELE',N. W. L . Regton 3 (Post 820201)

TO. KISER,W S- Cleveland C 1 1 n t '. Foundation. Cleveland, OH ISSUED: 870415 AVAIL: PDR 2pp DOCUMENT TYPE: CLOUT FPAC: 9207080132A TASK: ODID. DIN- 870415-01 DPN DRN:

DOCKET NO 03000394 FICHE 62262 103 62262 137 R IDS: IEO7D 8704220146 Notice of eloi.ation from insp on 870323-2b.

I FROM: AXELSON,W L Region 3 (Post 820201)

TO:

ISSUED. 870415 AVAIL. PDR- 6pp. DOCUMENT TYPE TINVID FPAC. 8704220130A T ASK: OD I D- 30-02649/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO: 03000394 03OO2t49 03014577 FICHE; 40620 118 40620 123 RIDS:

-8704220146 01 Notice of vialation from in2p cn_ 870323-25.

F ROM :. AXEL. SON,W.L Region J (Post 820201)

TO:

ISSUEDi 870415 AVAILf PDR 6pp. DOCUMENT TYPE: TINVID FPACi 8704220130A TAFK: ODID: 30-14S77/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO: 03000394 03017931 FICHE: 40620 118 40620 123 RIDS:

8/20/92- PAGE 17-U. S. NUCLEAR REGULATORY _ COMMISSION O

_ DCS PARTIAL RECORD. FORMAT REPORT ,

8704220146 O2 Notice of violation from insp on_870323-2S.

FROM: AXELSON,W.L. Region 3 (Post 020201)

TO:

- I SSUED: 870415 AVAIL: PDR 6pp. DOCUMENT TYPE: TINVID FPAC:. 8704220130A T ASK: ODID: 30-17931/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO: -03000394 FICHE: 40620 118 40620 123 RIDS; 8704220146 XA Notice of violation from insp on 870323-25.

FROM; AXELSON,W.L. Region 3 (Post 820201)

TO:

ISOUED, 870415 AVAIL. PDR 6pp. DOCUMENT TYPE: TINVID FPAC: 9207080132A TASK' ODID: 30-02649/87-01 DIN; 30-00394/87-01 DPN; DRN:

DOCKET NO. 03000394 03002649 03014577 FICHE: 62262 105 62262 ?10 RIDS:

8704220146 YD Notice of violation ficm insp on 870323-25.

FROM: AXEL 5ON,W L. Region 3 (Post 820201)

TO:

ISSUED: 970415 AVAIL POR 6pp DOCUMENT TYPE: TINVID FPAC: 9207080132A TASK: ODID: 30-14577/97-01 DIN 30-00394/87-01 DPN: DRN:

DOCKET NO. 03000394 03017931 FICHE. 62262 105- 62262' 110 RIDS

8704220146 XC Notice of violation frem insp on 870323-25.

! - FROM:- AXELSON,W.L. Region 3-(Post 820201)

T O ;-

~ I SSUED: 870415 AVAIL. PDR 6pp. DOCUMENT TYPE: TINVID FPAC; 9207080132A-TASK: ODID: 30-17931/87-01 DIN: 30-00394/87 DPN: DRN:

DOCKET NO, 23000394- FICHE, 62262.103 -42262-110 RIDS: -

'5704220158 Insp Rep *c 30-02649/S7-01130-00394/87-01,30-14577/87-01,-

30-17931/07-01 L 70"3044/87-01 on-870323-25. Violations n o_t e d ; f a i l u ise to conduct-sem1 annual audits, conduct monthly surveys, maintain records L post caution signs.

FROM: LYNCH-J.L. , Region-3 (Fort 820201) i TO: _ _

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE: TIINSP FPAC: 8704220130B TASK: ODID: 30-02649/G7-01 DIN._30-00394/87-01 DPNi 'DRN:

-DOCKET NO: 03000394 03002649 03014577 FICHE: 40620 124 40620 135 RIDS:

~ --,m- , .

O/20/92 PAGE. 10 U. 5, NUCLEAR REGULATORY COMMISSION-DCS PARTIAL RECORD FORMAT REPORT 8704220138 01 Insp Repts 30-02649/87-01,30-00394/87-01,30-14577/07-01, i 30-17931/87-01 & 70-3044/87-01 on 870320-25 Violations noted: failure to conduct semiannual audits, conduct monthly surveys, maintain records & post caution signs-FROM: LYNCH,J1 L. Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE. TIINSP FPAC: 8704220130D TASK: OD I D: 30-14577/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO: 03000394 03017931 07003044 FICHE: 40620 124 40620 13S RIDS:

B704220138 02 Insp Rep t s 30-02649/87-01,30-00394/87-01, 30-14577/87-01, 30-17931/87-01 & 70-3044/87-01 on 870323-25. Violations noted. failure to. conduct semiannual audits, conduct monthly surveys, maintain records L post caution signs FROM: LYNCH,J.L. Region-3 (oost 820201)

TO:

ISSUED: 870415 AVAIL. PDR 12pp. DOCUMENT TYPE: TIINSP FPAC: 8704220130B TASK: OD I D: 30-17931/87-01' DIN- 30-00394/87-01 DPN: DRN:

DOCKET NO; 03000394 FICHE = 40620 124 40620 135 RIDS:

8704220158 03 Insp Repts 30-02649/87-01,30-00394/S7-01,30-14S77/87-01, 17931/87-01 0 70-3044/67-01 on 670323-25, Violations noted:-failure to conduct semiannual audits, conduct monthly surveys, maintain records & post caution signs.

FROM: LYNCH,J L, Region 3 (Post S20201)

TO:

I SSUED : 870415 AVAIL PDR 12pp DOCUMENT TYPE: TIINSP FPAC: 8704220130B TASK: ODID: 70-3044/97-01 DIN 70-00394/87-01 DPN DRN.

DOCKET NO 03000394 FICHE-- 40620 124 40620 135 RIDS:

T 8704220138 XA Insp Repts 30-02649/87-01,30-00394/87-01,30-14S77/87-01.

30-17931/87-01 & 70-3044/87-01 on 870323-25 Violations noted: failure to conduct semiannual audits. conduct monthly surveys, maintain records O post caution signs.

FROM: LYNCH,J.L Region.3 (Post 520201)

TO:

ISSUED. D70415 AVAIL PDR 12pp DOCUMENT TYPE- 1]INSP FPAC: 9207080132A TASK: ODID- 30-02649/87-01 DIN; 30-00394/87-01 DPN: DRN:

-DOCKET NO: 03000394 03002649 03014577 FICHE- 62262 ill 62262 -122 RIDS:

8704220158 XD Insp Repts 30-02649/87-01,30-00394/87-01,30-14577/87-01, 30-17931/87-01 & 70-3044/67-01 on 870323-25. Violations noted: failure tc conduct semiannual audits, conduct monthly' surveys, maintain records L post caution signs =

FROM: LYNCH,J L. Region-3 (Post 820201)

TO; J ISSUED: 870415 AVAIL: PDR 12pp. . DOCUMENT TYPE: TIINSP FPAC: 9207080132A:

TASK: ODID: 30-14577/87-01 DIN: 30-00394/87-01'-DPN: DRN:

DOCKET NO: 03000394 03017931 07003044 FICHE: 62262 111 62262:122 RIDS:

..- . . . - - . . - - . . . -. - - . -.-.- .. . ~ . - - . . - - . - - . . - .

18/20/92 PAGE- 19' O. S, NUCLEAR'REGULAT_ORY COMMISSION

- DCS P ARTI AL RECORD FORMAT REPORT G704220158 XC Insp Repts 30-02649/07-01,30-00394/67-01,30-14677/07-01, c30-17921/87-01-& 70-3044/87-01 on 870323-25, Violations noted; failure to conduct seciannual audits, conduct monthly surveys. maintain records & post caution signs.

FROM: LYNCH,J.L. Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE: T11NSP FPAC: 9207080132A' TASK: ODID. 30-17931/87-01 DIN: 30-00394/8/-01 DPN DRN:

DOCKET NO: 03000394 FICHE- 62262 til 62262 122 RIDS:

8704220158 XD Insp Repts 30-OE649/87-01,30-OO394/07-01,30-14577/87-01, -

30-17931/07-01 & 70-3044/87-01 on 870323-25. Violations noted:failute to conduct s e n.i ann u a l audits. conduct monthly surveys. maintain records L post caution signs.

FROM: LYNCH,J.L. Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL, PDR 12pp- DOCUMENT TYPE: T11NSP FPAC: 9207080132A T ASK: ODID 70-?O44/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO. 03000394 FICHE- 62262 111 62262 122 RIDS:

8704290199 Forwards Insp dept 90-00394/86-01 on 861120-870210 ?. notice of violation & proposed impeittion of civil penalty in amount of $2, BOO Enforcement conference held on 870304 Notes breakdown of mgt control o4 tadiation therapy program.

FROM: DAVIS.A.B= Regior 3 (Post 820201)

TO: KISER,W,S. Cleveland Clinic Foundation, Cleveland, OH ISSUED; 870415 AVAIL PDR 4pp DOCUMENT TYPE. CLOUT FPAC. 8704290199*

TASK: ODID EA-07-042 DIN- 870415 DP N - DRN:

DOCKET NO: 03000394 FICHE 40732 025 40732 097 RIDS: 1E14D 8704290199 XA Forwards Intp Rtpt 30-00374/86-01 on 861120-870210 S notice of violation L proposed imposition o r civil penalty in amount of 12, BOO,Enfo* cement conference held on 870304 Notes breakdown of mgt control of rediation therapy program FROM: DAVIS,A D. Region 3 (Post B20201)

TO: KISER,W S. Cleseland clinic Foundation, Cleveland,-OH ISSUED: 870415 AVAIL: PDR 3p p - DOCUMENT TYPE- CLOUT FPAC: 9203060423A

- T ASK: ODID: EA-87-042 DIN: 870415 DPN: DRN:

DOCKET ND' 03000394 FICHE. 60899 024 60899 028 RIDSM

-8704290203 Notice of slalation F. proposed impositton of civil penalty

-in amount of-52,500.

FROM: DAVIS,A.B. Region 3 (Post C20201)

TO:

ISSUED; G70415 AVAIL: PDR 2pp. DOCUMENT TYPE. TINVID FFAC. 8704290199A-TASK: ODID. EA-87-042 DIN: NVID-870415 DPN: DRN:

DOCKET NO: 03000394 FICHE. 40732 029 40732 030 RIDS:

_________.._____2_ _ _ _ _ - _ _ _ _ _ _ _ _ _

B/20/92 PAGE' 20 U. S. NUCLEAR REGULATORY-COMMISSION DCS PARTIAL RECORD FORMAT REPORT r LB704290203.XA Notice of vio]ation-L proposed imposition-of civil penalty in amount of $2.500.

FROM: DAVIS >A.D. Region 3 (Post 820201)

TO:

ISSUED: 87041b AVAIL. PDR 2pp. DOCUMENT-TYPE: -TINVID FPAC- 9203060423A TASK: ODID: EA-87-042 DIN: NVID-870415 DPN; DRN: 2 DOCKET NO: 03000394 FICHE: 60099 027 60899 028 RIDS:

8705260306 Responds to 870415 notice of violation & proposed imposition of civil penalty from insp on 661120-870210. Corrective actions: technical staff _ meeting held on 861205~to advise of 24 h notification 6 other NRC requirements..

FROM: KISER,W.S. Cleveland Clinic Foundation, Cleveland, OH 2

TO: NRC - No De tailed Affiliation Given ISSUED: 870514 AVAIL: PDR Spp. DOCUMENT TYPE: CLINC FPAC: 8705260306

. TASK. OD I D. EA-87-042 DIN: 870514 DPN: -DRN:

DOCKET NO: 03000394 FICHE: 41038 300 41038 309 RIDS: IE14D 9705260306 XA Responds to 870415 notice of violation _& proposed imposition of civil-penalty from insp on 66112D-870210, Corrective actions technical staff meeting held on 861205 t ti advise of 24 h notification & other NRC requirements.

FROM: KISER.W.S Cleveland Clinic Foundataon. Cleveland, OH-TO: NRC - No Dete:1ed Affiliation Given ISSUED: 870514 AVAIL. PLR 5p p. DOCUMENT TV'E: CLINC FPAC. 9203060423A TASK. DDID EA-87-042 DIN. 870514 DPN: DRN;

' DOCKET NO- 03000394 F I C HE : 60399 029 60899 OSS RIDS:

8706240090 Ack recexpt of E70514 payment for civil penalty in .smount of

$2,500 Cortective actions wt11 ble examined during future insps:

FROM: LIEBERMAN J. Ofc of Enforcement (Post 870413)

TO: KISER W.S. Cleveland Clintc Foundation, Cleveland, OH ISSUED. 870$22 AVAIL: PDR 2pp. DOCUMENT . TY P E: CLOUT _FPAC: 8706240090 TASK: ODID: EA-87-042 '

DIN; 870622 DPN; DRN:

DOCKET NO: '03000394 F!CHE: 41436 136- 41438 .137 R IDS: IE14D G706240090 XA Ack-receipt of-870514. payment for civ11-penalty ir amount of

$2,500.Cr.rective actions will be t-anminec during future-insps.

FROM: LIESEPMAN,J Of c .of Enforccment (Post 870413)

.TO :- KISER,W.S. l Cleveland-Clinic Foundation, Cleveland, OH L ISSUED: 870622 AVAIL: .PDR 4p p. DOCUMENT TYPE: CLOUT FPAC: 9207080132A TASh: ODID; EA-87-042 DIN: -870622 DPN: DRN:

L DOCKET NO: 03000394 FICHE: 62262 138 -62262 141' RIDS: IE14D D _ . _ . _ _ _ . _ _ . . _ . _ _ . _

G/20/92~ PAGE 21 U. $. NUCLEAR REGULATORY COMMISSION- ,

DCS PARTIAL RECORD FORMAT REPORT 8001110371 Volds Cleveland Clinic Foundation application under Control Number 82925 due to combination w/ application under Control Number 83519 FROM: MALLETT,B. Region 3 (Post 820201)

TO: License Fee Management Branch ISSUED: 870717 AVAIL-- PDR- 1p, DOCUMENT TYPE: CMMEMO FPAC; 8801110371*-

TASK: ODID. 82925 DIN: 870717-01 DPN: DRN:

DOCKET NO; 03000394 FICHE: 43990 187 43990 194 RIDS: ML3OD

-8801110371 01 Vosos Cleveland Clinic Foundation app 1tcation under Control Number 82925 due to combination w/ application under Control -

Number 83518.

FROM: MALLETT.B. Regton-3 (Post 320201)

TO: License Fee Management Branch ISSUED: 870717 AVAIL' PDR 1p. DOCUMENT TYPE: CMMEMO FPAC: 8801110371*

TASK: OD I D: 87518 DIN: G70717-01 DPN: DRN:

DOCKET IKJ- 03000394 FICHE' 43990 187 43990 194 RIDS: ML3OD.

0801290204 Requests that Item 9 to license, assigning one source for use

in AECL Theratron 780 teletherapy unit L another source for replacement be included w/870115 application for amend to license,per 370728 tolton Returd of 870728 telcon e n t 1.

FROM: ARON.S J Cleveland Clinic Foundation. Cleveland, OH

- TO: WHISTON,F. Region 3 (Pott R20201)

ISSUED: 870729 AVAIL- PDR 2pp DOCUMENT TYPE- CLINC FPAC: 88012801664 TASK: ODID- 82816 DIN: 870728 DPN: ~

DRN-DOCKET NO- 03000394- FICHE: 44167 G77 4416~? 103 RIDS:

8S01280166- Amend 20 to License 34-00465-02 for C14veland Clinic Foundation. changing Item 9 A that authorizes one source for use in taletherapy un:t h another for *eplacement purposes 6-Condition 12 that names supervisors for licensed matl use.

'FROM: WHISTON,P.J. Region 3 (Pott 820201)

TO:

ISSUED: G70810 AVAIL PDR 1p, DOCUMENT TYPE- TLLMBL FPAC: 8801280166*-

TASK: ODI D . DIN: 34-00466-02 DPN: A20 DRN:

DOCKET NO: 03000394 FICHE: 44167 076 44167 103 RIDS: -ML30D 9207080346 Discusses assast to f re p by RIII-01 re Cleveland Cl2nic Foundation conterning a l-l e g e d . m 1 5 a d m i n i s t r a t i o n -

FROM; HIND, J A. _ Region 3 (Post 820201)

TO; WEILfC.H. Region 3 (Post G20201)

ISSUED: _871110 AVAIL: PDR 16pp DOCUMENT TYPE- CMMEMO FPAC: 9207080281A TASK; ODID: DIN' 871110-01 DPN: DR N :-

DOCKET NC. 03000394 FICHE: 62273 227 62273 243 RIDS;

~!

.- . . . . . - . ~ . - - . . - - - - - - - _ . - - . - _ - - - , - . ~-

8/20/92 PAGE 22 U. S; _ NUCLEAR REGULATORY-COMMISSION.

DCS PARTIAL RECORD FORMAT REPORT 6811230370 Submitt addl Info, including partially' deleted radiation safety committee repts re two cases of possible misadministrations of Co-60 teletherapy. Info submitted per 880330 telcon request.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH

.TO: WIEDEMAN,D. Region 3 (Post 820201)

ISSUED- 880418 AVAIL: PDR 43pp. DOCUMENT TYPE: CLINC FPAC: 8811230354AA-TASK: ODID. DIN: 880418 DPN: -DRN:

DOCKET NO: 03000394 FICHE: 47652 173 47652 224 RIDS:

8811230354 Forwards insp Rept 30-00394/06-01 on 890811.Two cases of possible misadministrations re use of Co-60 teletherapy machine evaluated,per 860418 ltr.NRC concerns pertaining to

. potential violations in Case 2 under review.

FROM: NORELIUS,C.E. Region 3 (Post 820201)

TO: KISER,W.S. Cloveland Clinic Foundation, Cleveland, OH ISSUED- 881115 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 88112303S4*

. TASK: ODI D. EA-66-273 DIN: 881115 DPN: DRN:

DOCKET NO 03000394 F I C HE : 476S2 162 47652 224 - RIDS: IES4D

'8811230361 Insp Rept 30-00394/88-01 on 880811 One of two allegetions unresolved Major areot inspected allegations re possible teletherapy misadministrations at vuidentified medical institutien & Cleveland Clinic Foundation =

FROM: BURGIN,R.E. Region 3 (Post 820201)

TO:

I SSUED: 881115 AVAIL- PDR 9pp DOC UMENT TYPE. TIINSP FPAC: : 8811'230354 A TASK: ODID DIN. 30-00394/88-01 DPN: DRN:

l ~ DOCKET ND- 03000394 F ICHE 47e52 164 47652 224 RIDS-9 9006050132 Matls licenizag pectage for Amend 22 to License 34-00466-02 for Clev+1and Clinic Foundation. Control--363570 FROM: PELAE.P.J Region 3 (Post G20201)

TO:

ISSUED: .881212 AVAIL. PDR 21pp. DOCUMENT TYPE: TLLMBL FPAC: 9006050132 TASK: ODID 383570 ~ DIN 34-00466-02 DPN: A22 DRN:

DOCKET ~NOL 03000394 FICHE: 33979 100 03479 119 RIDS: ML30D 9003140046 Matls licensing package - f or Amend 23 to License 34-00466-02

.for Cleveland Clinic Foundataon, Rad:stion Safety Of c.

Control: 333790 FROM: PELKE,P J. Regton 3 (Post 820201)

TO:

ISSUED: '890112 AVAIL: PDR Spp. DOCUMENT TYPE: TLLMBL FPAC: 9003140046

-TASKi ODID: 383790 DIN: 34-00466-02 DPN: A23 DRN:

DOCKET NO. 03000394 FICHE: 52958 141 .52958 145. RIDS: .ML30D .

i L

'l

~ . _ . _ _ . _ -. ..._._. ,, _ ... _ _ __ _ .._.. - . __ . - . _ _ _

8/20/92 PAGE. 23

' U. S. NUCLEAR REGULATORY COMMISSION DCS PARTI AL RECORD FORMAT ' REPORT L9206180377- -Partially deleted Itr ve Cleveland Clinic Foundation' furnishing incorrect-info concerning teletherapy misadministration at clinic during Nov 1986. ,

_ FROM: WEIL,C.H. Region ? (Post 820201)

TO: Cleveland Clinic Foundation, Cleveland, OH-ISSUED: 890130 AVAIL. PDR 1p- DOCUMENT TYPE: CLOUT FPAC: 9206180321A-TASK: ODID: DIN: 890130 DPN: DRN:

DOCKET NO: O3000394 FICHE: 62105 077 62105 077 RIDS:

8903030494 Discusses Insp 30-00394/88-01 on 880811 & forwards notice of violation. Advises that NRC carefully reviewed two cases discussed in licensee 880418 Itr.In Case 1, dose appears to have been delivered from Co-60 sources as was prescribed. '

FROM: DAVIS,A.D. Regton 3 (Post 820201) .

TO: KISER.W.S. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 890223 AVAIL: PDR 4pp. DOCUMENT TYPE: CLOUT FPAC: 8903030494*-

TASK- DDID: EA-88-273 DIN. 890223 DPN; DRN:

DOCKET NO: 03000394 FICHE: 48693 265 48693 330 RIDS: IE14D 8903030494 XA Discusses Inst 30-00394/38-01 on 880811 L Forwards notice of violation. Advises that NRC ccTefully reviewed two casec discussed i n licensee 850433 3tT. In Case 1> dose appeers to have been delavered from Co-60 sources as was piescribed.

FROM: DAVIS,A.B. Regacn 3 (Post 820201)

TO. KISER W S. Cleveland Clinic Foundation. Cleveland, OH-ISSUED: 690223 AVAIL' PDR 4p p. DOCUMENT TYPE CLOUT FPAC: 9203060423A

, TASK: DDID- EA-89-273 DIN: 890223 DPN: DRN:

DOCKET NO: 03000394 FICHE: 60899 122 60399 126 RIDL:

8903030498 Notice of violatton fram insp on 890811. Violation noted; misadministration of radlopharm occurred in Aug 1995 L

.ticensee did not rept event untti 880408 FROM: DAVIS,A.B: Region 3 (Pott BRODO1)

TO:

755VED- 890223 AVAIL: PDR. Ip DOCUMENT TYPE: TINVID FPAC: 8903030494A-TASK: ODID. EA-85-273 DIN: 30-00394/86-01 DPN: DRN:

DOCKET NO, 03000394 FICHE: 45693~269 48693 330' RIDS:

8903030498 XA Notice of violation from insp on 830911'. Violation noted:

misadministration of radiophar.r occurred in Aug 1995 &

licensee dad not rept event until 860406 FRCMf DAVI5.A.B. Region 3 '(Post 820201)

L - TO:

ISSUED: 890223 AVAIL: PDR -1 p . DOCUMENT TYPE: TINVID FPAC: 9203060423A-TASK: ODID- EA-88-273 DIN- 30-00394/89-01 DPN: DRN:

DOCKET NO: 03000394 FICHE: 60899 126 60899 126 RIDS:

l 1

- ^ - -- c Aw .-4 --s-

. o -.y .y- p p.p... --p--,_ 9 q .,,,,rm.7.,,.,.,w,mwa -

,e.,-sw, r-av 9w w--w

8/20/92 ~PAGE 24- '

Us SL NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9906290379 Requests clarlfication of 24 h rule per 10CFR3S.33(a) for misadministrations,per 890309 telcon re NRC 890223 notice of violation.

FROM: ARON,S.J. Cleveland Clinic-Foundation, Cleveland, OH TO: WIEDEMAN,D. Region 3 (Post 820201)

ISSUED: 890315 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8906290376A TASK: OD 1 D; DIN: 890315 DPN: DRN:

DOCKET NO-. 03000394 FICHE: 50377 295 50377 295 RIOS:

6406290379 XA Requesto clarification of 24 h rule per 10CFR35.33(a) f or.

misadministrations,per.890309 to1 con re NRC 890223 notice of violation.

FROM: ARON.S.J Cleveland Clinic Foundation, Cleveland, OH TO: WIEDEMANsD. Region 3 (Post 820201)

ISSUED: 890315 AVAIL PDR 1p. DOCUMENT TYPE: CLINC FPAC: 92O3060423A T.* S K : ODID DIN: 890315 DPN; DRN:

DOCKET NO: 03000394 FICHE: 60899 121 60099 121 RIDS:

8906290376 Clarifles NRC requ17ementt For T epor t ing mi s adminis trations,

. per 100FR35 33(a) NRC views therapeutic m15adm2nistrations as serious matter L will issue notice of violation if reporting not in accordence w/ regulations.

FROM: NORELIUS,C.E. Region'3 (Post 820201)

TO: ARON 5.J. Cleveland Clinic Foundation, Cleveland, OH ISSUED. 690622 AVAIL- PDR Opp DOCUMENT TYPE: CLOUT FPAC: -3906290376+

TASK: UDID EA-SS-273 DIN. S?O622 DPN; DRN:

DOCKET NO. 03000394 FICHE 50377 293 50377 295 RIDS: IEO7DL G906290376 XA Clariftes NPC requirements for reporting misadministrations, per 10CFR35 33(a).NRC views therapeutic mtsadministrations as serious matter 6 will issue notice of violation if reporting not in accordance w/ regulations.

FROM: NORELIUS.C E Region 3 (Pont 820201)

TO: ARON,S J. Cleveland C l_i n i c Foundation,-Cleveland, OH ISSUED: 890622 AVAIL PDR 2pp. DOCUMENT 1 T_YP E : CLOUT. FPAC: '9203060423A l . TASK: ODI D: EA-88-273 DIN: 890622 DPN: DRN:

DOCKET NO 03000394 FICHE: 60899 119 60899 121 RIDS:

l 9006060001 Matls licensing package for Amend 25 to License 34-00466-02 for Cleveland Clinic Foundation. Con tr ol: 337976.

l l FROM: PELKE<P.J. Region 3 (Post 300201)

TO:

ISSUED! 891005 AVAIL PDR 4pp. DOCUMENT TYPE: .TLLMBL'FPAC: :9006060001

-T ASK: ODID: 387976 DIN: 34-00466-02 DPN: A25 DRN:

L DOCKET NO; 03000394 FICHE: 54002 203- 34002 206 RIDS; 'ML30D l

l ..

._-.- -.- _ -.- - - - . - . _ _ . - _ - - . - _ - - - - ~ ~ . . . . - . - . .

) O/DO/92 PAGE 25 1 U. 5, NUCLEAR REGULAfDRY COMMISSION DCU PARTIAL Rt?COND FORMAT REPORT ,

a i

900430003o Confirms 900416 telcon te arrangements for enforcement

, conference on 900b02 in Olen Ellyn,IL to discuss failure to

, rept therapeutic mt$ administration on timely basis, cotrective actions & NRC enforcement options Notice enc 1.

FROM- NORFLIUS,C.E. Region 3 (Fost 820201)

TO: LEES,J E. Cleveland Clinic Foundation, Cleveland, OH I SSUED: 900419 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9004300036 TASK. UDI D- EA-90-074 DIN: 900414 DPN: .

DRN: !

, DOCKET NO: 03000394 FICHE: 53636 000 S3636 081 RIDS: !EO7D +

W 9005000120 For ward s Gaiety 1nep Rept5 30-02649/90-01,30-00394/90-01, 30-14577/90-01 h 70-3044/90-01 on 900307-0405 Violatione, &

( repeat concern for lack of cooperation between therapy dept b radiation safety oft identified. <

FROM: NDREL1US,C.E, Region 3 (Post O20201)

TO LOOP,E Carveland Clinic Foundation, Cleveland, OH i I SSUE D: 900427 AVAIL PDR 2pp DOCUMENT T'YPU: CLOUT FPAC: 9005080120*

TASK' ODI D. EA-90-074 DIN 900427 DPN: DRN:

DOCKET NO 03002649 03000394 03014577 FICHE- S3769 299 b3769 351 R I DS: IEO7D 900 sot 3012G Sofety insp Rspt5 30-02649/90-01,30-00394/90-01, 30-14577/'iO--01 f.- 70-3044/Y0-01 on "00307-09,14-16 & 0313 7<

19-0400 Major areas inspetted re, tem of iteensed programs, organ a z o t t on,1nt er nal aud i t program & notifications, & repts.

FROM- MATSON,E R Region 3 (Post 820201)

TO' '

ISSUED 900427 AVAIL PDR bi p p. DOCUMENT 1YPE TIINSP FPAC- 900SOG0120A TASK: ODID- 30-00394/90-01 din: 30-02649/90-01 DPN: DRN; DOCRET NO. 03002649 03000394 03014977 FICHE; S3769 301 53769 351 RIDS:

N 9005290279 Sefety Insr Rept5 30-02649/90-02,30-00394/90-02 L 30-14577/90-02 on 900307-09,14-t6 L 0419-20.V1c)ations n ce t e d . P 5 j or ateas inspetted ellegations received on B90829 re licensee FROM; MATGDN,E R. Region 3 (?ost 820201) ,

TO:

' ISSUED 900$18 AVAIL PDR wopp DOCUMENT 1/PE: TIINSP FPAC. 900529027DD TASK. ODI D' 30-0264w/90-02 DIN: 30-00394/90-02 DPN. DRN:

DOCKET ND~ 03002649 03000394 03014b77 FICHE- S3947 261 53947 300 RIDS: '

900329027D Forward 5 Safety Inap ReptS 30-02649/90-02,30-00394/40-02 &

30-14577/90-02 on 900307 0420 & notice of violation.

FROM 40R EL I US, C E- Region 3 (Post G20201)

TO, 4. COP , F Cleveland Clinic Foundation, Cleveland, OH

, ISSUED: 900922 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 900S29027S*

T ASK: OD I D: DIN: 900522 DPN: DRN:

. DOCKET NO: 03002649 03000394 03014577 FICHE: 53947 2S7 53947 300 RIDS: IEO7D ,

1 4

,..~.u . ,m4_,,_.,,,,,N-r,e, ,,,..,_,.,,..-.,,,me,m-c,, y.m.,. -r.,_, _

m %_w .n., y,_w...,mm m, ,,, ,w,,_.y.3-m.~,wp,.. cmp,.,,,. .,e

_. ___ _..______.___._..___.-...__-____m.____.____, _

O/20/92 PAGE 26 i U 5, NUCLEAR REOULA10RY COMMISSION l l

DCS PARTIAL RECORD FORMAT REPORT !

l I

4 9006130469 Forwards Enforcement Conference Repts 30-02649/70-03 &

30-00374/V0-03 on 900502. !

FROM; NORELIUS,C.E. Region 3 (Post 820201)

TO: LOOP.F. Cleveland Clinte Foundation, Cleveland, OH ;

ISSUED: 900523 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9006130469* '

TASK: ODID: EA-90-074 DIN: 900523 DPN: DRN:

DOCKET NO: 03002649 03000394 FICHE. 54167 357 54167 360 RIDS: IE46D ,

9006130474 Enforcement Conference Repts 30-02649/90-03 6 30-00394/90-03 on 900502. Major errar discotted.NRC concern te apparent lack of cooperation b communications between Cleveland Clinic Radiation Therapy Dept b Radiation-Safety Oft. i FROM: MATSON,E.R Region 3 (Post 820201)

TO: <

ISSUED: 900523 AVAIL: PDR 3p p = DOCUMENT TYPE: T!!NSP FPAC: 9006130469A TASK: ODID: 30-00394/90-03 DIN: 30-02649/90-03 DPN: EC DRN:

DOCKET NO 03002649 03000394 FICHE: 54167 350 54167 360 RIDS: l 9006250004 EN-90-061.on 900621, notice of proposed imposition of civil penalty in amount of 46 G75 will be issued to licensee, Action based on violation involving fatture to rept therapy >

misadministration within requited 24-hr time period.

FRDM: JOHANSEN,J Ofc of Enforcement (Post 870413)

TO:

ISSUED; 900618 AVAIL: PDR 1p DOCUMENT TYPE: TIEN FPAC: 9006250004 TASK: OD 1 D. EA-90-074 DIN. EN-90-061 DPN: DRN:

DOCKET NO: 03000344 FICHE: 542S3 322 04253 322 RIDS: JE33F 9006270287 Fovwards Insp Repts 30-00394/90-01 t 30-02649/90-01 on 900307-09 0 14-16 L notice o f- v i o l e., t l a n & proposed i rf4p o s i t a o n o f civil pcnalty in amount of $6,875.

FROM: DAVIS.A.D. Regton 3 (Post 820201)

TO: LOOP,E Cleveland Clinic Foundation, Cleveland. CH ISSUED. 900621 AVAIL PDR Spp. DOCUMENT TYPE: CLOUT FPAC: 9006270287*

' TASK: OD I D. EA-90-074. DIN. 900621 DPN: DRN:

DOCKET NO. 03000394.03002649 FICHE: $43421123- S4342.181 R IDS: IEO7D 1 9006270257 AA For ward s Insp Repts 30-00394/90-01 b 30-02649/90-01 on 900307-09 L 14-16 L notate-of- violation b proposed i rfip o s i t 2 o n o f civil penalty in amount of $6,875.

FROMi DAVIS,ALB. Region _3 (Post-820201)

~

TO: LOOP,F _ Cleveland, Clinic Foundatton, Cleveland,ROH I SSUED: 900621 AVAIL- PDR 4pp. DOCUMENT TYPE: CLOUT FPAC: 9203060423A.

TASK: ODID: EA-90-074 DIN: 900621. DPN: DRN:

DOCKET NO: 03000394 03002649 FICHE: 60899.102 60G99 110-RIDS:

- ;- - , ,-.,. - ..-- -.---.._.a.a.,.-,, , - . . . . - . . . - - . - - . - . - . . - . . - .

b/20/92 PAGE 27 U. 5. NUCLLAR RFGULATORY COMMISSION DCS PARTIAL NFCORD FORMA 1 REPORT 9006270294 Nottce of vialation 5 proposad imposition of c1vil penalty from insp on 900307-09 ?, 14-16. V i o l a t t atis noted failure to notify NRC of therapy misadministration within required 24 h 6 survey instrument not calibt from 19G8-1990 FROM: DAV15,A D Region 3 (Pott 620201)

TO:

ISGUED 900621 AVAIL- PDR 3pp. DOCUMENT TYPE: TINVID FPAC: 9006270207A TASM. ODID: EA-90-074 DIN NVID-YOO621 DPN: DRN:

DOCKET NO- 03000394 03002649 F I CHE : S4342 128 S4342 101 RIDS:

90062'/0294 >A Notice of violatten t. proposed imposition of civil penalty from insp on 900307-09 L 14-16. Violations noted failure to notify NRC of therapy misadministration within required 24 h b s,vrvey i n a, t t u m e n t. not talibi from 1900-1990 FROM: DAVIS.A B Reg 1on 3 (Port U20201)

TO:

ISSUED: 900621 AVAIL PDR 3pp. DOCUMENT TYPE TINVID FPAC: 9203060423A TASK DDID Etr90-074 DIN NVID-900621 DPN: DRN.

DOCKET t10 03000394 03302649 F I C HE . 6009'i 106 60899 118 RIDS.

4103190354 C u b m i t e, action p1an for GA prt; ram of dept of radiatton therapy approved by of t of quality m;t Entire GA program teviewad s a m t a n n u t:1 1 y TROM: KEvC T F Cle. eland Clinic Foundetton4 Clevesend, OH TO MAtLETT.D Fs Pegion 3 (Post 020201)

IGLUED 'G r2: AVAIL I- Dis 13pp OCCU'1EN7 7(PE CLINC IPAC. 9103190263D TASK- ODID DIN 900620-01 DPN: DRN; DOCKET ND 03000394 FICHE- 57090 080 L7090 092 RIDS:

9 06100341 Forwards begion III trsr rept in r- ansa to 690105 request for inic c e allegation R I T 1 -- 6 9 - A- ON I .

FROM FLw , D E Region 3 (Pcst f320201 )

TO- PAULIV,E T 9egion 3 (Pott 132020 )

ISSUED '; O h 2 5 A',% 1 L ' PPR 1p DOCUMENT TYFE CMMEMD rFAC 92061GO321A TASK: ODID DIN: 9006Z't DPN: DRN.

DOCVET NO- 03002649 02000394 03014577 FICHE 62105 032 62105 072 R IDS:

0010110093 MatIs 11trosang patiage for Amrnd 26 to Lacense 34-00466-02 for Cleveland Clinic Foundation Control- 337401 FROM. HUETER,L J Region 3 (Post BDD201 )

TO:

ISSUED: 90De26 AVAIL PDR S2pp. DOCUMENT TYPE- TLLMDL FPAC: 9010110093 TASK- DDID 339401 DIN: 34-00466-02 DPN: A26 DRN:

DOCKET ND 03000394 FICHE- Sb378 330 55379 020 RIDS: ML30D

, . - _-- .- . .. _. - . - -. - - - . - . - . . . - - - ~ . - - - - . . . - - -

G/20/92 PAGE 20

.V, S. NUCLEAR REOULATORY COMMISSION DC5 PARTIAL RECORD FORMAT REPORT 4

9010180142 Matts licensing paciage for corrected Amend 26 to License i 34-00466-02 for Cleveland Clinic Foundation.

1 FROM: HUETER,L.J. Region 3 (Post 820201)

TO: i ISSUED: 900718 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 9010100142 TASK: OD1D. DIN: 34-00466-02 DPN: A26 DRN: 01 l DOCKET NO: 03000394 FICHE: 55474 205 55474 206 RIDS: ML30D t 9007260020 Responds to NRC 900622 notice of stolation te insp of-Licenses 34-00466-01 & 34-00466-02 & forwards payment of i civil penalty.

FROM: LOOP,F.D. Cleveland C2inte Foundation, Cleveland, OH TO: Ofc of Enforcement (rost 070413)

ISSUED: 900719 AVAIL: PDR 4pp. DOCUMENT TYPE: CLINC FPAC: 9007260020 TASK: ODID: EA-90-074 DIN: 900719 DPN: DRN:

--DOCKET NO- 03002649 030003c4 FICHE. 54722 314 54722 317 RIDS: IEO7D 9008170030 Ack receipt o f- 900719 It? forward 2ng payment of civil penalty per.NRC 900621 Itr

'FROM: LIEDERMAN,a Ofc o t' Enforcement (Fost 870413)

TO: LOOP,F. Cleveland Clinte Foundation, Cleveland, CH '

ISSUED, 900609 AVAIL: PDR 1p DOCUMENT TYPE: CLOUT FPAC: 9008170030 TASK: OD I D. EA-90-074 DIN: 900809 DPN: DRN:

DOCKET NO' 03000394 FICHE: S4984 172 S4984 172 RIDS: !E14D-9011190156 Mat 1s licensing p a c t ra g e f or Amend 27 to Lt:ense 34-00466-02 f or C l e ve l and Cl i ni c Fc.un d+ t 2 cin. Cont r ol: 38V799 I

FROM: HUTTER,L J. Region 3 (Post 820DO1)

TO:

I SSUED: 900926 AVAIL PDR 7pp. DOCUMENT TYPE TLLMDL= FP AC: 9021190156

, T ASK: ODID: 389799 D .t N : 34-00466-02 DPN: A27.DRTO DOCKET NO: 03000394 FICHE: SS783 061 55783 067 RIDS: ML30D 9012030080 Forwards addl info re action plan f or GA' pr ogram, p er 90062S

- 1 tr.

FROM: KEYS,T.F, Cleveland Clinic Foundation, Cleveland, OH' TO: MATSON,E.R. Region 3 (Post G20201)

ISSUED: 900928 AVAIL: PDR- 1p. DOCUMENT TYPE: CLINC FPAC: 901203OO70A TASK: ODIDs DIN: 900928- DPN: DRN:

DOCKET NO: 03002649 03000394' FICHE: 'SS989 IS1 .SS989 154 RIDS:

(

-m.i-..., , ,_.m- ,4, , , , . . . , , , ev.-m. - -*, ,-..-m..,, .m m m + %~.,m.ar.m~_--.me

8/20/92 FAGE 29 '

U. S NUCLEAR RLCULATORY COMMISSION DCS PARTIAL RECURD FOHMAT HEPORT

? G34 -

901203OO7e Discusses 900502 enf or c oment conference un' s t a f f to discuss ~ ~

licensee plana to improve apparent c om1iun i c a t i o n s problem A FROM. DAVIS,A.D. Region 3 (Post G20201)

TO: LOOP,F Cleveland Clinic Foundation, Cleveland, OH ISSUED. 901126 AVAIL: PDR 1p DOCUMENT TYPE CLOUT FPAC: 9012030070*

TASK OD1D DIN- 901126 DPN: DRN:

DOCKET NO: 03002649 03000394 FICHE 50989 100 SS989 104 RIDS: IEO7D 9101180246 Mat 1s licensing pa:kage for Amend 20 t ti Licente 34-00466-02 for Cleveland Clinit Foundatioro t e r is i n a t i n g license.

Control 390533 FROM. NULL,K G Region 3 (Post B20201)

TO-ISSUED 901217 AVAIL. PDR lopp. DOCUMENT lYPE. TLLMBL TPAC: 9101180246 TASK- DD I D- 390533 DIN 30-00466-02 DPN: A28 DRN.

DOCKET NO 03000394 F1CHE. StA49 322 36449 331 RIDS: ML30D 910319026R Responds to 701126 Itr T equesting follow-up assessment of effectivenost of impro<ed comN n1(c'1t,s et C l e -s e l a n d Clinic Foundatlon FROM: KEYL 1 F Clevelan* C1tnic Foundaticn, Cleveland, OH TO. DAVIS,A B Region ; iPast 020201)

ISSUED 901210 AVAIL = PEG 3pr DOCUMENT 1YFE CLINC FPAC 9103140263A TASK- OD I D - EA 30-074 DIN: 90121E DF N . DRN-DOCKET t'O 03000394 FICHE $7090 077 57090 079 RIDS.

9106100338 Volded matit ilcensing :tien for license 34--00466-02 for Clevelare .linic Foundation control 3 W210 FROM- *- Region 3 (Pctt 8Z0201)

TO Licente Fee 1:in a g e n.e n t D r a r. c h ISSUED 910122 AVAIL PD7 5pp DDC U'l1:NT T(PE CMMEMD FPAC. 9106100339 T ASK : 0D10 39021S DIN- 910122 DPN: DRN:

DOCKET NO- 03030394 FICHE- 53024 196 S6024 203 RIDS: ML30D 9103190263 Respcods ta c o l'218 1 t. r 1eque; ting Lr1tten suse?tment of effectiveness of meetings designed to improve communicottons between licent,ee & d i r' e c t o r af ofc of quality mgt FROM: GHDBE, J A Peg:on 3 (Poc t B00201)

TO: LOOP,F Cleveland Clinic Foundation, Clev& land, OH ISSUED: 910308 AVAIL PDR 1 p. DOCUMENT TYPE: CLDUT FPAC: 9103190263*

T ASK: ODID- DIN- 910309 DPN: DRN:

DOCKET NO. 03000394 FICHE: 57090 076 57090 092 RIDS: IEO7D mi-- - ---

5

. 'O/92 PAGE 30 U S NUCLEAR REGULATORY COMMISSION DC5 PARTIAL RECORD FORMAT REPORT 9207230267 Informs of 910629 misadministtation of radiopharm Wrong patient given 21.2 mC1 Tc-99m MDP instead of 10.0 mci Tc-99m l Mag-3. Caused by Technologist error. Procedures implemented j for verification of patient identification.

FROM; ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201) i ISSUED: 910702 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 92071SO10BA T ASK: ODI D: DIN: 910702-01 DPN: DRN:

DOCKET NO: 03000394 F ICHE: 62546 067 62546 060 RIDS: ,

9207230267 01 Informs of 910629 misadministration of radiopharm. Wrong patient given 21.2 mci Tc~Y9m MDP instead of 10.0 mC1 Tc-99m ,

Mag-3. Caused by Technologist error. Procedures implemented ,

for verification of patient identification.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH ,

TO: Region 3 (Post 020201)

ISSUED: 910702 AVAIL: PDR 2pp. DOCUMENT 1YPE: CLINC FPAC: 92071SO100A TASK: ODTD: DIN- 910702-01 DPN: DRN:

DOCKET NO. 03000394 FICHE. 62346 067 62346 068 RIDS:

9201310028 Confirms 920121 telton isgreement w/WH Schultr concerning receipient serving as medical consu) tant to NRC to evaluate '

individuel involved in incident described in encl.

FROM: DAVIS,A B Region 3 (Post 020201)

TO: MIRALDI,F.D. Cleveland Clinic Foundation, Cleveland, OH -

ISSUED. 920124 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9201310028 TASK: ODID- DIN: 920124 DPN: DRN:

DOCKET NO 03000394 FICHE 60413 101 60413 102 RIDS: -!EO7D t

l =-

i

PD/2 So -4 6 c/f THIS DOCUMENT WAS PRODUCED BY THi U. S. NUCLEAR REGUL ATORY COMMISS!( ~

NUDOCS OPERATED BY STATISTICA, INC.

UNDER CONTRACT NO. NRC-39-GO-21

'y .

8/20/92 FAGE 1 U S. NUCLEAR REGULATORY COMMIGSION DCS PARTIAL RiiCORD TORMAT REPORT 9207160301 Informs of 801216 misadministration of radiopharm. Patient inadvertantly injected w/ portion of bone Scan dote,namely 7 mC1 of T-99m metidronate,instead of liver scan.No ill effects noted. Adequate study obtained.

FROM: COOK,S.A. Cleveland Clinic Foundation. Cleveland, OH TO: COOPER,J. Region Ill. IE (720101-810228)

ISSUED: 810105 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 920715010GA TASK: ODl D. DIN: 810105 DPN: DRN:

DOCKET NO' 03002649 FICHE: 62546 004 62546 004 RIDS:

9207160327 Inf or ms of 810522 m15 administration of radiopharm. Patient inadvertently injected Tc-99m sulfur colloid.Done scan done i following day b revealed source of pain. Technologist involved admonished to check patient name w/ isotope. '

FROM: COOK,5.A Cleveland Clinic Foundation, Cleveland. OH TO: COOPEh,J Rtgion 3, Oft of the Directcr (810301-820201) ;

ISSUED: 810527 AVAIL PDP 1p. DOCUMENT TYPE: CLINC FPAC: -920715010BA T ASK: OD1D. DIN: 810527 DPN: DRN:

DOCKET NO 03002649 FICHE- 6D546 005 62546 005 RIDS:

6111110778 IE Insp Fandshys A Licensee Ac6 dtd 811028 of License ,

34-00466 -01. I n s p f a tid ing s disposal recordt not properly maintained b leak test records not maintained as prescribed in license FROM: DURGIN,R,E. Region 3. Ofc of the Director (810301-820201)

TO:

ISSUED: 511028 AVAIL. PDR 1p DOCUMENT TYPE = T11FLA TPAC: 8111110778 -

TASK: OD1D DIN- IFLA-811028-01. DPN: DRN:

DOCKET NO. 03002649 FICHE: 10603 078 10603 078 RIDS: IEO7S S31205026* Discusten IE .t n s p of Lacentes 34-00466-01,34-00466-02, 34-OD46v 03 h 34-00466-04 on 03:117 L forwards notice of vioiction.

FROM: SH EN I A.4SK I . D. J. Region 3 (Post G20201) '

'TO: PAVLICEK,W C3eveland Clinic Foundation, Cleveland, OH ISSUED.. 831124 AVAIL. FOR 1p DOCUMENT TYPE: CLOUT FPAC: 83120502694 TASK; ODID DIN: 831129 DPN: .DRN:

DOCbET NO: 03000394 03002649 03014577 FICHE; 21381 195 -21381 196 RIDS: IEO7S 8312050271.. Notice of violation from insp on 831117. Noncompliance noted:

GM area surseys not performed wtelly in nuclear medicine &

cardiac hot labs FROM: BRENIAWSKI D.J, . Region 3 (Post 820201)

TO:

ISSUED: 831129 AVAIL: PDR 1p. DOCUMENT T YPE: TINVID FPAC: 8312050269A-T AS K :. ODI D. DIN: NVID-831129 DPN: DRN:

L ' DOCKET - tKL 03002649 FICHE: 21381 196 21381 196 RIDS':

i

. - - - . - . ~ . . ~ . - . - - , . . . . . - _ , _ . _ . . - . _ - . - . . _

__-,, .....--.--. _ -.~., - -

- _ _ . _ _ _ _ . _.m__ -. _ . _ _ . _ . _ . _ _ _ _ . . _ . _ _ . _ . - _ _ . _ _ . . _ . _ _ _

i 0/20/92 PAGE 2 U. S. NUCLEAR REGULAlORY COMMISSION _ j DCS PARTIAL RECORD FORMAT REPORT i 8312200284 Responds to NRC 031129 ltr te violations noted in IE insp i of License 34-OO466-01. Corrective ac tions. p ersonnel informed ;

that hot labs in nuclear medicine & cardiology depts must be surveyed on weekly basis-FROM: ARON.S.J. Cleveland Citnic Foundation, Cleveland, OH. ;

TO: SRENIAWSKI,D.J. Region 3 (Post 820201)

I SSUED: 831205 AVAIL: PDR 1 p. DOCUMENT TYPE: CLINC FPAC: 83122OO27DA TASK: ODID: DIN: 831205 DPN: DRN:

DOCKET NO. 03002649 FICHE: 21575 350 21575 350 RIDS:

G312200278 Ack receipt of 831205 Itr informing NRC of steps taken to correct vio:ations noted in IE insp of Licens= 34-00466-01.

FROM: SRENIAWSKI.D.J. Regton 3 (Post 820201)

TO: ARON,S.J. Cleveland Clinic Foundation. Cleveland, OH ISSUED: 031215 AVAIL: PDR 1p, DOCUMENT TYPE: CLOUT FFAC: 8312200270* ,

TASK: ODID: DIN: G31215 DPN: DRN:

DOCKET NO. 03002649 F1CHE: 21575 349 21575 360 HIDS: IEO7S B409130471 Application ior amend to License 34-OO466-01, naming SJ Aron '

radiation safety officer t. requetting possession of Gd-153 for human ust Documentation re SJ Aron qual:fications e nc 1.

Fee paid.

FRGM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 020201)

ISSUED; G40619 AVAIL PDR 14pp DOCUMENT 1YPE- TLAMBL FPAC. 0409130467D TASK: ODID" 77040 D I N .- AMDL-S40619 DPN; DRN:

DOCKET ND 03002649 FICHE' 25465 069 26465 002 RIDS; E409130467 Amend 20 to License 34-00466-01 for Cleveland Clinic Foundat1cr. naming SJ Aron as radsatiun saf + ty of fic or-FROM: HOLT,D.J. Region-3 (Post 820201)

TO:

ISSUED: 840916 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMSL FPAC: 84091304674 TASK: ODID' DIN: 34-00466-01 DPN: A28 DRN:

DOCKET NO: 03002649 FICHE; 26465 065 26465 082 RIDS: - ML3OL G409130469 Forwards Amend 29 to License 34-OO466-01. Info given in support _of iequest for.use of Gd-153 in humans. insufficient for review Addl info required listed.

FROM: HOLT, D. -J. Region 3 (Post G20201)

TO: AR ON, S. J. Cleveland'C11nic Foundation, Cleveland, OH ISSUED: 840816 AVAIL: PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 9409130467A TASK:- OD 10:- DIN: 840816 DPN: DRN:

DOCKET NO: 03002649 FI CHE: 26465 066 26465 068 P.!OS:

w- w.e=-> g+ a, re -w, ,-2 e,. ., g v **w ,-w -e i-T~ t w e =-*-ww*+-at=mee=-1 -w eee e -w-' r t-" t o - =-- m e--v ' rr ee-w w r=w -% -

r-w w w -v-e ,te -r w er- e "ra'-m'*-evw-e- W

8/20/92 PAGE 3 U S. NUCLEAR REGULATORY COMMISSION DC5 PARTIAL RECORD FORMAT REPORT t

'G412050778 Forwards addl-info re 840619 application to amend License 34-OO466-01,in response to 840816 request. '

FROM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH

-TO: HOLT,0.J. Materials Licensing Dranch-IGSUED: 840924 AVAIL: PDR 7pp. DOCUMENT TYPE: CLINC FPAC: '8412050764B TASK: OD1D: 77040 DIN: 840924 DPN: DRea DOCKET NO: 03002649 FICHE: 27779 216 27779 222 RIDS; '

B412050778 01 Forwards addl info re 840619 application to a rne n d License 34-OO466-01,in response to 840816 request.

FROM; ARON,S,J. Cleveland Clinic Foundation, Cleveland, OH TO- HOLT,0.J. Materials Licensing Branch

' I SCUED: 840Y24 AVAIL; PDR- 7pp. DOCUMENT TYPE: CLINC FPAC: 84120SO764D TASK: ODID: 77935 DIN- 840924 DPN: DRN; DOCKET NO: 03002649 FICHE: 27779 216 27779 222 RIDS:

04120D0764 Amend 29-to L2 cense 34-00466-01 for Cleveland Clinic Foundation,nuthorizing use of 3 Ci Gd-153 in Lunar Radiation Corp spine scanner,Model DP3,for bone mineral analy61c of human I vmte r spine FROM: HOLT.D.J. Region 3 (Post 82C201)

.10; ISSUED; G41023 AVAIL: PDR 2p p. DOCUMENT TYPE: TLLMBL FPAC: 8412050764*

TASK: ODID ' DIN: 34-00466-01 DPN: A29 DRN; DOCKET NO 03002649 FICHE- 27779 212 27779.222 RIDS: ML3OL 8412000770 Forwards Amend 29 to License 34-00406-01 Lacense conditions noted.

FROM: HOLT,0.J. Region 3 (Post 820201)-

TO: ARONf5 J. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 841023 AVAIL. PDR 2pp. DOCUMENT TYPE: CLDUT FPAC: 8412050764A- <

TASK: ODI D: DIN; 841023 DPNi DRN:

DOCKET NO' 03002649 FICHE: 27779 214 27779 215 R!DS:

8612O20575 . Forwards application for. renewal of License-34-OO466-01. Fee-paid.

FROM: ARON,S.Jc Cleveland Clinic Foundation, Cleveland, OH T O:- .

Region 3 (Post-1820201)

ISSUED: OD0118 AVAIL: PDR_ 2p p. -DOCUMENT TYPE: CLINC FPAC: 8612O20477H TASK: DDI D: 78168 DIN: 8S0118 , DPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 117 38785 270 RIDS:

2

, . . _ . . , . _ _ . __.-.-_.__,.___ _ _.2.. _ _ a _ _ _ _ _ . _ , . _ _ _ _ _ _ _ . _ . . - _- _..

8/EO/92 PAGE 4 r U. S. NUCLE.4R REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 0612O20583 Application for renewal of License 34-OO466-01,authortring use of any byproduct metl w/ Atomic Numbers 3 through 83, inc lusive t< - any matl listed in Groups I-VI of Schedule A to ;

10CFR35.100.

FROM: HARTWELL,S.W. Cleveland Clinic Foundation, Cleveland, OH TO:

ISSUED: 050118 AVAIL: PDR 153pp. DOCUMENT TYPE: TLAMDL FPAC: 8612O20477HA TASK: OD1 D: DIN: AMDL-850118 DPN: DRN:

DOCKET NO: 03002649 F I CHE: 33785 118 38785 270 RIDS:

r

~ 8612O20560 Amended application for renewal of License 34-00466-01, authorizing use of Ir-192 scaled source seeds encased in nylun ribbon & designating JP Santon & JR Little as members of medical isotope committee members FROM: ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH ,

TO: Region 3 (Post 820201)

ISSUED: 800205 AVAIL: PDR 12pp. DOCUMENT TYPE: TLAMBL FPAC: 8612O20477F TASK: ODID: 78168 DIN. AMBL-850205 DPN DRN:

DOCKET NO. 03002649 F1CHE 38785 104 38785 - 110 RIDS:

D612O20564 Ack receipt of application for renewal of License -

34-00466-01.

FROM- MALLETT,B.S, Region 3 (Post 820201)

TO: APON,S.J. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 850226 AVAIL: FDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8612O20477G TASK: ODID: 70168 DIN- 850228 DPN; DRN:

DOCKET NO. 03002649 FICHE. 38785 116 38785 116 RIDS: ;

8511270197 Notifies of new addrest 'to ensure deliverg to-correct location within foundation FROM; ARON,5.J. Cleveland-Clinic Foundation Cleveland, OH TO' GTAN3DURY,T.R. NRC - No Detailed Affiliation Oiven ISSUED: 850924 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8511270184A TASK; ODID: 79941 DIN: 850924 DPN; DRN:

DOCKET NO. 03000394 03002644 03017931 F ICHE: 336461103 ~33646 103 RIDS:

8511270191- Amend 30' to License 34-00466-01 for Cleveland--Clinic Foundation, changing address.

FROM: ADAM,W J, Region 3 (Post 820201). _

- TO:

ISSUED. 851105 AVAIL: PDR 1p. . DOCUMENT TYPE- TLLMBL FPAC: 8511270191 TASK.: ODID: DIN: 34-00466-01 DPN: A30 DRN:

DOCKET NO: 03002649 FICHE: 33646 303. 33646 304-RIDS: ML3OL w-.,,.% - - - . . -

7y._.,. m~.,,, y---+--.-. --r-,,,. -, - , . , . - . , . . , - - , ,,,.cy., ,, .,.-,,,_,_.,w, ,,.y m,.-y--.,_ .-.# . . - .,-+.,.-..-..4..4,...., e

6/20/92 PAGE 5 U. S, NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 0512240052 Discusses safety insp of Licenses 34-00466-01 h 34-00466-02 on 051205 L 06 & forwards notice of violation. Actions described in 831205 Itr te apparent items of noncompliance found during 831117 insp esamined.

FROM: W1EDEMAN.D.G. Region 3 (Post 820201)

TO: EVERSMAN,J.J. Cleveland Clinic Foundation. Cleveland. OH ISSUED: 051220 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8512240052*

TASK: ODID: DIN: 851220 DPN: DRN:

DOCKET NO: 03000394 03002649 FICHE: 34030 226 34030 227 RIDS: IEO7D OS12240050 Notice of violation from insp on 851205 & 06 Violation ~

noted: failures to perform daily GM area surveys or weekly wipe tests in nuclear medicine or cardiac hot labs.

FROM: WIEDEMAN,D.G. Region 3 (Post 820201)

TO:

ISSUED: 031220 AVAIL: PDR 2pp. DOCUMENT TYPE: TINVID FPAC:. 8512240052A TASK: ODID- DIN = NV1D-851220-01 DPN: DRN:

DOCKET NO: 03002649 FICHE- 34030-227 34030 227 RIDS:

0601010035 Addresses c omp 11.a n c e w/NRC requirements. Records show that preparation b injection areas surveyed wee 61 9 using low range,end window survey meter.Di yuarly wipe test survey not completed for Last Half 1985 due to manpower shortage.

FROM: AFCN,5 J Cleveland Clinic Foundation. Cleveland, OH TO: W1EDEMAN,D.G. Region 3 (Post 820201)

ISSUED: 660107 AVAIL- PDP 7pp DOCUMENT TYPE. CLINC FPAC: 8601310035*

T ASK: OD 1 D . D1N' 860107 DPN: DRN:

DOCKET NC 03002649 FICHE: 34426 313 34426 320 RIDS: IEO7D

~

'9604030353 Application (or arend t c: License 34-OO466-01, authorizing disposal o f- St-90 sealed source prevsoutly used as beta eye applicator b Ir-192 seeds in lead shielding containers Fee paid.

FROM: ARON,5 J. Cleveland Clinic Foundation. C l e v e l a re d . OH TO. Region 3 (Post 020201) _ _

ISSUED: G60109 AVAIL: PDR 3pp. DOCUMENT TYPE: TLAM3L FPAC: 8604030349A TASK: ODID: 80467 DIN: AMBL-G60108 DPN: DHN:

DOCKET NO -03002649 FICHE: 35400 166 35400 - 169 RIDS:

8601310039 Ack receipt of 860107 Itr informing NRC of steps taken.to correct' noncompliance noted in insp of Licenses 34-00466-01

& 34-00466-02 on 851205-06 Daily survey of hot lab & program not included in 740719 application. Noncompliance voided.

FROM: NIEDEMAN,DcG. Region 3 (Post 820201)

TO: EVERSMAN,J.J. Cleveland Clinic Frundation, Cleveland. OH ISSUED: 860128 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8601310035A TASK: ODID: DIN: G601~8 DPN: DRN:

DOCKET NO: 03000394 03002649 FICHE: 34426 320 34426 320 RIDS:

B/20/92 PAGE 6 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 8604030349 Amend 31 to License 34-00466-01 for Cleveland Cifnic Foundation, amending Subitems 6K,7K 6 BK to authorize use of 3 C1 Gd-153 in Lunar GD series seated source.

FROM: MCCANN,G.M. Region 3 (Post 820201)

TO:

ISSUED. 860128 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMDL FPAC: 8604030349*

TASK: ODID: DIN: 34-00466-01 DPN: A31 DRN:

DOCKET NO: 03002649 FICHE: 35400 165 35400 169 RIDS: ML3OL 8607300225 Application for amend to License 32-OO466-01 incorporating-changes in isotope c om:ni t t e e memb er s h ip & revs to 860107 info re exposure rate & contamination survey data. Supporting documentation encl. Fee paid.

FROM: ARON,5 J. Cleveland Clinic Foundation, Cleveland, OH TO: Regton 3 (Post 820201)

ISSUED: 860429 AVAIL: PDR 4pp. DOCUMENT TYPE: TLAMBL FPAC: 86073OO220A-TASK: ODID. 81258 DIN; AMBL-860429 DPN: DRN:

DOCKET NO: 03002649 FICHE: 37312 000 37312 003 RIDS; B607300220 Amend 32 to Lacense 34-00466-01 for Cleveland Clinst Foundatson. amending Condititn 23 i e conduct of licensed matis ptogram.

FROM. MCDONALD C.F Regton 3 (Post e20201)

TO-ISSUED. GOOS 27 AVAIL: PUR 19 DOCUMENT TYPE. TLLMDL FPAC; 8607300220+

TASK' ODID DIN: 34-00466-01 DPN: A32 DRN:

DOChET NO 03002647 FICHE: 37312 079 37312 083 RIDS; ML3OL

~

6612O20S45 nequestr, 1; stoa adol info in order t o c ontinue review of 850118 applac4 tion for renswal-of License 34-DO466-01. Record of 851024-telcon encl.

FROM: ADAM 4 W J. Region 3 (Post G20201)-

TO. ARON.S.a Cleveland Clinic Foundation, Cleveland, OH ISSUED: 860701 AVAIL PDR 4pp. DOCUMENT TYPE; CLOUT FPAC: 8612O20477E TASK: ODID. 70168 DIN' 860701 OPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 100: 38765 103 RIDS:

8612O20S36 Informt that 14 cense mny be t er minated if response to - 860701-request for addl info tr- GSO119 epp11tation for tenewal of License 34-00466-01 not rece ved within 30 days-FROM: MALLETT,B.S. Region 3 (Post.820201)-

TO: ARON,S.J. 1 Cleveland Clinic Foundation, Cleveland,- OH ISSUED: 860805 AVAIL; PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8612O20477D TASK: OD1D-: 78160 DIN: 860805 DPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 099 38785 099 RIDS:

G/20/92 PAGE 7 U S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT B612O20511 Responds to SeO60S Itr.Thtrty-day eatension until end of Aug granted,per 060729 telcon w/W Adam.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: VACHERLON,P. Region 3 (Post 020201)

ISSUED: 860808 AVAIL. PDR 1p. DOCUMENT . TYPE: CLINC FPAC: 8612O20477C TASK: ODID. 78168 DIN: 660008 DPN; DRN:

DOCKET NO: 03002649 FICHE: 38785 098 30785 098 RIDS:

8612O20490 Responds to 060701 tequent for addl info re License 34-OO466-01.A11 thetopy dotes of liquid 1-131 opened inside -

nuclear medicine dept radiation fume hood by personnel weoring gloves.

FROM: ARON S.J. Cleseland Clinic Foundation, Cleveland, OH

- TO: ADAM W J Region 3 (Post 020201)

ISSUED: 860813 AVAIL: PDR Spp. DOCUMENT TYPE: CLINC FPAC: 861PORO477D T ASK: ODID 78160 DIN; 060013 DPN: DRN:

DOCKET NO. 03002649 F I CHE : 30705 093 38753 097 RIDS:

G612O20490 YA Responds to 960701 request for addl info re License 34-00466-01,All therapy doses of liquid I-131 -opened inside nuclear medicine dept radiaticn fumo hood by personnel wearing gloves.

- FROM: ARON.E J Cleveland Clinte Foundation, Cleveland, OH TO: ADAM,W.J. Region 3 (Post G20201)'

ISSUED E60913 AVAIL F1;R 37pp DOCUMENT TYPE: CLINC FPAC: 92"3060423A TASK- ODI D: 76168 DIN: G60813 DPN: DRN:

DOCKET NO 03002649 FICHE' 60C99 065 60099 101 RIDS:

0612O20477 Ar end 33 to ticente 3A-OO466-01 for C1cveland Clinic Foundation, amending 11 cense in entartty FROM: ADAM. W. J R e g i ore 3 (Post 820201)

TO:

ISSUED. 060910 AVAIL: PDR 6pr DOCUMENT TYPE. TLLMBL.FPAC: 8612O20477*

T ASK: OCID- DIN: 34-00466-01 DPN: A33 DRN:

DOCKET ND, 03002649 F I CHE: 38785 086 38785 270 RIDS: ML3OL 0612O204GO Forwards Amend o2.reaewing License 34-OO466-01. Lunar Radiation Corp Model SP2 not specifically listed on license.

Since nif g issued medical distributton license to distribute device to licensees authorized to possess Group V!'matis-FROM- ADAM,W_J. Regton 3 ( P o t t- 820201)

.TO: ARON,S J.- Cleveland Clinic Foundation. Cleveland, OH ISSUED: 860910 AVAIL: PDR. 2pp. DOCUMENT TYPE: CLOUT .FPAC: 8612O20477A TASK: ODID: DIN: G60910 DPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 091 30705 092 RIDS:

. _ _ _ . _ . _ _ _ _ . _ . _ . _ . _ _ . _ _ _ _ . _ _ . ~ . . . _ _ _ _ . . _ _ _ _ _ _ _ ._ _ ____..

I l

l O/20/92 PAGE D V S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMA 1 REPORT l

l a

0610070425 Confirmatory action 1tr requiring that planned esperiment to implant Ir-1V2 brachytherapy sources in pigs not be a performed until problems encountered during similar work at Univ of Nisconsin analyzed & NRC final rept reviewed.

FROM: KEPPLER.J.G. Region 3 (Post 820201) i TO: ARON,S. Cleveland Clinic Foundation. Cleveland, OH j ISSUED: 860926 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT- FPAC: 8610070425 1

TASK: ODID: CAL DIN: 860926 DPN: DRN:

I DOCKET NO: 03002649 FICHE: 38119 300 38119 339 RIDS: IEO7D 0702030195 Responda to D61120 confirmatory action ltr re Co-60 l misadministration r ep or te d on 061117 Summary of 10CFR35.42 prepared t, method of reporting within institution trsf f ir med.

OM: THOMAS,F.J. Clevtland Citnic Foundation, Cleveland, OH TO KEPPLER,1 O Region 3_(Post B20201) l ISSUED- 061218 AVAIL- PDR 10pp. DOCUMENT TYPE: CLINC FPAC: 87020SO171A j DPN:

TASK: ODID: CAL DIN. 861218 DRN:

DOChET NO. 00000394 03002649 FICHE: 39512 322 39512 339 RIDS:

8702050195 XA Responds t o fm1120 confirmatory action Itr te Co-60 misadministratton reported on 661117. Summary of 10CFR35.42 prepared fs nethod of reparting wtthin instttution r e a f f i l tr e d FROM. THOMAS.F J Cleveland c l i n t t: Fevndation, Cleveland, OH TO: AEPPLER,J.G. Region 3 (Post G20201) c 1SSUED 86: 218 AVAIL. PLR 6pp- DOCUMENT TYPE: CLINC FPAC: 92061GO358A C TASK' OD1D- CAL DIN. 861218 DP N :- DRN:

DOCKET Na 0300C094 03OO264c FICHE 62105 002 62103 087 R '.DS:

07020501'i Responds to 861218 tubmittel of new proposed radiation ther ap y GC/GA program Revaev concluded that listed areas should be revised or c li.st i f i e d; R e t r on t e r equ e t t e d within 30 days. ,

FROM: HIND. J A Region 3 (Post 820201)

TO: lHOMAD,F J Cleveland Clinic Foundation. Cleveland, OH I SSUE D- 870126 AVAIL PDR 3pp_. DOCUMENT TYPE- CLOUT FPAC: 8702050171*

TASK' ODID DIN: 870126 DPN: DRN:

DOCKET NO 03000394 03002640 FICHE: 39512 319 39S12 339 RIDS: IEO7D 8704220107 Forward 5 radtation safety incident rept re release of radioactive a s h o t; from incinerator room, reported on 870206.

Loss of licensed mati does not appear to be substantial hazard to persons in unrestricted-areas.

FROM: ARONiS.J. Cleveland Clinic Foundation, Cleveland, OH TOi W1EDEMAN,D_ Region 3 (Post'G20201) -

ISSUED: 870212 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC: 8704220130D TASK: ODID. _ _

DIN: 870212 DPN: DRN:

t DOCKET NO: 03000394 03002649 03014377 FICHE: 40620 143 40620 14S R1DS:

, p .% f w-w.y.y% a. m-, ,*m-.pp um.. . ,,e-s_ _,,,,.a "tw v.e w w- w f, -.n.r*v-we-=w e*-w e

___....___-m._._.__.__ . _ _ _ .._ _ _ _._ _ __ _ . _ - - _ - _ _ _

G/20/92 PAGE 9 ;

U. 5 NUCLEAR REGULATOR Y COMMISSION !

DCS PART!AL RECORD FORMAT REPORT l G704220107 XA Forwards radiation safety inc ident rept ce release of [

radioat tve ashes from incinerator room, reported on 870206. l Loss of licensed mati does not appear to be substantial l hatard to persons in unrestricted areas. i FROM: ARON,5,J. Cleveland Clinic Foundation, Cleveland, OH TO: WIEDEMAN D. Region 3 (Post 820201)

DOCUMENT TYPE: CLINC FPAC: 9207000132A ISSUED: 870212 AVAIL: PDR 3pp. ;

TASK: ODID: DIN- 070212 DPN: DRN: l DOCKET NO- 03000394 03002649 03014377 FICHE: 62262 130 62262 137 RIDS: l 8704220166 Responds to 070126 lir, modified by G70304 enforcement conferer.ce.Licentee offers to amend L'*.enses 34-00466-01, 34-00466-02 h 34-00466-03 to 2nclude enc 1 OA/OC statement of principles for dept of Tadiation therapy.

FROM: KI5!!R, W S. Cleveland Clinic Foundation, Cleveland, OH TO: HIND,J A Region 3 (Post G20201)

ISSUED: 070313 AVAIL: PDR 7pp. DOCUMENT TYPE: CLINC FPAC: 8704220130C ;

T ASK; ODID DIN: 870313 . DPN. DRN: l DOCKET NO 03000394 03002649 03014577 FICHE: 40620 136 40620.142 RIDS:

G704220166 YA R e t. p o n d t to 870126 ltr, modified by 870304 enforcement conf erenc e L teensee offers to amend Licenses 34-00466-01, 34-00466-02 & 34-00466-03 to include enc 1 OA/OC 5tatement of ;

principles for dept of radiation therapy.

FROM: KISER,W.S. Cleveland Clinic Foundation, Cleveland, OH 2 TO: HIND,J,A. Regton 3 (Post 820201) 15 SUED: 870313 AVAIL: PDR 7pp. DOCUMENT TYPE: CLINC FPAC: 9207060132A TASK: ODI D- DIN; 870313 DPN: DRN:

DOCKET NO 03000394 03002649 03014977 FICHE' 62262 123 62262 129 RIDS:

8704220130 For war d s Ssfety Into Repts 30-02649/07-01,30-00394/97-01,30-14S" /87-01,30-17931/07-01 5, 70-3044/07-01 on 070323-23 L !

notice of violation Concern te mgt control cys expressed L 1 stp r o v e m e r,t s requelted FROM* AVELSON,W.L. Region 3 (Post 820201)- '

TO: KIEER,W S Cleveland Clinic Foundation Cleveland, OH IGBUED. D70415 AVAIL: PDR 2p p. DOCUMENT TYPE- CLOUT FPAC: 8704220130*

TASK; ODID: DIN: 870415-01 DPN: DRN:

i DDCKET N3 03000394 03002647 03014577 FICHE: 40620 116 40620 145 RIDS: IEO70 G704220130 XA Forwards Safety insp Repts 30-02649/87-01,30-00394/07-01, ,

I 30-14577/07-01,30-17931/87-01 & 70-3044/07-01 on 870323-25 &

I notice of violation. Concern te mg t control sys espressed 6 improvements requested. . ;

FROM: AYELSON,W.L. Region 3 (Post 020201)

TO: K I EER , W. S. Cleveland Clinic Foundation, Cleveland, OH

-ISSUED: 870415 AVAIL. PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9207080132A

-TASK: ODI D: DIN: 870415-01 DP N: DRN:

DOCKET NO: 03000394 03002649 '03014577 FICHE: 62262 103 62262 137 RIDS; IEO7D

?

)

G/20/92 PAGE 10 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORf1AT REPORT G704220146 Notice of violation from insp on 070323-20 FROM: AXELSON,W.L. Region 3 (Post 020201) '

TO:

ISSUED. 090415 AVAIL: PDR 6pp. DOCUMENT TYPE: TINVID FPAC: 8704220130A TASK: ODID. 30-02649/87-01 DIN: 30-00394/07-01 DPN: DRN; DOCKET NO, 03000394 03002649 03014577 FICHE: 40620 118 40620 123 RIDS:

D704220146 XA Notice of violation from insp on 870323-25.

FttOM: AXELSON,W L.4 Regton 3 (Post G20201)

TO:

ISSUED: 87041D AVAIL: PDR 6pp. DOCUMENT TYPE: TINVID FPAC: 9207000132A TASK: ODID 30-02649/07-01 DIN: 30-00394/07-01 DP N. DRN:

DOCKET NO. 03000394 03002649 03014977 FICHE: 62262 105 62262 110 RIDS:

07042201S8 Insp Repts 30-02649/07-01 30-00344/G7-01,30-14577/07-01,.

30-17931/87-01 t 70-304r/07-01 on 070323-25. Violations noted: f ailur e to conduct senuannual audits, conduct monthly Surveys, maintain rucords ti post caution signt FROM: LYNCH,J L Region 3 tPost 820201)

TO:

ISSUED: 870415 AVAIL. PDR 12pp. DOCUMENT 1YPE: T11NSP FPAC: 8704220130D TASK- ODID 30-0264Y/07-01 DIN. 30-00394/D7-01 DPN: DRN:

DOCKET NO- 03000394 03002649 03014577 F I CHE: 40600 124 40620 135 RIDS:

G70422015G XA Insp Reptt 30-02649/87-01,30-00394/07-01,30-14577/87-01.

30-17931/87-01 t 70-3044/S7-01 on G70323-25.V1014tions noted:fallure to conduct semtannual-audtts, conduct monthly Surveys, maintain records fx post caution signs.

FROM: LYNCH,J.L. Region 3 (Post 820201)

TO:

ISSUED: .870415 AVAIL- PDR 12pp DOCUMENT TYPE: T11NSP FPAC: 9207000132A TASK: ODID: 30-02649/07-01 DIN: 30-00394/07-01 DPN: DRN; DOCKET NO: 03000394 03002649 03014377 FICHE: 62262 til 62262 122 RIDS:

89011001% Application for emend to Licente 34-00466-01, authorizing use of Siemens bone mineral densitometer.Related info enc 1.

Fee paid.

FROM; ARON G.J. Cleveland Clinic Foundation. Cleveland, OH TO: MCCANN,G,M. Region:3 (Post 820201)

ISSUED: G70429 AVAIL: PDR- :13pp. DOCUMENT. TYPE: TLAMBL FPAC: 80011201GDD TASK: ODID: 83318- DIN! AMDL-870429 DPN: DRN:

DOCKET NO: -03002649 FICHE: 43990 183 43990 196 RIDS:

]

O/20/92 FAGE 11

-U S. NUCLLAR RLGULATORY COMMISSION DCS PARTIAL RF. CORD FORMAL REPORT B001120192 Forwards addl info to be included w/870407 application for emend to License 34-OO466-01. Limit for I-12S should be increased to 1,000 mC1 FROM: ARON,5.J Cleveland Clinic Foundation, Cleveland, OH TO: MCCANN,G.M. Region 3 (Post 920201)

I SSUED: 870500 AVAIL: PDR 10pp, DOCUMENT TYPE: CLINC FP AC: 8001120185C TASK: ODID: 83518 DIN. 870500 DPN: DRN:

DOCKET NO: 03002649 FICHE: 43998 173 43998 182 RIDS: ,

G801120189 Application for amend to License 34-00466-01, permitting '

radiation safety offtcer to determine number of classes !

personnel must attend for basic radiation safety seminar.

series.

FRON: AROf L S. J. Cleveland Clinic Foundation, Cleveland, OH :

TO: MCCANN,G. Region 3 (Post 020201)

ISSUED: 870513 AVAIL: PDR 1p. DOCUMENT TYPE- TLAMBL FPAC: 8001120105D.

TASK: OD10: 83518 DIN: AMUL-870S13 DPN: DRN:

DOCKET NO: 03002649 r!CHE- 43998 172 43990 172 RIDS:

0801260563 Application for amend to License 34-00466-01, changing membership of t h d i o i t. o t o p e- O rad 14tson safety committees as ,

listed Fre paid i

FROM' AFON.G J. Cleveland Clinic Foundation. Cleveland, OH TO: Region 3 (Post B20201) i ISSUED: 870716 AVAIL. PDR 1p. DOCUMENT TYPE TLAMBL FFAC. BOO 1260559A .

I

, TASK? OD I D. B3C67 DIN: AMBL-870716 DPN. DRN:

DOCHET NO. 03002649 FICHE: 44125 113 4412S 113 RIDS-0801120105 Amend 35 to License 34-00466-01 for Cleveland Clinic Foundation,authorir2ng usr of GOO mci 1-125 in Osteon,Inc 4 Model SPHAK7X bone mineral analyrer.

FROM: MALLETT D.S. Region 3 iPo;t 020201)

TO:

1 SSUED: 870717 AVAIL: PDR 2pp DOCUMENT TYPE: TLLMBL FPAC; 880112010S*

TASK: ODI D: DIN: 34-00466-01 DPN: A35 DRN:

DOCKET NO. 03002649 FICHE: 43998 160 43990 196 RIDS: ML3OL-0801120107 Forwards Amend 3D to Licente 34-OO466-01. Changes in radioitotore committer not authorited. Condition 1 1. A -

c orr e c t t'd to authorire RT Go as' chairman of committee L survey requ2 red for old nuclent med2:ine O cardiology areas,

FRDM: MALLETT,B.S Region 3 (Post 8202i" TO: ARON.S,Jc Cleveland Clinic Foundation, C;eveland, OH ~ l ISSUED: G70717 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT. FPAC: 860112010SA TASK: ODID: DIN: 870717 DPN: DRN:

. DOCKET NO: 03002649 F IC HE; 43998 170 43999-171 RIDS:

. . . . . ~ , . _ _ . _ . . . . . _ _ _ . _ . - .2,,.- _ ._ ....,_m.__._ _ _ _ . . . . _ _ . . _ , , . ~ . . . - - . . - .

B/20/92 PAOE 12 U. S. NUCLEAR REQULATORY COMMISSION DCS FARTIAL HECORD FORMAT REPORT 0001260559 Amend 36 to License 33-00466-01 for Clevelend Clinic Foundation, changing Condition 16 te conduct of program.

FROM: MADERA,J.R. Region 3 (Post 820201)

V0:

ISSUED: 070003 AVAIL: PDR 1p DOCUMENT TYPE: TLLMDL FPAC: 8901260559*

TASK: ODID: DIN: 34-00466-01 DPN: A36 DRN:

DOCKET NO 03002649 FI CHE: 44125 112 44125 113 RIDS: ML30D 0910100329 Application for amend to License 34-00466-01, authorizing ,

J MacIntyre as senior consultant & establishing stated quorum.

FROM: ARON.S J. Cleveland Clinic Fo ndation, Cleveland, OH TO: MALLETT,B.S. Region 3 (Post 820E01)

I GSUED: 070012 AVAIL: PDR 160pp. DOCUMENT 1YPE: TLAMDL FPAC: 8910100257A-T ASK: ODID: 04067 DIN: AMBL-870812 DPN: DRN:

DOCKET NO- 03002649 FIC HE : 51524 207 51525 006 RIDS:

8910100329 01 Application for amend to License 34-OO466-01,authortring J MacIntyre as sentor consultant & establishing stated quorum.

FROM. ARON.S J, Cleveland clinic Foundation, Cleveland, OH TO: MALLETT,D.S. Region 3 (Post 820201)

ISSUED. 870012 AVAIL PDR 149pp. DOCUMENT TYPE: TLAMDL FPAC: 8910180257A TASK: ODI D: 03867 DIN: AMBL-G70812 DPN: DRN:

DOCKET NO- 03002649 FICHE: 51524 287 S152b 006 HIDS: ;

G902140131 Application for amend to License 34-00466-O! authorizing use ,

of 500 mCt H-3 L I-121 & 300 mC1 Cr-51. Foe paid.

T FROM: ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH T O: Region 3 (Post G20201)

I SSUED: 871130 AVAIL: PDR Spp DOCUMENT TYPE: .TLAMBL FPAC: 8902140122D T ASK: ODID: 384563 DIN: AMDL-871130 DPN: LR N:-

DOCKET NO: 03002649 F1CHE; 48730 119 48730 126 RIDS:

8902140122 Amend 3? to Litense 34-00466-01 for Cleveland Clinic F ound a t a on, ,3 u t h or i r a n g ute of.500 mci H-3 84 500 mci 1-125; ,

FROM: - MAT SDN. E. R. Region 3 (Pott 820201)

TO:

ISSUED: 080310 AVAIL: PDR 1p. DOCUMENT TYPEr TLLMDL FPAC: 8902140122*

TASK: ODID: 384563 DIN: 34-00466-01 DPN: A37 DRN:

DOCKET NO! 03002649 FICHE: 48730 114 48730.126 RIDS: ML30D

8/20/92 PACE 13 U. S. NUCLEAR REGULATORY COMMISSION l DCS PARTIAL RECORD FORMAT REPORT

)

0902140126 Forwards Amend 37 to License 34-00466-01.

FROM: MAi3ON,E.R. Region 3 (Pott 020201)

TG: ARON.S J Cleveland Clinic Foundation, Cleveland, OH ISSUED. 08031'; AVAIL: PDR 4pp. DOCUMENT TYPE l CLOUT FPAC: 8902140122A t

7ASK: ODID: 304563 DIN: 000310 DPN: DRN:

ODUKET ND: 03000649 FICHE: 48730 11S 48730 118 RIDS:

0904030S16 Application for amend to License 34-OO466-01 authorizing listed individuals es radioisotope & re'iation safety committee. Fee paid.

FROM: ARON,S J. Cleveland Clinit Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: DOO314 AVAIL: PDR 2pp. DOCUMENT TYPE: TLAMBL FPAC: 89040 BOD?3A TASK: ODI D: 85047 DIN: AMDL-G80314 DPN: DRN:

DUCKET NO: 03002649 FICHE: 49399 135 49399 136 RIDS:

G904050513 Amend 38 to License 34-00466-01 for Cleveland Clinic Foundation, authorizing use of listed licensed matl FROM: WHISTON,P.J. Region 3 (Post G20201)

TO:

ISSUED: 890407 AVA!L: PDR 2p p. DUCUMENT TYPE TLLMDL FP.AC : G904050513*1 T ASK : UDID: DIN: 34-00466-01 DPN: A38 DRN:

DOCKET N3- 03002649 FICHE: 49399 133 49399 136 RIDS: ML30D 9207210316 Informs of e30317 mi, edmi ni s t ra t i on of raeiopnarm. Patient injected w/11.5 mci Tc-99m DTPA for renal scan. Caused by

. misunderstanding of referring p hy s i c i an r eque s t ' 8< no t cherking raquisition. Personnel reptimanded.

FROM: ARON,S.J. Cleve16nd Clinic Foundation, Cleveland, OH TO: WIEDEMAN,D. Region 3 (Post 820201)

ISSUED: 080320 AVAIL: PDR 2pp, DOCUMENT- T YPE: CLINC FPAC: 92071SO100A T ASK: ODID: _ DIN: 880520-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62546 044 62546 045 RIDS:

'9207210316 01 Informs of G80517 misadministration of radiopharm. Patient injected w/11.5 mci Tc-99m DTPA for renal scan. Caused by 3 misunderstanding of referring physician request 0 not checking requisition, Personnel reprimanded.

FROM: ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH TO: WlEDEMAN,D. Region 3 (Post 820201)

ISSUED: 080520 AVAIL: PDR 2pp, DOCUMENT TYPE: CLINC FPAC: 9207130108A-TASK: ODID: DIN: 880520 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62546 044 62546 045 RIDS:

bi .di gli. I i fisli

8/20/92 PAGE 14 U. S. UUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9207230114 Informs of 880721 misadministration of radiopharm. Patient injected w/20 mC1 Tc-0 instead of Tc-99m MDP. Caused by failure to read label & selection of wrong syringe, Personnel reinstructed.

FROM: ARON S.J. Cleveland Clinic Foundation, Cleveland. OH TO: WIEDEMAN,D, Region 3 (Post 820201)

ISSUED: 880728 AVAIL: PDR 2p p. DOCUMENT TYPE: CLINC FPAC: 92071SO108A-TASK: ODID: DIN: 880728-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62546 049 62546 050 RIDS:

12C7230114 01 Informs of 880721 misadministration of radiopharm. Patient -

injected w/20 mci Tc-0 instead of Tc-99m MDP. Caused by failure to read label & selection of wrong syringe. Personnel reinstructed, FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: W1EDEMAN,D. Region 3 (Post 820201)

ISSUED: 880728 AVAIL: PDR 2pp DOCUMENT TYPE: CLINC FPAC: 42071SO100A TASK: OD1D: DIN: 880728-01 DPN: DRN:

DOCKET NO: 03002649 FICHE- 62546 049 62946 OSO RIDS:

9006060377 Mat 1s licensing package for Arne n d 39 to License 34-00466-01 for Cleveland Clinic Foundati on. Contr ol: 383369 FROM: PELKE>P.J. Region 3 (Post 820201)

TO: D ISSUED: 881212 AVAIL: PDR 22pp. DOCUMENT TYPE: TLLMDL FPAC: _9006060377 T ASK: ODID 333369 DIN: 34-00466-01 DPN: A39 DRN:

DOCKET NO: 03002644 FICHE: S4002 027- S4002 040 RIDS: ML30D _

9004040203 Matis licensing package for Amend 40 to License 34-00466-01 for Cleveland Clinic Foundation. control: 366134.

FROM: PELKE,P.J. Region 3 (Post 820201)

TO:

ISSUED: 881219 AVAIL' PDR 7pp. DOCUMENT TYPE: 'TLLMBL FPAC: 900404020S TASK: ODID: 386134 DIN: 34-00466-01 DPN: A40 DRN.

DOCKET NO; 03002649 FICHE: 53240 100 S3240 106 RIDS: ML30D 9003130061 Matls licenting package for Amend 41 to License 34-00466-01 for Cleveland Clinic Foundati on Contr ol: 83789.

FROM: PELKE,P.J. Region 3 (Post 820201)-

TO:

ISSUED: 890113 AVAIL: PDR Spp. DOCUMENT TYPE: TLLMDL FPAC: 9003130061 T ASK; ODID: 83789 DIN. 34-00466-01 DP N: A41-DRN:

DOCKET NO: 03002649 F ICHE: S2921 048 S2921 052 RIDS: ML30D

- _ . . . - - - .;..., n _-- ,_-

8/20/92 PAGE 15 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9003130061 XA Mat 1s licensing package for Amend 41 to License 34-00466-01 f or Cleveland Clinic Foundation Control: 83709.

FROM: PELKE,P.J. Region 3 (Post B20201)

TO:

ISSUED: 890113 AVAIL: PDR Opp. DOCUMENT TYPE: TLLMBL FPAC: 9203060423A TASK: ODID: G3709 DIN: 34-00466-01 DPN. A41 DRN:

DOCKET NO: 03002649 FICHE: 60099 056 60899 064 RIDS:

9004260150 Matts licensing package for Amend 42 to License 34-00466-01 for Cleveland Clinic Foundation. Control: 306672, FROM: PELKE,P;J. Region 3 (Post 820201)

TO: ;

ISSUED: 890?22 AVAIL PDR 3pp. DOCUMENT TYPE: TLLMBL FPAC: 9004260150 ;

TASK: ODID: 3U6672 DIN: 34-00466-01 DPN: A42 DRN:

DOCKET NO: 03002649 FICHE: 53563 353 33563 3DD RIDS: ML30D 0910180257 Amend 43 to License 34~O0466-01 for Cleveland Clinic

-Foundation. amending Condition 16 to state that license based on licensee statements 34 representations in 870812 Itr.Related info, including 870012 ltr, enc 1m FROM: PELKE,P.J Region 3 (Post 820201)

TO:

I SSUED: 090310 AVAIL- PDR 10 DDCUMENT TYPE: TLLMDL FPAC: 8910180257*

TASK: ODID: 04067 DIN: 34-00466-01 DPN: A43-DRN:

DOCKET NO: 03002649 FICHE: 51524 285 51526 OB6. RIDS: ML30D ,

89101GO257 01 Amend 43 to License 34-00466-01 for Cleveland Clinic Foundation.omending Condttion 16 to state that license.

based on licensee statements & representations in 870612 ,

1tr.Related infoeincluding 870812 Itr, enc 1.

FROM: PELKE,P.J Region 3-(Post 820201) -'

TO:

ISSUED: G90310 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMGL FPAC: 9910100257+

TASK: ODID: 83967 DIN: 34-00466-01 -DPN! A43-DRN:

DOCKET NO: 03002649 FICHE: $1524 285- 51S25 086-RIDS: ML30D' 9006070371 Matls licensing package for Amend 44 to License 34-00466-01 for Cleveland Clinic Foundation. Control: 387975. ,

FROM: PELKE,P.J. Region.3 (Poet G20201)

TO:

I SSUED: 891003 AVAIL: PDR 4pp. -DOCUMENT. TYPE: TLLMBL,FPAC: 9006070371-TASK: ODID: 387975 DIN: 34-00466-01 DPN:.. A44 DRN; .

DOCKET-NO: 03002649 FICHE: 54048 129 54048 132 RIDS: ML30D

~ ._ _ _ _ __ _____. _ ___. _ _.m ._ . . . _ _ _ . _ _ _ . _ _. _ _ _ _ _ _ _ . _ . _ ..

G/20/92 PAGE 16 f U. S, NUCLEAR REGULATORY COMMISSION [

DCS PARTIAL RECORD FORMAT REPORT i

t 9206100367 Informs of 900102 mibadministration of radiopherm. Patient given 091 I-131 capsule for uptake & scan instead of 015 1-131 capsule for uptake b treatment. Corrective actions reviewed b retraining provided. Withheld.

FROM:

Cleveland Clinic roundation, Cleveland, OH TO: NRC - No Detailed Affiliation Given ISSUED: 900405 AVAIL PDR 1p. DOCUMENT T YPE: CLINC FPAC: 9206180321A i TASK: ODID: DIN: 900405 DPN: DRN: ,

DOCKET NO. 03002649 F I CHE: 62105 075 62105 076 RIDS:

9206100355 Responds to 900404 telcon request te investigation of '

anonymous allegations concerning potential diagnostic -

misadministration at facility on 900lO4. Corrective actions taken & explained in enc 1.

FROM: ARUfJ, S. d Cleveland Clinic Foundation, Cleveland, OH-TO: MATSON,E.R. Region 3 (Post 820201) '

IGSUED: 900406 AVAIL: PDR 2pp. DOCUMENT TYPE -CLINC FFAC: 9206100321A TASK: ODI D: DIN: 900406- DPN: DRN: ,

DOCKET NO. 03002649 FICHE 62105 073 62105 074 RIDS:

9005000120 Forwards safety Insp Repts 30-02649/90-01,30-00394/90-01, 30-14577/90-01 0 '/O-3044/90-01 on 900307-0405. Violations b

-repeat concern for lack of cooperation between therapy dept

& radiation safety ofe identified.

FROM: NORELIUS,C.E. Reg 2on 3 (Post B20201)

TO: LOOP.F. Clevejend C12nic Foundatson, Cleveland. OH

' I SSUE D: 900427 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9005080120*

T ASK: ODID EA-90-074 DIN: 900427 OPN: DRN:

DOCKET NO 03002649 03?OO394 03014577 FICHE. 53769 299 53769 351 R IDS: IEO7D '

9005080120 01 Forwards Safety Insp Repts 30-02649,'90-01,30-00394/90-01.

30-14577/90-01 & 70-3044/90-01 on 900307-0405. Violations &

repeat concern for lack of cooperation between therapy dept

& radiation safety ofc identified.

FROM: NCRELIUS C<E Region 3 (Post 820201)

TO: LOOP.F, Cleveland Clinic Foundation, Civveland, OH ISSUED: 900427 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9005000120*

TASK: ODID: DIN: 900427 DPN: DRN; DOCKET NO: 03002649 07003044 FICHE- 53769.299 03769 351 RIDS: IEO7D 9005000120 Safety Insp Repts 30-02649/90-01,30-00394/90-01, 30-14577/90-01 L 70-3044/90-01 on 900307-09,14-16 & 0313 &

19-0405. Major areas inspec tod: review of licenced programs, !

organization, internal audit-. program h notifications L repts.

FROM: MATSON,E.R. Region 3 (Post 820201) .

TO:

ISSUED: 900427 AVAIL: PDR 51pp. DOCUMENT TYPE: T11NSP FPAC: 9005080120A TASK: 001 D: 30-00394/90-01 DIN ^ 30-02649/90-01 . DP N: DRN; DOCKET NO: 03002649 03000394 03014577 FICHE: 53769 301 53769 351 RIDS:

0/20/92 PAGE 17 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RI-CORD FORMAT H1: PORT '

t 9005000128 01 Safety Insp Repts 30-02649/90-01,30-00394/90-01, !

30-14577/90-01 h 70-3044/90-01 on 900307-09,14-16 & 0313 b

$9-0405. Major areas inspected. review of licensed programs, organ 1:ation, internal audit program L notificottons & repts.

FROM: MATSONiE.R. Region 3 (Post 820201)

TO:

ISSUED: 900427 AVAIL; PDR 51pp. DOCUMENT TYPE: YIINSP TPAC: 9005000120A -

TASK: ODID: 30-14577/90-01 DIN: 30-02649/90-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 53769 301 53769 351 RIDS:

9005000120 02 Safety Insp Repts 30-02649/90-01,30-00394/90-01, 30-14577/90-01 0 70-3044/90-01 on 900307-09,it 16 & 0313 &

19-0405 Major areas inspected review of licensed programs, organitation, internal audit program & notifications & repts. !

FROM: MATSON,E.R. Region 3 (Post G20201)

TO:

ISSUED: 900427 AVAIL: FDR b1pp. DOCUMENT TYPE: 111NSP FPAC: 9005000120A ,

TASK: ODI D. 70-3044/YO-01 -DIN: 30-02649/90-01 DPN: DRN:

DOCKET NO. 03002649 F1CHE: 53769 301 53769 351 RIDS:

9005290279 Safety Insp Repts 30-02649/90-02 30-00374/90-02 h 30-14577/90-02 on 900307-09,14-16 & 0419-20. Violationt i noted. Major 6 teas inspected allegations received on 890829 re licensee.

TROM: MATSON,E.R Reglen 3 (Post 820201) '

TO:

I SSUE D: 900518 AVAIL: PDR 40pp. DOCUMENT TYPE. TIINSP.FFAC: 9005290275D !

TASK: ODI D 02649/90-02 DIN. 30-00394/90-02 DPN: DRN:

DOCKET NO: 03002649 03000394 03014577 FICHE: 53947 261 53947 300 RIDS:

9005290279 01 Safetg Insp Repts 30-02649/90-02,30-00394/90-02 &

30-14577/90-02 on 900307-09,14-16 & 0419-20. Violations noted. Major areas inspected: allegations received on 890829 re licensee. ,

FROM: MATSON,E R. Region 3-(Pott 820201) .

TO:

ISSUED: 900518 AVAIL: PDR 40pp. DOCUMENT ~ TYPE TI1NSP TPAC: 9005290275B TASK: ODI D: 30-14577/90-02 DIN: '30-00394/90 DP N :- -DRN; DOCKET NOL 03002649 FICHE: 63947 261 D3947 300 RIDS:

9005290275 Forwards Safety Insp Rtpts 30-02649/90-02,30-00394/90-02 &

30-14577/90-02 on 900307-0420 6 notice of violation. +

L FROM: NORELIUS,C.E. _ Region 3 ' Post 820201)

TO: -LOOP,F. Cleveland Clinic Foundation, Cleveland,-OH ISSUED: 900522 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9005290275* l TASK: ODID: DIN: 900522 DPN: DRN:

t DOCKET NO: 03002649 03000394 03014577 FICHE: 53947 257 ' 53947 300 RIDS: IEO7D l

l 1 ..

i

,._ - - - - ~ - .- - - _ .- --...- . _.. - - - .., - - .

0/20/92 PAGE 10 U. S. NUCLEAR RECULATORY COMMISSION i

DCS PARTIAL RECORD FORMAT REPORT 9005290276 Notice of violation from insp on 900307-0420. Violations 4

noted: failure to notify ret physician h NRC ofc in writing ;

l within 15 days of 900104 diagnostic misadministration b ;

failure to inform nuclear physician until 900404. ,

FROM: NORELIUS.C.E. Region 3 (Post 820201) 1 TO: ,

ISSUED: 900522 AVAIL: PDR 2p p . DOCUMENT TYPE: TINVID FPAC; 9005290275A i T ASK: ODI D: DIN: 30-02649/90-02 DPN: DRN:

~ DOCKET NO: 03002649 F I CHE: 53947 2S9 53947 260 RIDS:

9006130469 Forwards Enforcement Conference Repts 30-02649/90-03 & ,

30-00394/Y0-03 on 900502.

FROM: NORELIUS,C E. Region 3 (Post 820201) ,

TO: LOOP,F. Cleveland Clinic Foundation. Cleveland, CN4 ISSUED. 900523 AVAIL: PDP 1p- DOCUMENT TYPE: CLOUT FPAC; 9006130469*

TASK: ODID: EA-90-074 DIN: 900523 DPN: DRN:

DOCHET NO. 03002649 03000394 FICHE. 54167 337 34167 360 RIDS: IE46D 9006130474 Enforcement Conf er enc e Rep tt 30-02649/90-03 L 30-00394/90-03 on 900SO2. Major areas discusred NRC concern re apperent lack of=cooperat2on & communications between Cleveland Clinic ;

Radiation Therapy-Dept b Radiation Gafety Ofc.

FROM: MATSON E.R. Region 3 (Pott 820201) 7 TO:

ISSUED: 900523 AVAIL- PDR 3pp DOCUMENT TYPE: T11NSP FPAC: 9006130469A.

TASK; ODID 30-00394/90-03 DIN, 30-02649/90-03 DPN: EC DRN:

DOCKET NO. 03002649 03300344 F I C HE: 34167 358 54167 360 RIDS:

9006130474 01 Enforcement Conference Repts 30-02649/90-03 4 30-00394/90-03 on 900502. Major areas discussed NRC concern re appaient lack of cooperation & c o m; nun i c a t i o n s between Cleveland Clinic Radiation Therapy Dept & Radiation Safety Ofc.

FROM. MATSON,E.R. Hegton-3 (Po$t 820201)

TO:

1 SSUED: 900523 AVAIL: PDR 3pp. DOCUMENT TYPE: TIINSP.FPAC: 9006130469A >

. TASK' ODI D: EA-40-074 DIN: 30-02649/90-03 DPN: - EC DRN:

DOCKET NO: 03002649 FICHE: S4167 300 S4167 360. R IDS:

900907020S Application for amend to License 34-OO466-01 authoriring-change in c ommi t i ee memtier chip for J McCall replacsng S U1 reich as nursing representative FROM: ' ARON,5 J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 900604 AVAIL: PDR 4pp. DOCUMENT TYPE: TLAMDL FPAC: 9009070204A TASK; _

ODID: . DIN: AMBL-900604 DPN: DRN:

DOCKET NO: 03002649 FICHE: 3513S:223 3513S 22G RIDS: '

-i w,---,,,-,wv--+--n-.w-.,,- ,-n~,-,,e -,n,..v-,w,e- w. -,.,-,--,_.,,-.--~.--.m.--

U/20/92 PAGE 19 U. G. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9006270207 Forwards insp Hepts 30-00394/90-01 & 30-02649/90-01 on 900307-09 & 14-16 L notice of violation & proposed imposition of civil penalty in amount of $ 6, 87 5.

FROM: DAVIS,A.D. Regaon 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundations Cleveland, OH ISSUED: 900621 AVAIL: PDR Spp. DOCUMENT TYPE: CLOUT FPAC: 9006270207e TASK: ODID: EA-90-074 DIN: 900621 DPN: DRN; DOCKET NO: 03000394 03002649 FICHE: 54342 123 54342 101 RI DS: IEO7D 4006270287 XA Forwards Ins 9 Repts 30-00394/90-01 & 30-02649/90-01 on 900307-09 6 14-16 & notice of violation & proposed imposition of civil penalty in amount of $6,875.

FROM: DAV13,A.D. Region 3 (Post B20201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 900621 AYAIL: PDR 4pp. DOCUMENT TYPE: CLOUT FPAC: 9203060423A TASK: ODID: EA-90-074 DIN: 900621 DPN: DRN:

DOCKET NO- 03000394 03002649 F ICHE: 60899 102 60099 118 RIDS:

9006270294 Notice of violation & proposed imposition of civil penalty from insp on 900307-09 E 14-16. Violations noted: failure to notify NRC of therapy misadministration within required 24 h

& survey instrument not calibt from 198G-1990.

FROM: DAVIS,A D. Region 3 (Post G20201)

TO:

ISSUED; 900621 AVAIL: PDF 3pp. DOCUMENT TYPE: T!NVID FPAC. 9006270287A TASK: OD I D . EA-90-074 DIN. NVID-900621 DPN: DRN:

DOCKET NO, 03000394 03002649 FICHE: -04342 12G 54342 181 RIDS:

9006270294 XA Not2ce of v2olatiun & ptoposed imposition of civil penalty .

from intp on 900307-09 L 14-16. Violations noted. Failure to notify NRC of thernpy mitndmin2stration within required 24 h 34 survey instrument not calibi from 1980-1990. ,

FROM: DAVIS,A.D. Reg 2on 3 (Post 820201)

TO:

ISSUED: 900e21 AVAIL. PDR 3pp. DOCUMENT TYPE: TINVID FPAC: 9203060423A TASK; ODID: EA-90-074 DIN: NVID-900621- DPN: DRN:

DOCKET NO: 03000394 03002649 FICHE: 60899 106 60899 118 RIDS:

-9009070199 Submits action plan for GA program of dept of' radiation therapy,as promised during licensee 900502 visit to NRC.

Entire OA program will be reviewed semiannually by ofc of quality mgt.

FRCM:- KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: MALLETT,B.S. Region 3 (Post 820201) _ .

- ISSUED: 900625 AVAIL: PDR Opp. DOCUMENT TYPE: CLINC FPAC: 9009070199 TASK: OD I D. DIN: 900625 DPN: DRN!

DOCKET NO: 03002649 F1CHE: 55132 353 55132 355 RIDS: IEO7D

_ _ _ _ _ _ _ _ _ . _ _ _ . _ _ _ _ _ _ - - ._._. _ _ _.-~. _ _ _ _.. -

l O/20/92 PAGE 20 U. Sc NUCLEAR REGULATORY COMMISSION i

DCS PARTIAL RECORD FORMAT REPORT l l

9206160341 Forwards Region Ill insp rept in response to 890105 request for info re allegation NIII-89-A-OOO1.

FROM: FUNK,0.E. Region 3 (Post 820201)

-TO: PAWLIK,E.T. Region 3 (Post B20201)

ISSUED: 900625 AVAIL: PDR 1p. DOCUMENT TYPE: CMMEMO FPAC: 9206100321A TASK: ODID: DIN: 900625 DPN: DRN:

DOCKET NO: 03002649 03000394 03014577 FICHE: 62105 032 62105 072 RIDS:

4 9206180341 01 Forwards Region III insp rept in response to 090105 request for info re allegation R111-09-A-OOO1.

FROM: FUNK,D.E. Region 3 (Post 820201) 1 TO: PAWLIK,E.T. Region 3 (Post B20201)

ISSUED: 900625 AVAIL: PDR 1 p. DOCUMENT TYPE: CMMEMO FPAC: 9206100321A T ASK: ODID. DIN- 900625 DPN: DRN:

DOCKET NO: 03002649 FICHE. 62105 032 62105 072 RIDS: ,

r/OO7260020 Responds to NRC 900621 notice of violation te insp of Licenses 34-00466-01 & 34-00466-02 t. forwards paJment of civil penalty.

FROM: LOOP.F=D. Cleveland Clinic Foundetion, Cleveland, OH TO: Orc of Enforcement (Post G70413)

ISSUED: 900719 AVAIL: PDR 4pp. DOCUMENT TYPE: CLINC FPAC: 9007260020 TASK: ODID: EA-90-074 DIN: 900719 DPN: DRN:

DOCKET NO- 03002649 03000394 FICHE- 54722 314 54722 317 RIDS: IEO7D ,

9009070204 Responds to radiation safety insp findings in NRC 900522 Itr. Corrective ac tions: nuclear medicine policy re possible misadministration revised, FROM: ARON S.J Cleveland Clinic Foundation, Cleveland, OH TO: PANKRATZ,R.M. Region 3 (Post G20201)

ISSUED' 900719 AVAIL: PDR 12pp. DOCUMENT TYPE' CLINC FPAC: 9009070204*

TASK: ODID: DIN: 900719 DPN: DRN:

DOCKET NO. 03002649 FICHE: 55135 213 S$135 228 RIDS: IEO7D

90103OO15e Matls licensing package for Amend 45 to License 34-00466-01 for Cleveland Clinic Foundation. Control: 309597.

FROM: .FRAZIER,C.F; Region 3 (Post 820201F TO:

ISSUED; 900725 AVAIL: PDR 7pp. DOCUMENT TYPE: TLLMBL FPAC: '9010300156 TASK: ODID: 389597 . DIN: 34-00466-01 DPN: .A45 DRN: .

DOCKET NO: 03002649 FICHE: 55538 084 55538 090-RIDS: ML30D

__ _ -. _ ..s ,._._ _ _ __..__ ._. _ , _ _ ___._ _ _ - . _ . - _ . _ _ _ _--.m.__. .-

.0/20/92 PAGE 21 U. B. NUCLEAR REGULA~ORY COMMISSION DCS PART!AL HECORD FORMAT REPORT 9207230127 Informs of 900821 misadministration of radiophat.s Patient given 1 mci Tc-99m sulfor colloid instead of S mci Tc-99m disofenin Caused by personnel misunderstanding physicians request. Personnel reprimanded.

FROM: AROfl, S. J. Cleveland Clinic Foundation. Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 900823 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 92071SO108A TASK: ODI D: DIN: 900823-01 DPN: DRN:

DOCKET NO: 03002649 IICHE: 62546 051 62S46 052 RIDS:

.9207230127 01 Informs of 900821 misadministration of todiopharm. Patient -

given 1 mci Tc-99m sulfor colloid instead of S mC1 Tc-99m disofenin Caused by personnel misunderstanding physicions request. Personnel reprimanded.

FROM: ARON,S J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 900t&3 AVAIL PDR 2pp DOCUMENT TYPE CLINC F P AC : 92071SO100A TASK: ODI D' DIN: 900823-01 DPN: DRN:

DDCKET NO 03002649 FICHE 62S46 051 62546 052 RIDS

9012030000 Forwards addl info se action plan for GA program.per 900625 Itr FROM: KEYS.1, F. Cleveland Clinic Foundatson, Cleveland, OH TO: MATSON,E.R. Region 3 (Post 020201)

ISSUED: 900928 AVAIL PDR 1p. DOCUMENT TYPE: CLINC FPAC: 901203OO70A TASK: OD l D' DIN. 900928 DPN DRN:

DOCKET NO 03002649 03000394 F I CHE; S5999 1S1 55989 154 RIDS: _

9101080261 Matis 12 censing package for Amend 46 to License 34-00466-01 for Cleveland Clinic Fountia t i on C ont r ol: 309951.

FROM: PELKE,P.J Pegion 3 (Port 820201)

- TO; ISSUED: 901114 AVAI L :. PDR 26pp. DOCUMENT TYPE: TLLMDL FPAC: 9101080261 TASK: ODID- 389951 DIN: 34-00466-01 DPN: A46 DRN:

DOCKET NO: 03002649 F1CHE: S6348 117 S6348 142 HIDS: ML30D 9207230133 Informs of 901109 misadministration of radiopharm. Patient injected w/10.3 mC1 Tc-99m DTPA. Caused by p e t< s o n n e l error.

FRCM; ARON.S J. Cleveland Citnic Foundation, Cleveland, OH TO: MATSON,E. Region 3'(Post 820201)

I SSUED : 901119 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 92071SO108A

-TASK: ODID: DIN: 901119-01 DPN: DRN:

DOCMET NO: 03002649 FICHE: 62546 033 62546 OS4 RIDS:

l G/20/92 PAGE 22 U Si . NUCLEAR REGULATORY' COMMISSION DCS' PARTIAL-RECORD _ FORMAT REPORT-9207230133 01 Informs of 901109 mitadministration of radiopharm. Patient injected w/10.3-mC1 Tc-99m DTPA. Caused by-personnel error.

FROM: ARON,S.d Cleveland Clinic Foundation. Cleveland, OH 70; MATSON,E. Region 3 (Post 820201)

ISSUED: 901119 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 92071SO10BAL TASX: ODID: DIN: 901119-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62346 053 62546 OS4 RIDS:

9012030078 Discusses 900302 enforcement conference w/ staff to discuss licensee plans to improve apparent communications problem.

TROM: DAVIS,A.D. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 901126 AVAIL; PDR 1p. DOCUMENT TYPE: CLOUT FFAC: 9012030078*

-TASK: ODID: DIN: 901126 DPN: .DRN:

COCMET NO: 03CO2649 03000394 FICHE: 55984 ISO SS989 IS4 RIDS: IEO7D-9102070420 Voided matis licensing action for License 34-00466-01 for Cleveland Clin F ound a t i on. Contr o l: 3?O247.

FROM:

Region-3 (Post 820201)

TO: NRC - No Detailed'Aff111ation Given ISSUED. 901220 AVAIL: PDR 4pp. DOCUMENT TYPE. CMMEMO FPAC: 9102070420 TASK: ODID: 390247 DIN: 901220 -DPN: DRN:

DOCKET NO. 03002649 FICHE: 56620 277 56620 280 RIDS: ML30D 9102070440 Matls licensing package for Amend 47 to License 34-00466-01 for Cleveland Clinic Foun da ti on. Contr ol: 390604.

FROM: - PELKE> P. J. Region 3 (Post 820201)

T O:.

ISSUED: 901220 AVAIL: PDR 6pp. DOCUMENT TYPE: TLLMBL FPAC: -9102070440<

T ASK: ODID: 390604 DIN: 34-00466-01 DPN: A47 DRN: '

DOCKET ND: 03002649 F ICHE: 56620 267 S6620 272 RIDS: ML30D 9103060335 Responds to NRC 901130 Itr te allegation.of improper-care at Cleveland Clinic Hosp. Suggests that complaint be referred to Ohio State Medical Doard.

FROM: BENNETT,C.F. Health 5 Human Services, Dept of.

.TO: NORELIUS,C.E. Reglon-3 (Post 820201)

ISSUED: 901220 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9103060333-TASK: .

DDID: _ DIN: 901220 .DPN: .

DRN:

DOCKET NO: 03002649 F.ICHE: 56904 062 S6904 063 RIDS: -IEO7D-i

... - -. ..-.~ . - - . . - - . . . _ - - ~ _ . - - - . _ . . . ~ _ -. , ~ . - _ _ . . . .

B/20/92- PAGE. 2T U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9103150049 Matls licensing package for c or.r e c t e d Amend 47-to License 34-00466-01 for Cleveland Clinic _ Foundation. j FROM: PELKE,P.J. Region 3 (Post 820201)

TO:

ISSUED: -910211 AVAIL: PDR 3pp. DOCUMENT TYPE: TLLMDL FPAC: 9103150049 YASK: ODID: DIN: 34-00466-01 DPN: A47 DRN: -Ol' ;

DOCKET NO: 03002649_ FICHE: S7050 326 S7050 328 RIDS: -ML300 ;

-9207230144 Informs of 910211 misadministration of radiopharm Patient

-given 015 mci INal-131 instead of 10 mC1 INa!-131. Imaging Technologist misunderstood physicians request. Signed-worksheet will be attached to pick isotope request.

FROM: ARON.S J- Cleveland Clinit Foundation. Cleveland, OH TO: Region 3 (Post 820201)

- I SSUED: 910218 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 92071SO108A

. T ASK: ODID: DIN: 91021G-01 DPN: DRN:

. DOCKET NO: 03002649. FICHE: 62546 055 62546 OS6 RIDS:

9207230141 01 Informs.cf 910211 misadministration of radiopharm. Patient given 015 mci INal-131 instead of 10 mci INaI-131. Imaging Technologist misunderstood physicians request. Signed worksheet will be attached to pich 1sotope t' e qu e s t.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 020201)

ISSUED. 910218 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: '92071SO108A TASK: ODID: DIN: .910218-01 DPN: DRN:

DOCKET NO: 03002649 . FICHE- 62546 OSS 62546 OS6c RIDS:

9207230204 Informs of 910412 misadministration of rad 2cpharm. Employee received estremity exposure during 1st quarter of~1991.

Caused by use of position emitting radioisotopes for care

-of nuclear medicine patients.

FROM: ARON S=J, Cleveland Clinic Foundation, Cleveland, OH' TO: SIMMONS.T. Region 3 (Port 820201)

I SSUED: 910415 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPACi 92071SO10BA T ASK: ODID: DIN: 910415-01 DPN: DRN:

DOCKET NO: 03002649 F ICHE: 62546 057 62546 OSB RIDS:

i9207230'204 01 Informs of 910412 misadministration of radiopharmcEmployee received entremity exposure during ist quarter of:1991.

Faused by use of position emitting radioisotopes for care oof_ nuclear _ medicine patients.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: SIMMONS,T. Regton_3_TPost 820201)

ISSUED: 910415 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 92071SO10GA TASK! ODID: DIN: 910415-01 .DPN: DRN:

DOCKET NO:. 03002649 FICHE: 62346 057 62346 050 RIDS:

i w ..;-.

. . + +. , _ - , , , , . _

m , _ . _ , ._,-,,m., . . , , . - , - # - -

8/20/92' JPAGE' 24 V S; NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9106100170 Matis licensing package for amend 48 to license 34-00466-01 for Cleveland Clinic Foundation. Control:391035.

FROM:

Region 3 (Post 820201)-

5 TO:

ISSUED: 910424 AVAIL: PDR 5pp. DOCUMENT TYPE: TLLMBL FPAC: 9106100170 TASK: ODID: 39103S DIN: 34-00466-01 DPN: A4B DRN:

DOCKET NO: 03002649 FICHE: S8029 343 -58029 347 RIDS: ML30D 9105020232 PNO-III-91-019 on 910415-18, licensee reported that patient who underwent brachytherapy treatment for tracheal cancer '

received radiation dose 327. lower than perscribed.

FROM: SLAWINSKI,W. Region 3 (Post 820201)

TO:

ISSUED: 910425 AVAIL: PDR 1p- DOCUMENT TYPE: TIPNOT FPAC: 9103020232 TASK: ODID. DIN: PNO-III-91-019 DPN: DRN:

DOCKET NO: 03002649 F I C HE : 57569 199 S7569 199 RIDS: IE34D 9207230208 Informs of 910414 misadministration of radiopharm Dose miscalulatton for endobronchial application discovered.

Incorrect calculation Form put in practice in 1988. Physicist

. responsible never revised forms & left dept.

FROM: ARON,S.d Cleveland Clinic Foundation. Cleveland, OH TO: SIMMONS.T. Region 3 (Post 820201)

ISSUED: 910426 AVAIL: PDR Spp DOCUMENT TYPE: CLINC FPAC: 9207150108A TASK: ODID: DIN: 910426-01 DPN; DRN:

DOCKET NO: 03002649 FICHE- 62546 059 62546 063 R IDS:

9207230208 01 Informs of 910414 misadministration of radiopharm Dose I miscalulation for endobronchial application discovered.

Incorrect calculation form put in practice in 1988. Physicist g responsible never revised forms & left depti Cleveland Clinic Foundation, . Cleveland, OH.

FROM: ARON,S.J TO: SIMMONS.T. Region 3_(Post 820201)

I SSt 'ED - 910426 AVAIL: PDR "pp. DOCUMENT -TYPE: CLINC FPAC: 9207150108A TASR: OD I D: DIN: 910426-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62546 OS9 62346 063 RIDS; 9105300030 FNO-I I I-91-021 : o n 910516. evidence ~ found of radioactive contamination. Caused by leaving P-32 valve All areas contaminated were decontaminated or restricted to allow-d ec a y .- Fur th er evaluations of contamination-pending.

FROM: SCHULTZ,W, Region 3.(Fost 820201) _

-TO:

ISSUED: 910520' AVAIL: PDR ~2pp. DOCUMENT TYPE: TIPNOT FPAC: 9105300030 TASK: ODID: DINi PNO-III-91-021- DPN: DRN:

DOCKET NO: 03002649 FICHE: 57865-320 S7865 321 RIDS: IE34D

w ,

_ s e a2# mn wammfo .g 8/20/92 PAGE 25 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9105300050 Confirmatory of action 1tr te 910520 telcons concerning activities following discovery of contamination event involving Ph-32 that 'ccurred on 910516.

' FROM: DAVIS A.B. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ,

I SSUED: 910521 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT ~FPAC: 9105300050 TASK: ODID' CAL-RIII-04 DIN: 910521 DPN: - DRN:

DOCKET NO: 03002649 F ICHE : 57871 061 S7871 062 RIDS: IEO7D_

9105300050 XA Confirmatory of action ltr re 910S20 telcons concerning activities following discovery of contamination event involving Ph-32 that occurred on 910516.

FROM: DAVIS,A.D. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 910S21 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9203060423A TASK: ODID. CAL-HIII-04 DIN: 910S21 D P N :- DRft:

DOCKET NO 03002649 FICHE: 60899 007 60899 000 RIDS:

9105310041 PNO-III-91-021A on 910521, progress - of licensee investigation of P-32 event on 910S16 evaluated Individuals who had small amounts of contamination on hands & faces, decontaminated.

FROM: SCHULTZ, W. Region 3 (Post 320201)

TO:

ISSUED 1 910524 AVAIL: PDR 1r DOCUMENT TYPE: TIPNOT FPAC: 9105310041 TASK: ODID. DIN: PND-III-91-021A DPN; DRN; DOCKET NO: 03002649 FICHE: 57873 169 S7873 169 RIDS: IE34D 9106140190 Revised Confirmatton of Action Ltr CAL-RIII-04A.

Understands that licensee will not use licensed matis in Lab L NC1-140 until listed actions taken,per 910505- telcon.

FROM; - DAVIS, A. B. Region 3 (P os t 820201 ) . _

TO: LOOP,F. Cleveland Clinit Foundation, Cleveland, OH ISSUED: 910606 AVAIL: PDR 1p- DnCUMENT TYPE: CLOUT FPAC: 9106140190 TASK: ODID: CAL-RIII-04A DIN: 910606 DPN: DRN:

DOCKET NO: 03002649 F I CHE : 58328 102 38128 102 RIDS: IE36D I 9106140190 XA Revised C on f i rma t t o r. of Action-Ltr! CAL-RIII-04A.

Understands'that licensee will-not use Itcensed matis in Lab NC1-140 until listed actions taken,per_ 910605 telcon.

l - -

FROM: DAVIS,A D. Region 3 (Post 820201)

TO: LOOP,F. CIeveland Clinic Foundation, Cleveland, OH ISSUED: 910606 AVAIL: PDR 1 p. DOCUMENT TYPE: CLOUT FPAC: 9203060423A TASK: ODID: CAL-RIII-04A DI N:- 910606 DPN; DRN:

o DOCKET NO: 03002649- FICHE: 60899 O23 - 60899 023 RIDSL i

l-1

. . . _ - - . . . _ . - - _ , ,, _ _ , - - - _ m , -,

O/20/92 PAGE 26 U. S; NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT

-9107080220 Responds to confirmatory action Itr of 910521. Corrective actions: all new members of all labs using radioisotopes will be instructed in proper handling & use of mat 15-& proper response in case of rad 2oactive spill.

FROM: ARON S J. Cleveland-Clinic Foundation, Cleveland, OH TO: DAVIS,A B. Region 3 (Post 820201)

ISSUED: 910612 AVAIL: PDR 11pp. DOCUMENT TYPE: CLINC FPAC: 9107080204B-TASK: ODI D- CAL DIN: 910612 DPN: DRN:

DOCKET NO: 03002649 FICHE: 58389 204 58389 214 RIDS:

9107080220 XA Responds to confirmatory action ltr of 910521. Corrective actions:all new members of all labs.using radioisotopes will_

be instructed in proper handling & use of matis & proper response in case of radioactive spill.

FROM: ARON.S J. Cleveland Clinic Foundation, Cleveland OH TO: DAVIS,A.D. Region 3 (Post 820201)

ISSUED: 910612 AVAIL: POR lipp. DOCUMENT TYPE: CLINC FPAC: 9203060423A TASK: ODID: CAL DIN; 910612 DPN: DRN:

DOCKET NO: 03002649 FICHE: 60899 009 60899 019 RIDS:

9107080215 Addresses specific issues re use of rt !oactive matis in lab of PL Fox concerning confirmatory action 1tr dtd 910521.

FROM: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH

, T O_:

DAVIS,A.D. Region 3-(Post 820201)

ISSUED: 910620 AVAIL. PDR 3pp DOCUMENT TYPE; CLINC FPAC: 9107080204A TASK: ODID; CAL DIN: 910620 DPN: -DRN:

DOCKE T NO. 03002649 F I CHE: 58389 201 58389 203 RIDS:

9107000215 XA Addresses specific issues te use of-vadioactive.matis in lab of PL For concerning c o n f irma'.o r y action 1tr dtd 910521.

FROM: KEYS,T F. Cleveland Clinic Foundation, Cleveland, OH TO: DAVIS,A.B. Region 3 (Post 820201)

ISSUED: 910620 AVAIL: PDR 3pp, DOCUMENT TYPE: CLINC FPAC: 9203060423A.

TASK: DDID' CAL DIN: 910620' DPN: DRN:

DOCKET NO. 03002649 FICHE; 60899 020 60899 022 RIDS:

9107090204 Informs that completion of tasks-b submission of results re 910516 investigation of contamination event, corrective actions to prevent recurrence & results_of--personnel-exposure evaluations satisfy requirements.

FROM: DAVIS,A.B. Region _3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 910628 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9107080204*

TASK: ODID: EA-91-OB4 DIN: 910628 DPN: DRN:

DOCKET NO: 03002649 FICHE: 58389 200 58389 214 RIDS: IEO7D

_ . m ._m... _. . __ , ~__ ~_=_ . .

._m ._ . _ ___ _. ___ ._ _.

8/20/92' PAGE 27 U. S.' NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT

-9107080204 XA Informs that completion of tasks & submission of results re 910516 investigation of contamination event. corrective actions to prevent recurrence h results of personnel exposure evaluations satisfy requirements.

FROM: DAVIS,A.D. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation. Cleveland, OH-I SSUED: 910628 AVAIL: PDR 1 p. DOCUMENT TYPE: CLOUT FPAC: 910918023SA TASK: ODID: EA-91-084 DIN: 910628 DPN: DRN:

DOCKET NO. 03002649 FICHE: 59261 140. 59261 140 RIDS:

9107050236 Notification of 910715 meeting in Glen Ellyn,IL to discuss NRC findings during recent contamination event response &

routine insp,NRC enforcement policy & licensee corrective actions.

FROM; GROGE,J.A. Region 3 (Post 820201)

TO: Region 3 (Post 820201)

ISSUED. 910702 AVAIL: PDR 2pp. DOCUMENT TYPE: CMMEMO FPAC: 9107030236 TASK: ODID. EA-91-084 DIN: 910702 DPN: DRN:

DOCKET NO: 03002649 FICHE. 58388 170 58388 171 RIDS: IEO7D 9107050236 XA Notification of 910715 meeting.In Glen Ellyn,-IL to discuss NRC findings during recent contamination event response &

-routine insp,NRC enforcement policy L licensee corrective actions.

FROM. GROBE,J A. Region 3 (Post 820201)

TO: Region 3 (Post 820201)

ISSUED' 910702 AVAIL: PDR 2pp. DOCUMENT TYPE: CMMEMO FPAC: 910918023SA TASK: OD I D. EA-91-084 DIN: 910702 DPN: DRN:

DOCKET NO: 03002649 FICHE: 59261 141 59261 142 RIDS; J-91071603S4 Insp rept 30-02669/91-01 on 910518-0618. Violations noted.

Major areas inspected: events te Apr 1991 therapy misadministration 6 910516 spill of P-32 resulting in onsite & offsite contamination.

FROM: CAMERON,J.L. Region 3 (Post 820201)

TO:

ISSUED: 910710 AVAIL: PDR 22pp. DOCUMENT TYPE: TIINSP FPAC: 9107160345A

. TASK; ODID: DIN: 30-02649/91-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: S8421-093 S8421 114 RIDS:

9107160334 XA Insp rept 30-02649/91-01 on 910518-0618. Violations noted.

Major areas inspected: events re Apr 1991 therapy misadministration L 910S16 spill of P-32 resulting in onsite & offsite contamination.

FROM: CAMERON.J.L. Region 3 (Post 820201) 10:

I SSUED: 910710 AVAIL 1 PDR 22pp. DOCUMENT TYPE: TIINSP FPAC: =910918023SA-TASK: ODID: DIN: 02649/91-01 DPN: DRN:

DOCKET'NO: 03002649 FICHE: 59261 145 S9261 172 RIDS:

8/20/92 PAGE 2G U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9107160345 Forwards insp rept 30-02649/91-01 on 910510-0618. Violations noted & being considered for escalated enforcement action.

FROM: NORELIUS,C.E Region 3 (Post 820201)

TO: LOOP,F. Cleveland C)inic Foundation, Cleveland, OH ISSUED: 910711 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9107160345*

TASK: ODID: EA-91-084 DIN: 910711 DP N : DRN:

DOCKET NO: 03002649 FICHE: 58421 091 58421 114 RIDS: IEO7D 9107160345 XA Forwardt insp rept 30-02649/91-01 on 910318-0618. Violations noted L being considered for escalated enforcement action -

FROM: NORELIUS,C.E. Region 3 (Post 820201)

TO: LOOP. F Cleveland Clinit Foundstion, Cleveland, OH ISSUED' 910711 AVAIL PDR 2pp. DOCUMENT TYPE: CLOUT F P AC : 9109180235A TASK ODID EA-91-OE4 DIN: 910711 DPN. DRN:

DOCKET NO 03002649 FICHE 59261 143 59261 172 RIDS.

910U020020 Enforcement Conference Rept 30-02649/91-02 on 910715 Major areas d1scussed: ftndings from 910518-0616 insp re accuracy of facts,c:wial factors, corrective E tions taken or planned by Itcens+e & NRC e n f o t-c o m e n t policy FROM. C AMERO% J L. Region 3 (Post 620201)

TO:

ISSUED 910723 AVAIL PDR 30pp DOCUMENT TYPE. TIINSP FPAC. 910802OO1GA TASK: ODID' DIN- 30-02649/91-02 DPN: EC DRN:

DOCHET NO: 03002649 FLCHE. 58635 205 58635 243 RIDS:

9108020020 XA Enforcement Conference Pept 30-02649/91-02 on 910715 Major -

areas discusred' findings from 91051F-061G Insp re accuracy of facts, causal factors, corrective actions taken or planned by licensee L NRC enforcement policy FROM: CAMERON.J L. Region 3 (Post 820201)

TO:

ISSUED 710723 AVAIL PDR 39pp DOCUMENT TYPE TIINSP FPAC: 91091BO235A TASK: ODID: DIN: 30-02649/91-02 DPN: EC DRN:

DOCKET NO. 03002649 F I CHE : 59261 192 59261 229 RIDS:

910731024T EN 042 : o n c10729, notice of violation & proposed imposition of civil penalty in amount of 57,500 will be issued te Goverity Level III problems w/ radiation safety program Fenalty escalated 2007.

FROM'. P EDER SON, C. D. Region 3 (Post 820201)

TO.

ISSUED: 910724 AVAIL: PDR 2pp. DOCUMENT TYPE: TIEN FPAC: 9107310242 TASK: ODID. DIN: EN-91-042 DPN: DRN:

DOCKET NO. 03002649 FICHE: 58622 332 58622 333 RIDS: IE33D

. . . ~,- - . ~ . . . . . . . . . _ . - - , - . - ~ . . . - . -

8/20/92 PAGE 29 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9108020018 Forwards Enforcement Conference Rept 30-026'9/91-02 4 on 910715 re apparent violations & concerns noted.during 910518-0618 insp. Decision te enforcement action will be sent via separate correspondence; FROM: NORELIUS,C.E. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 910725 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9108020018*

TASK: ODID: EA-91-084 DIN: 910725 DPN; DRN:

DOCKET NO: 03002649 FICHE. 38635 204 58635 243 RIDS: IEO7D

-9108020018 XA Forwards Enforcement Conference Rept 30-02649/91-02 on 910715 re apparent violations L concerns noted during 910518-0618 insp. Decision re enforcement action will be sent via separate correspondence.

FROM: NORELIUS,C.E. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleve'ind, OH ISSUED: 910725 AVAIL: PDR 1p. DOCUMENT TYPE: CLOT FPAC: 9109180235A T ASK: OD I D. EA-91-084 DIN: 910725 DPN: DRN:

DOCKET NO: 03002649 FICHE: 59261 191 59261 229 RIDS:

9108050013 Discusses insp rept 30-02469/91-01 & forwards notice of

. violation L proposed imposition of civil penalty _

FROM: DAVIS.A B. Region 3-(Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 910729 AVAIL: PDR Sp p. DOCUMENT TYPE: CLOUT TPAC: 9108050013*

TASK: ODID- EA-91-084 DIN: 910729 DPN: DRN:

DOCKET NO: 03002649 FICHE: 58634 030 58634 041 RIDS: IE14D 9108050017 Notice of violation A proposed imposition.o;f civil penalty in amount of 57,500 Noncompliance noted. failure to make surveys to assure comp 11 ante w/10CFR20.101 re redsation exposure to e x t r emi t i e s. L tkin.

FROM; DAVIS,A.D. Region 3 (Post 820201)

TO:

ISSUED. 910729 AVAIL: FDR 6ppz DOCUMENT . TYPE: TINVID FPAC: -9108050013A TASK: ODID: EA-91-084 DIN: NVID-910729 DPN: DRN:

DOCKET NO. 03002649 FICHE: 58634 035' 58634 041 RIDS:

9108050017 XA Notice of violation & proposed imposition of civil penalty in amount of $7, 500. Nonc omp l ianc e no ted : f ai lure to make surveys to' assure compliance w/10CFR20.101 re-radiation euposure-to extremities & skin.

FROM: DAVIS,A.B. Region 3 (Post 820201)

TO:

ISSUED: 910729 AVAIL: POR 6pp. DOCUMENT TYPE:. TINVID-rPAC: 9109180235A

' TASK: ODID: EA-91-084 DIN: NVID-910729 DPN: DRN:

DOCKET NO: 03002649 FICHE: 59261.17'3 59261 190 RIDS:

___ g 8/20/92 PAGE- 30 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9207230231 Informs of 910727 masadministration of radiopharm. Patient given 30 mci Tc-99m PYP for. lung vent study i nstead of 30 mci DTPA. Reconstituted wrong. reagent-kit, Implemented.new procedures for labeling & handling.

FROM:

Cleveland Clinic Foundation, Cleveland, OH

- TO: Region 3 (Post 820201)

ISSUED: 910729 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 0207150108A TASK: ODID: DIN: 910729-02 DPN: DRN:

DOCKET NO; 03002649 FICHE: 62546 065 62546 065 RIDS:

9207230231 01 Informs of 910727 misadministration of radiopharm. Patient given 30 mC1.Tc-99m PYP for lung vent study instead of 30 mci DTPA. Reconstituted wrong-reagent bit Implemented new.

procedures for labeling b handling.

FROM:

Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 910729 AVAIL: PDR 1p, DOCUMENT TYPE: CLINC FPAC: 92071SO108A TASK: ODID: DIN; 910729-02 DPN: DRN:

DOCKET NO. 03002649 FICHE: 62546 065 62546 065 RIDS:

9207230257 Informs of 910728 masadministration of radiopharm Patient given 30 mci Tc-99m PYP for lung vent study i nstead of 30 mci DTPA Reconstitued wrong reagent kit Implemented new procedures for labeling 6 handling FROM:

Cleveland Clinic Foundation

Cleveland, OH TO: Region 3 (Post 820201)

I SSUED.: 910729 AVAIL: PDR 1p- DDCUMENT TYPE: CLINC FFAC: 9207130108A '

TASK: ODID' DIN: 910729-03 DPN: DRN:

DOCKET NO. 03002649 F1CHE' 62546 066 62546 066 RIDS:

92072302S7 01 Informs of 910728 misadministration of radiopharm. Patient given 30 mC1 Tc-99m PYP for lung vent study i nstead of 30 mC1-DTPA.Reconstitued wrong reagent Ftt. Implemented net procedures For labeling b handling.

FROM:

Cleveland Clinic Foundation, Cleveland,-OH TO: Region 3 (Post 820201)

ISSUED: 910729 AVAIL: PDR 1p. DOCUf1ENT TY P E-: CLINC- FPAC; 9207150108A' TASK: ODID: DIN; 910729-03 DPN: DRN:

DOCKET NO. 03002649 FICHE: 62546 066 62546- 066 RIDS:

9207230215 Forwards two repts of misadministration of-radiopharms on 910727 L 28.

FROM: SAHA.O Cleveland Clinic Foundation; Cleveland. OH TO: Region'3 (Post 820201).

ISSUED: 910731 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 9207100108A TASK: ODID: DIN: 910731-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62546 064 62546 064 ' RIDS:

e y.y -- - -.---,.-,,-_.--,4-+v e n... = , , , , , , , . . , , , w r iv v'

.8/RO/92 PAGE 31 U. S.-NUCLEAR REGULATORY COMMISSION DCS. PARTIAL-RECORD FORMAT REPORT 9207230215-01 Forwards two repts of misadministration of radiopharms on 910727 L 28.

-FROM: SAHA,G. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 910731 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC, FP AC: 92071SO108A TASK: ODID: DIN: 910731-01 DP N: DRN:

DOCKET NO: 03002649 FICHE: 62S46 064. 62346 064 RIDS:

9109000328 Forwards interim radiation safety plan & requests extension of current broad license to completely rewrite license.

FROM: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: GROBE.J. Region 3 (Post 820201)

- I SSUED: 910816 AVAIL: PDR 4pp. DOCUMENT TYPE- CLINC FPAC: 9109030328 TASK: ODID: D1N: .910916 DPN: DRN:

DOCKET.NO. 03002649 - F ICHE: 59029 17S 59029 178 RIDS: IEO7Dt 9109190115 Matls licensing pac kage f or amend 44 to license 34-00466-01 for Cleveland Clinic Foundati on. C ont r ol: 39.1626.

FROM: MCCANN,G.M. Region 3 (Post 820201)

TO:

I SSUED: 910822 AVAIL: PDR 8pp. DOCUMENT TYPE: TLLMDL FPAC: 9109190115 TASK: ODI D: 391626 DIN. 34-00466-01 DPN: A49 DRN

. DOCKET NO- 03002649 FICHE: S9209 354 59208 361 RIDS: ML30D

-9109030131 Responds to notice of violation.dtd. 910729 re: License-34-OO466-01. Corrective actions:research workers. instructed to perform personal & area survey 5- to evaluate suspected exposure.

FROM: LOOP,F.D. Cleveland-Clinte Foundation, Cleveland. OH-TO: Ofc of Enforcement (Post 870413) ~

ISSUED: 910829 AVAIL: PDR 17pp. DOCUMENT TYPE: CLINC FPAC: 9109050131-TASK: ODID: EA-91-OG4- DIN: 910829' DPN: DRN:

DOCKET NO: 03002649 F I C HE : 59171-222 S9171 238 RIDS: IE14D 19A09110024 Notification-of:significant licensee meeting on 910910-to discuss NRC' concerns / comments L items of mutual interest te licensee reorganization of tsdiation safety program FROM: GROBE,J.A. Region-3 (PostJ820201)

TO: Region 3 (Post 820201)

ISSUED: 910905 AVAIL: .PDR . 2pp. DOCUMENT TYPE: CMMEMO-FPAC: 9109110024-

' TASK: ODID: EA-91-OB4 DIN: 910905 DPN: DRN:

DOCKET NO: 03002649 ' FICHE: 390S3 200 59053 201 RIDS: IEO7D

._._ . , _, . _ _ _- -_ _ _ 2. ._ _ _ _ u. . - .

8/20/92' ? AGE 32 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT '

-91A1080212 Matis licensing package for corrected amend 49 to license 34-00466-01 For Cleveland Clinic Foundation.

FROM: NULL.K.G. Region 3 (Post 820201)

TO:

I SSUED: 910906 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 9111080212 TASK: ODID: DIN: 34-00466-01 DPN: A49 DRN: 01 DOCKET NO: 03002649 FICHE: 59706 250 59706 251 R I DS: ML30D 9111120346 Matls licensing package for amend 50 to license 34-00466-01 for Cleveland Clinic Foundation. Control: 391883, FROM: FRAZIER C.L Region 3 (Post 820201)

TO:

ISSUED: 910912 AVAIL: PDR 43pp. DOCUMENT TYPE: TLLMBL FPAC: 911112O346 TASK: ODID: 391693 DIN: 34-00466-01 DPN: ASO DRN:

DOCKET NO. 03002649 FICHE: 59701 141 S9701 183 RIDS: ML3OD 9110010281 Responds to NRC 910729 Itr te violations noted in insp of license 34-DO466-01. Corrective actions reporting requirements outlined in 10CFR20.403 will be re-emphasized &

structured course in radiation safety will be offered.

FROM: LOOP,F.D. Cleveland Clinic Foundation. Cleveland, OH TO: Document Control Branch (Document Control Desk)

ISSUED. 910924 AVAIL: PDR 4pp, DOCUMENT TYPE: CLINC FPAC: 9110010281 TASK: ODID: EA-91-OB4 DIN: 910924 DPN: DRN:

DOCKET ND 03002649 FICHE: 59263 330 S9263 333 RIDS: IE14D 9208140022 Appeals NRC 910C12 response to FOIA request for portions of 148 page record concerning 910516 spill of radioactive matl at Cleveland Clinic.

FROM: .DAV I S, D. Plain D e s.l e r , Cleveland, OH TO: Ofc of the Executive Director for Operations ISSUED: 911008 AVAIL: PDR 2pp. DOCUNENT TYPE: CLINC FPAC: 9208140022 TASK: ODID: DIN: 911008 DPN: DRN:

DOCHET NO: 03002649 FICHE. 62772 241 62772 242 RIDS:

9208140022 01 Appeals NRC 910912 response to FOIA request for portions of 148 page record concerning 910516 spill of radioactive matl at Cleveland Clinic.

FROM: DAVIS,D. Plain Dealer, Cleveland, OH TO: Oft of the Executive Director for Operations

. I SSUED: 911008 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FFAC: 9208140022 TASK: ODID. DIN: 911008 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62772 241 62772 242 RIDS:

l l

8/20/92 PAGE 33 U. G. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 911017017G Ack receipt of 910829 & 0924 ltrs & $7,500 check for payment of civil penalty proposed by N9C on 910729. Corrective actions examined during future insp_

FROM: LIEDERMAN.J. Ofc of Enforcement (Post 870413)

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 911011 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9110170178 TASK: ODID: EA-91-084 DIN: 911011 DPN: DRN:

DOCKET NO: 03002649 FICHE: S9373 043 59373 045 RIDS: IE14D 9112310026 Submits ogt astetsment of f2rst monthly rept f rom c onsul tant per comp 11 ante w/ license tendition FROM: KEYS,T,F. Cleve16nd Clinic Foundation, Cleveland, OH 70- GPODE,J Reg 2on 3 (Post 820201)

ISSUED: 911014 AVAIL: PDR 12pp. DOCUMENT TYPE: CLINC FPAC: 9112310021B TASK: ODID DJN: 911014 DPN: DRN:

DOCKET ND: 03002649 FICHE- 60130 094 60130 105 RIDS:

9112310024 Submits mgt a3se,sment of second roonthly rept in compliance w/ license condition.

FROM: KEYS,T.F. Cleveland Citntc Foundation, Cleveland, OH TO: GPOEE.J H e g i o r. 3 (Post 820201)

ISSUED. 911115 AVAIL PDR 1Epp DPCUMENT TYPE: CLINC FPAC: 9112310021A TASK: ODID. DIN: 911115-01 DPN: DRN:

DOCKET NO: 0 3 CO26A9 FICHE- 60130 076 60130 093 RIDS:

9208140010 Responds to 411000 appeal of NRC 010912 response denying portiont of 148 page record tencern2nq 910516 spill of radioactive matl at Cleveland Clinic. Informs that appeal partially granted L partially denled FROM: THOMPSON,H.L- Office of Nuc l ear Material Safety & Safeguards TO DAVIS,D Plain Dealer, Cleveland, OH I SSUE D - 91100i AVAIL PDR 2pp DOC UM Et4T TYPE: CLOUT FPAC: 9208140019*

TASK: ODID: DIN: 911206 DPN: DRN:

DOCKET NO: 03002649 F I C HE : 62772 243 62772 271 R I DS:

920G140019 01 Responds to 911008 appeal of NRC 910912 response denying portions or 148 page record concerning 410316 spill of radioactive matl at Cleveland Clinic. Informs that appeal partially granted & partially dented.

FROM: THOMPSON.H L. Office of Nuclear Material Safety & Safeguards TO: DAVIS.D. Plain Dealer, Cleveland, OH ISSUED: 911206 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9208140019*

TASK: ODID- DIN: 911206 DPN: DRN; DOCKET NO. 03002649 FICHE: 62772 243 62772 271 R IDS:

8/20/92 PAGE 34 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9201230161 Submits mgt a s.t e s s m e n t o f- third monthly rept.

FROM: KEYS,T.F. Cleveland, OH TO: GROBE,J. Region 3 (Post 820201)

ISSUED 911212 AVAIL: PDR lipp. DOCUMENT TYPE: CLINC FPAC: 9201230158A TASK: OD I D. DIN: 911212 DP N: DRN:

DOCKET NO. 03002649 F ICHE: 60348 002 60348 012 RIDS:

911231002) Ack receipt of 911014 !< 1135 Itrs submitted to show compliance w/ condition 21 of license.

FROM: GROBE,J.A. Region 3 (Post 800201)

TO: KEYS,T F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 911218 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9112310021*

TASK ODID. EA-91-OO4 DIN: 911218 DPN: DRN:

DOCKET NO 03002649 FICHE: 60130 075 60130 105 RIDS: IEO7D 9201230158 Adv1:e; that 10CFR35 32(f) requires ey1 sting licensees to submit urttten certtfication of 2mplementation of quality mgt program by 920127 FROM- GRODE.J A Region 3 (Post 820201)

TO KEYED,T F Cleveland. DH ISSUED. 920115 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 92012301585-TASK: ODID EA-91-084 DIN: 920115 DPN: DRN:

DOCKET ND 03002649 FICHE: 30348 001 60348 012 RIDS: IEO7D 9203160200 Confirms 4'20121 telephone agreement w/WH Schultz re assisting as medical consultant tc evaluate individual involved in incident described in enc 1 PNO-III-92-01.

FROM: DAVIS,A.B. Region 3 (Post 820201)

TO: MIRAcDI,F D. Univer si t y Hosps- of Clevelanc, Cleveland, OH ISSUED: 920124 AVAIL: PDR 1 p. DOCUMENT TYPE: CLOUT FPAC: 92O3160194A T ASK : OD I D; DIN. 920124 DPN: DRN:

DOCKET ND 03002649 FlCHE- 60911 325 60911 325 RIDS:

9203160230 P" quests background info on F Miraldi 6 involvement in misadministration issue which occurred in Jan 1992.

FROM: KEYES,T F. Clevaland Citnic Foundation, Cleveland, OH TO; GROBE,J Region 3 (Post 820201)

ISSUED: 920302 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 9203160194B TASK: ODID: DIN: 920302 DPN: DRN; DOCKET NO: 03002649 FICHE: 60911 326 60911 327 RIDS:

m.....

7 O/20/92 PAGE 35 U 'S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT

-9204100385 Matis itcensing package for amend Si to license 34-00466-01 for Cleveland Clinic Founda t ion. Control: 392139.

FROM: FRAZIER,C.F. Region 3 (Post 820201)

TO:

ISSUED: 920304 AVAIL: PDR 49pp. DOCUMENT TYPE. TLLMBL FPAC: 9204100385 TASK: ODTD: 392139 DIN: 34-00466-01 DPN; ASI DRN:

DOCKET NO: 03002649 FICHE: 61329 001 61329 048 RIDS: ML30D 9203160194 Advises of reevaluation of Miraldi assignment to evaluate _

misadministration that occurred at clinic on 920117.

Concludes that F Miraldi is independent b appropriately qualified to complete evaluation of medical effetts.

FROM: GRODE,J.A. Region 3 (Post 820201)

TO: KEYS,T.F. Cleveland Clinic Foundation, Clevelend, OH ISSUED: 920310 AVAIL PDR 1 p. DOCUMENT TYPE: CLOUT FPAC: 9203160194*-

TASK; ODID: DIN: 92O310 DPN: DRN; DOCKET NO: 03002649 FICHE: 60911 324 60911 327 RIDS: IEO7D 9204070026 Insp repts 30-02649/92-01 b 30-17931/92-01 on 920128-29 No violations noted. Major areas i n s p e c t e d .- 1 r r a d i a t o r s . r e c o r d s ,

brachytherapy storage room & interviews w/ personnel.

FROM: REICHHOLD.W P. Region 3 (Post 820201)

TO:

I SSUE D: 920325 AVAIL. PDR 6pp. DOCUMENT TYPE: TIINSP FPAC: 9204070016A TASK: ODID 30-17931/92-01 DIN: 30-02649/92-01 DPN: DRN:

DOCKET NO. 03002649 03017931 FICHE: 61228 159 61228 164 RIDS:

9204070016 Forwards insp repts 00-02649/92-01 & 30-17431/92-01 on' 420126-29.No violations noted. Listed areas of concern, including faded color on Cs-137 sources identified.

FROM: SCHULT2,W.H. Region 3 (Post 820201)

TO: LOOP. F. Cleveland Clinic Foundation. Cleveland. OH ISSUED: 920326 AVAIL PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9204070016*

TASK: ODID: DIN: 920326 DPN: DRN:

DOCKET NO' 03002649 03317031 FICHE: 61229 lb7 61228 164 RIDS: IEO7D 9204070227 Confirms 920323 telcon in which recipient agreed to continue representing NRC as medical consultant in matter relating to crecent medical therapy misadministration at Cleveland Clinic Foundation.

FROMi SCHULTZ.N.H. Region 3 (Post 820201')

TO: MIRALDI,F.D. University Hosps. of Cleveland. Cleveland, OH ISSUED: 920327 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9204070227-TASK: ODID: DIN: 920327 DPN: DRN:

DOCKET NO: 03002649 FICHE: 61229 071 61229 075 RIDS: IEO7D-

t 8'20/92

/ PAGE 36 U. S. NUCLE AR REGULAT ORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 19204240241 Mat 15 licensing package for amend 52 to license 34-00466-01 for Cleveland Clinic Foundation. Control: 393046.

FROM: JONES,J.D. Region 3 (Post 820201)

TO:

ISSUED: 920409 AVAIL: PDR 16pp. DOCUMENT TYPE: TLLMDL FPAC: 9204240241 TASK: ODID: 393046 DIN: 34-00466-01 DPN: 'A52 DhN:

DOCKET NO: 03002649 FICHE: 61458 337 61458 352 RIDS: ML30D.

9204230044 Ack receipt of 920312 submittal showing compliance w/ _

condition 21 of license 34-OO466-OI. Condition requires _that licensee submit monthly rept te radiation safety program.

-Submittal satisfies requirements ?x acceptable.

FROM: GROBE,J.A. Region 3 (Post 820201)

TO: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 920416 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FP AC.: 9204230044 TASK: ODID: EA-91-OG4 DIN: 920416 DPN :- DRN:

DOCKET NO: 03002649 FICHE: 61395 173 6139S 173 RIDS: IEO7D 9205190188 Responds to NRC 920326 ltr re violations noted in insp rept 30-02649/92-01 on 920128-29. Correctave actions.two radiation therapy technologists veceived complete review of

. appropriate storage handling, verification & procedures.

FROM. KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: SCHULT2,W.H Region 3 (Post 820201)

ISSUED: 920417 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9205190182A TASK: ODID: DIN: 920417 DPN: DRN:

DOCKET ND' 03002649 F I CHE: 61706 149 61706 150 RIDS:

9205190182 Ack receipt of 920417 Itr informing NRC of steps taken to correct violations noted in insp rept 30-02649/92-01.

FROM: SCHULTZ,W.H. Regton 3 (Post _820201).

TO: LOOP,F. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 920508 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 920S190182*

TASK: ODID: DIN. 920508 DPN: DRN:

DOCKET NO: 03002649 FICHE: 61706 14G 61706 ISO RIDS: IEO7D 9200140034 Package consisting of partially deleted pages of 14G page record te 910516 spill-of radioactive matl at Cleveland

' Clinic.

FROM:

NRC - No Detailed Affiliation Given TO:

!SSUED: 920814 AVAIL: PDR 2pp. DOCUMENT TYPE: -VADPKG FPAC: 9208140019A TASK: ODID: DIN: DPKG-920814 DPN: DRN:

DOCKET NO: 03002649 F IC HE: 62772 245 62772 271 RIDS:

. . - - .. .- . _ _ . .- . _ - . . ~ . - . = . - . - ., . . . . .

8/20/92 PAGE 3 7. .

.U. S, NUCLEAR. REGULATORY COMMISSION

, DCS PARTIAL RECORD FORMAT REPORT 9208140034-01 PackageLconsisting of partially deleted pages of 148 page vecord re 910516 spill of radioactive matl at-Cleveland Clinic. ,

FRON:

NRC - No Detailed Affiliation Given VO:

. I SSUED: 920814 AVAIL: PDR 2pp, DOCUMENT TYPE: VADPKG FPAC: 9200140019A VASK: ODID: DIN: DPKG-920814 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62772 24S 62772 271 RIDS:

l

[

,ugni am_yg u .:. ,.m. .1 s --

p g. ,90-/ W 7 THIS DOCUMENT WAS PRODUCED BY TK N U. S. NUCLEAR REGULATORY COMMISSIt NUDOCS

~

OPERATED-BY ETATISTICA, INC, UNDER CONTRACT NO NRC-39-88-21 1

- . ~ . . . .

8/20/92 PAGE 1 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT. I 8111110784 IE Insp Findings & Licensee Ack dtd 811028- of Licenses 34-00466-02 & 34-OO466-03.Insp findings:no noncompliance noted.

FROM: DURGIN,R.E. Region 3, Oft of the Director (810301-820201)

TO:

ISSUED: 811028 AVAIL: PDR 1 p. DOCUMENT TYPE: TIIFLA FPAC: 8111110784 TASK: ODID: DIN: IFLA-811028-02 DPN: DRN:

DOCKET NO: 03000394 03014577 F ICHE: 10603 061 10603 ' 061 - R I DS: IEO7S 8312050269 Discusses IE insp of Licenses 34-00466-01,34-00466-02, 34-00466-03 & 34-00466-04 on 831117 & forwards notice of violation.

FROM: GRENIAWSKI,D.J. Region 3 (Post 820201)

TO: PAVLICEK,W. Cleveland C12nic Foundation, Cleveland, OH ISSUED: 831129 AVAIL: PDR 1p DOCUMENT TYPE: CLOUT. FPAC: 8312050269*

TASK: ODID: DIN: 831129 -DPN: DRN:

DOCKET NO 03000394 03002L49 03014577 F IC HE: 21381 195 21381 196 RIDS: IEO7Sf 8410310066 Application for amends to Licenses 34-00466-02,34-00466-03, 34-00466-04 & SNM-1659. authorizing SJ Aron as radiation .

safety officer.' Fee paid.

FROM: ARON.S.J Cleveland C12nic Foundation. Cleveland, OH TO: Materials Licensing Dranch

~ ISSUED: 840810 AVAIL: PDR 26pp. DOCUMENT TYPE- TL.MBL FPAC: 8410310046B TASK: ODID 77295 DIN: AMBL-640810 DPN: DRN:

-DOCKET NO. 03000394 07002213 03D14S77 F I CHE: 27228 129 27228- 154 RIDS:

E410310288 Amend 6 to License 34-00466-03 for-Cleveland Clinic Foundation, changing Condition.12 re authorized users of ,

matl, FROM: HOLT D J. Region 3 (Post-820201)

TO:

ISSUED 840822 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL' FPAC: '8410310288-TASK: ODI D- DIN: 34-00466-03 DPN: A06 DRN; DOCKET NO: 03014577 F ICHE: 27226 318 27226 332 RIDS: ML3OL' 8410310057 Forwards Amend 16 to License 34-OO466-02 Amend 6 to 34-OO466-03, Amend 2 to 34-00466-04 &-Amend 2 to SNM-16S9.

Document should be reviewed 4-all condi tions understood; FROM: HOLT,B.J. Region 3 (Post 820201)

TO: ARON,S.J. Cleveland Clinic Foundation. Cleveland,-OH ISSUED: 840928 AVAIL: PDR 2pp, DOCUMENT: TYPE:. CLOUT FPAC: 8410310046A TASK: ODI D: DINi 840928 DPN: DRN:

DOCKET . NO: 03000394 07002213 03014577 FICHE: 27228 127 27228 128 RIDS:

m__ .. . . _ . . . _ _ . _ . _ . . - . _ . _ . _ - _ _ _ _ _ _ _ _ _ . _ _ _ _

8/20/92 PAGE 2 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT-

'8801110110 . App 1~ication for amends to Licenses 34-00466-02 &

34-OO466-03, authorizing use of licensed matl by P Higgins, .

C Sibata,W McCarthy,J Ulue & W Roberts.for nonhuman use &

SJ Aron as radiation safety ~ officer. Fee paid.

FROM: ARON,S.J. Cleveland Clinic Foundation. Cleveland, OH TO: Region 3 (Post 820201)

- I SSUED: 870115 AVAIL: PDR 23pp. DOCUMENT TYPE: TLAMBL FPAC: 8801110104B i TASK: ODID: 8281S DIN: AMBL-870115- DPN: DRN: >

DOCKET NO: 03000394 03014577 FICHE: 43971 223 43971 245 RIDS:

8704220187 Forwards radiation safety incident rept te release of -

rad 2oactive ashes from incinerator room, reported-on 870206.

Loss of licensed mati does not-appear to be substantial hazard to persons in unrestricted areas.

FROM: ARON S.J. Cleveland Clinic Foundation, Cleveland, OH TO: W1EDEMAN,D. Region 3 (Post 820201)

ISSUED: 870212 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC: 8704220130D TASK: ODID: DIN: 8702J2 DPN: DRN:

DOCKET NO- 03000394 030026.9 03014577 F ICHE: 40620 143 40620 145 RIDS:

8704R20187 XA Forwards radiation safety incident rept te release of

. radioactive ashes From incinerator roomireported on 870206, Loss.of itcensed mati does not appear to be substantial hazard to persons in unrestricted areas FROM: ARON,SLJ. Cleveland Clinic Econdation, Cleveland, OH TO: WIEDEMAN,D. Region 3 (Post 820201)

ISSUED: 870212 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC: 9207080132A-TASK: ODID: DIN: 870212 DPN: DRN:

DOCKET NO: 03000394 03002549 03014577 FICHE: 62262 130 62262 137 RIDSi ;

8704220166 Responds to 87012e 1tr modificc by 870304 enforcement conference Licenses offers to amend L2 censes 34-00466-01, 34-00466-02 L 34-00466-03 to include enc 1 GA/GC statementuof

principles for dept of radiation therapy.

FROM: KISER,W.S. Cleveland C l i n i c: Foundation, Cleveland, OH TO: HIND,J A. Region 3'(Post 820201)

ISSUED: 870313 AVAIL: PDR 7pp. DOCUMENT TYPE: CLINC- FPAC: 8704220130C-T ASK: ODID: LIN: 870313 DPN: DRN:

DOCKET NO: 03000394 03002649 03014577 FICHE: 40620 136- 40620 142 RIDS:

8704220166 XA Responds to 870126 Itr, modified by 870304 enforcement conference Licensee offers to amend Licenses-34-OO466-01,

. 34-00466-02 & 34-00466-03 to include enci GA/GC-statement of principles--for dept-of-radiation therapy.

FROM: KISER W.S. Cleveland Clinic Foundation, Cleveland, OH-TO: HIND J A. .

Region 3 (Post 820201)

ISSUED: 870313 AVAIL: PDR 7pp. DOCUMENT TYPE: CLINC FPAC:-9207080132A TASK: OD I D :- DIN: 870313 DPN: DRN:

g DOCKET NO: 03000394 03002649 03014377 FICHE: 62262 123 62262 129_ RIDS:

4

, . ,-. . _ ,,--r,.,# ..m.

m.mm.ama;mw L G : a u = 2" 8/20/92 PAGE 3 U. S. NUCLEAR REGULA1 DRY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 8704220130 Forwards Safety Insp Rep .s 30-02649/87-01,30-00394/87-01, 30-14577/87-01,30-17931/87-01 4 70-3044/87-01 on 870323-25 &

notice of violation. Concern re mgt control sys expressed h improvementi requested, FROM: AXELSON.W.L. Region 3 (Post 820201)

TO: KISER,W,5 Cleveland Clinic Foundation, Cleveland, OH ISSUED: 870415 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8704220130*

TASK: ODID: DIN: 870415-01 DPN: DRN:

DOCKET NO 03000394 03002649 03014577 FICHE: 40620 116 40620 145 RIDS: IEO7D 8704220130 XA Forwards Safety Insp Repts 30-02649/87-01,30-00394/87-01, 30-14577/87-01,30-17931/87-01 & 70-3044/87-01 on 870323-25 &

notice of violation. Concern re mgt control sys expressed &

improvements requested.

FROM: AXELSON,W.L. Region 3 (Post 820201)

TO: KISER,W.S. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 870415 AVAIL: POR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9207080132A TASK: ODID: DIN: 870415-01 DPN: DRN:

DOCKET NO. 03000394 03002649 03014577 FICHE: 62262 103 62262 137 RIDS: IEO7D 8704220146 Notice of violation from insp on 870323-25.

FROM: AXELSON,W.L. Regton 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 6pp. DOCUMENT TYPE: TINVID FPAC: 8704220130A TASK: ODID: 30-02649/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO 03000394 03002649 03014577 FICHE: 40620 118 40620 123 RIDS: -

8704220146 XA Notice of violstaon from insp on 870323-25.

FROM: AXELSON,W.L. Region 3 (Post 820201)

TO:

ISSUED: 670415 AVAIL: PDR 6pp. DOCUMENT TYPE: TINVID FPAC: 9207080132A TASK: OD I D. 30-02649/87-01 DIN: 30-00394/07-01 DPN: DRN:

-DOCKET NO- 03000394 03002649 03014577 FICHE: 62262 105 62262 110 RIDS:

8704220158 Insp Repts 30-02649/87-01,30-00394/87-01,30-14577/87-01, 30-17931/87-01 & 70-3044/87-01 on 870323-25. Violations noted: failure to conduct semiennual audits. conduct monthly surveys maintain records L post cautior signs.

FROM: LYNCH,J,L. Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE: TIINSP FPAC: 8704220130D TASK; ODID: 30-02649/87-01 DIN: 30-00394/87-01 DPN: DRN:

DOCKET NO- 03000394 03002649 03014577 FICHE: 40620 124 40620 135 RIDS:

-- _ . - - - . . - . - -- .= . _ -= .. . ~ - - . . . . . . -

-8/20/92- PAGE 4 U. S.-NUCLEAR REGULATORY COMMISSION

DCS PARTIAL RECORD FORMAT REPORT .

87042201D8 XA Insp Repts 30-02649/87-01,30-00394/87-01,30-14577/87-01, 30-17931/87-01 t< 70-3044 /87-01 on 870323-25. Violations noted: f ailure to conduct semiannual audits, conduct monthly surveys maintsin records 6 post caution signs,

_FROM: LYNCH.J.L. . Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE: TIINSP FPAC: 9207080132A TASK: ODID- 30-02649/87-01 DIN: 30-00394/87-01 DPN: DRN:

DDCKET NO. 03000394 03002649 03014577 FICHE: 62262 111 62262 122 RIDS:

8801110104 Amend 8 to License 34-00466-03 for Cleveland Clinic Foundation, amending Condition.12 authorizing WK Roberts, JW D1ue,F Higgins,C Sibata or W McCarthy to use licensed matis & SJ Aron as radiation protection officer.

FROM: WHISTON,P.J Region 3 (Fost 820201)

TO:

1SSUED: 870730 AVAIL. PDR 1p_ DOCUMENT TYPE: TLLMBL-FPAC: 8801110104*

TASK: ODID: DIN: 34-00466-03 DPN: AOS DRN:

DOCKET NO. 03014577 FICHE. 43971 220 43971 245 RIDS: ML30D 8801110106 Forwards Amend 3 to License 34-00466-03.

FROM: WH]STON P.J. Reg 2on 3 (Post 820201)

TO: ARON,S.J. Cleveland C12n2c Foundation, Cleveland, OH ISSUED: 870731 AVAIL PDR 2pp, DOCUMENT TYPE: CLOUT FPAC: 8801110104A TASK: OD DIN: 870731 DPN: DRN; DOCKET NO: 03014577 FICHE: 43971 221 43971 222 RIDS:

9207230063 Informs of G80524 misadministration of-radiopharm. Patient injected w/.611 mci Tc-04-99 instead of 12 mci Tc-99m DTPA for_ renal scanLCaused by personnel selecting wrong syringe from dosage cart. Personnel reinstructed.

FROM: ARON,5.J, -Cleveland Clinic Foundation, Cleveland, OH TO: WIEDEMAN,D. Region-3 (Post 820201)

ISSUED: 880613 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9207150108A TASK: OD1 D: DIN: 880613-01 DP N: DRN:

DOCKET NO: 03014577 FICHE: 62546 047 62546 048 RIDS:

9207230063 01 Informs of 880524 mitadministration of radiopharm Patient injected w/.611 mci Tc-04-99 instead of'12 mci-Tc-99m DTPA ~

for renal scan. Caused.by personnel selecting wrong syringe from dosage cart. Personnel reinstructedi FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: WIEDEMAN,D. Region 3'(Post 820201)-

ISSUED: 880613 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9207150108A TASK: ODI D: DIN! 880613-01 DPN: DRN:

-DOCKET NO: 03014577 FICHE: -62546 047- -62546 048 RIDS:

N d

=

18/B0/92 PAGE 5l d U. S. NUCLEAR REGULATORY I;OMMISSION l d

DCS PARTIAL RECORD FDPMAT REPORT :l

-1

.9006050128 Matls licensing package for Amend 10 to L-icense 34-00466-03 l

'for Cleveland Clinic Foundation Control: 303571.

-FROM: PELKE,P.J. Region 3 (Post 820201)

TO:

ISSUED: 881212 AVAIL: PDR 20pp. DOCUMENT TYPE: TLLMBL FFAC: 9006050128:

TASK: ODID: 383S71 DIN: 34-00466-03 DPN: 'A10 DRN:

DOCKET NO: 03014S77 FICHE: 53995 317 53995 336 RIDS: ML30D 19003130760 Matls licensing package for Amend 12-to License 34-00466 for Cleveland Clinic Foundation. Control: 386208.

FROM: MATSON.E.R Region 3 (Post 820201)

TO:

ISSUED: 890127 AVAIL: PDR 108pp DOCUMENT TYPE. TLLMBL. FPAC: 9003130760 TASK: ODID; 386208 DIN: 34-00466-03 DPN; A12 DRN:

DOCKET NO. 03014577 FICHE: 52955 244 S2955 351 R I DS: ML30D 8912200118 Confirmatory Action Ltr CAL-RIII-89-24 re use of telethorapy unit at NASA,per 891213 telcon FROM: DAVIS,A.B. Region 3 (Post 820201)

TO: LEES,J.E. Cleveland Clinic Foundation. Cleveland, OH ISSUED: 891214 AVAIL: PDR 1p DOCUMENT TYPE: CLOUT FPAC: 8912200118 TA9K: ODID CAL-RIII-89-24 DIN: 891214 DPN; DRN:

DOCVET NO: 03014377 FICHE: 52075 159 S2075 159 RIDS: IEO7D

.9005080120 Forwards Safety Insp Repts 30-02649/90-01,30-00374/90-01,

.30-14S77/90-01 L 70-3044/00-01 t.n 900307-0405. Violations &

repeat concern for lack of cooperation between' therapy dept-k radiation safety ofc identified.

FROM: NORELIUS,CLE. Region 3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation, Cleve' land,,OH I SSUED: 900427 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9005080120*

TASK: ODID: EA-90-074 DIN: 900427 .

DPN DRN;

DOCKET NO: 03002649 03000394 - 03014577 FICHE: 53769 299 S3769 351 RIDS: IEO7DL 9005080128 _ Safety Insp Repts 30-02649/90-01,30-00394/90-01, 30-14S77/90-01 &'70-3044/90-01 on 900307-09,14-16 & 0313 &

19-0405. Major areas inspected: review of licensed programs.

organization, internal audit program L notifications & repts.

FROM: MATSON,E.R. Region 3 (Post 820201)

TO:

ISSUED: -900427. AVAIL: PDR 51pp. DOCUMENT TYPE: TIINSP FPAC: 900SO90120A-~

TASK: ODID: 30-00394/90-01 DIN: 30-02649/90-01 DPN: DRN:

DOCKET NO: 03002649 03000394 03014577 FICHE: 53769 301 53769 351 RIDS:

.re:. pes , .=w -

, . :v-

j. . . . ,. _

i 8/20/92. PAGE '6 U S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT

.9005290279 Safety Insp Repts 30-02649/90-02,30-00394/90-02 L )

00-14577/90-02 on-900307-09,14-16 & 0419-20. Violations noted. Major areas inspected: allegations received on 890829 I

l re licensee.

FROM: MATSON,E.R. Region 3 (Post 820201) ;

TO:

! ISSUED: 900518 AVAIL: PDR 40pp. DOCUMENT TYPE: TIINSP FPAC: 9005290275B TASK: ODID* 30-02649/90-02 DIN: 30-00394/90-02 DPN: DRN:

DOCKET NO. 03002649 03000394 03014577 FICHE: 53947 261 53947 300 RIDS:

9005290275 Forwards Safety Insp Repts 30-02649/90-02,30-00394/90-02 &

30-14577/90-02 on 900307-0420 L notice of violation.

FROM: NORELIUS,C.E. Region-3 (Post 820201)

TO: LOOP,F. Cleveland Clinic Foundation,- Cleveland, OH I SSUED: - 900522 AVAIL: PDR 2pp. DOCUMENT TYPE-. CLOUT FPAC:. 9005290275*

TASK: ODI D' DIN: 900522 DPN: DRN:

DOCKET NO. 03002649 03000394 03014577 FICHE- 53947 257 53947 300 RIDS;- IEO7D 9206180341 Forwards Region III insp rept in response to 890105 request' for' info re allegation RIII-89-A-OOO1.

FROM: FUNK,D.E. Regson 3 (Post 820201)

TO: PAWLIK,E.T. Regton 3 (Post 820201)-

ISSUED: 900625 AVAIL: FDR 1p. DOCUMENT TYPE- CMMEMO FPAC: 9206180321A TASK: ODID- DIN: 900625 DPN: DRN:

DOCKET NO- 03002649 03000394 03014577 F ICHE: 62105 032 62105 072 RIDS:

9010240376 Matls 12 censing package for Amend 13 to License 34-00466-03

-for Cleveland Clinic Foundation Control: 389995.

FROM: HUETER,L J. Region 3 (Post 820201)

TO:

ISSUED: 900809 AVAIL: PDR 8pp. DOCUMENT: TYPE: TLLMBL FPAC: -9010240376 TASK: ODID: 399995 D I N :- 34-00466-03 DPN: A13 - DRN:

DOCKET NO. 03014577 FICHE: 55486 351 55486-359 RIDS: ML30D 9012030046 10 Forwards demand for info re decommissioning funding. plan or.

certificate that financial assurance for decommissioning has been provided.

t FROM: DAVIS A.D. Region 3 (Post 820201) l TO: SteriGenics International (formerly Radiation Sterilize-ISSUED: 901102 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: .901203OO18A-TASK: ODID: DIN: 901102 DPN: DRN:

DOCKET NO: 03019025 03022539 03014577. FICHE; 36095 089 56095 118 RIDS:

- ~ . , - . . , . . , - . .- - _ - .,._--;,_-...-a- _

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. .- - - . . - -.- -. . - .. . . . -.- - ~ - - . . . . . .

8/20/92 -PAGE 7 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT r

9012030018 10 Forwards demand for info ltr dtd1901102.Ltr issued to Part 30 licensees,per 900727 ltr requiring 10CFR30.35 compliance.

FROM: PAPPAS,H. Region 3 (Post 820201)

TO: Region 3 (Post 820201)

ISSUED: 901109 AVAIL: PDR 1 p. DOCUMENT TYPE: CMMEMO FPAC: 9012030018* ,

-TASK: ODID: DIN: 901109 DPN: DRN:

DDCKET NO: 03019025 03022S39 03014577 FICHE: 56095 088 56095 118 RIDS: IEO7D-

-9102250190 Volded matis licensing action for License- 34-00466-03 for Cleveland Clinic Foundation, Control: 390698.

FROM: JONES,J. Region 3 (Post 820201)

TO: NRC - No Detailed Affiliation Given ISSUED: 910214 AVAIL: PDR Spp. DOCUMENT TYPE: CMMEMO FPAC 9102250190 TASK: ODID- 390698 DIN: 910214 DPN: DRN:

DOCKET NO: 03014577 FICHE: S6802 043 S6802 050 RIDS: ML30D 9105200298 Matis licensing package for amend 14 to license 34-00466-03 for Cleveland Clinic Foundation Control: 391011 FROM:- JONES,J.D. Region 3 (Post 820201)

TO:

ISSUED: 910219 AVAIL: PDR Spp. DOCUMENTcTYPE: TLLMBL FPAC: 9105200298 TASK'; ODID. 391011 DIN: 34-00466-03 DPN. A14 DRN:

DOCKET NO: 03014577 FICHE: S7792 256 57792 264 RIDS: ML30D l

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pat 30-/793i THIS DOCUMENT WAS ' PRODUCED BY THE U. S. NUCLEAR REGULATORY COMMISS!f NUDOCS OPERATED BY STATISTICA. INC.

UNDER CONTRACT NO..NRC-39-88-21'

8/20/92 PAGE 1 U. S. NUCLEAR REGULATORY COMMISSION-DCS PARTIAL RECORD FORMAT REPORT 83120$0269 01 Discusses IE insp of Licenses 34-00466-01,34-00466-02, 34-00466-03 & 34-00466-04 on 831117 & forwards notice of violation.

FROM: SRENIAWSKI D.J. Region 3 (Post 820201)

TO: PAVLICEK.W. Cleveland Clinic Foundation, Cleveland, OH ISSUED. 831129 AVAIL PDR 1p. DOCUMENT TYPE. CLOUT FPAC: 8312030269*

TASK: ODID: DIN: 831129 DP N:' DRN:

DOCKET NO: 03000394 03017931 FICHE: 21381 195 21381 196 RIDS:

8410310270 Amend 2 to License 34-00466-04 for Cleveland Clinic Foundation, changing Condition 12 re radiation safety officer.

TROM: HOLT,B.J. Region 3 (Post 820201)

TO:

ISSUED: 840822 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8410310270 TASK: ODID: DIN: 34-00466-04 DPN: A02 DRN:

DOCKET NO: 03017931 FICHE: 27226 303 27226 317 RIDS: ML3OL B311270187 Notifies of new address to ensure delivery to correct location within foundation.

FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: STAN5DURY,T.R NRC - No Detailed Affiliation Given ISSUED- 850924 AVAIL- PDR 1r DOCUMENT T YPE: CLINC FPAC: BS11370184A TASK- ODID 79941 DIN: 850924 DPN: DRN:

DOCKET NO- 03000394 03002649 03017931 F I CHE : 33645 103 33646 103 RIDS:

85112701S4 Amend 3 to License 34-00465-04 for Cleveland Clinic Foundation, changing address.

FROM: MATSON,E.R. Pegion 3 (Post 820201)

TO.

ISSUED: 8S1105 AVAIL: PDR 1p- DOCUMENT- TYPE: TLLMGL FFAC: 8511270184*

TASK: ODI D: DIN: 34-00466-04 DPN: A03 DRN:

DOCKET NO: 03017931 FICHE: 33646 102 33646 103 RIDS: ML3OL 8610030362 Application to amend License 34-OO466-04, authorizing use.of max 1,200 Ci' Cs-137 in AECL-RCC Gammacell-1000-blood ,

irradiater,Model A,for irradiation of blood, blood components 5 biological samples & matls. Fee paid FROM: ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

I SSUED: 860523 AVAIL: PDR 3pp. DOCUMENT TYPE: TLAMBL FPAC: 8610030337B T ASK: ODID: 81431 DIN: AMBL-860523 DPN: DRN:

DOCKET NO: 03017931 FICHE: .38079 316 38079 318 RIDS:

0/20/92 PAGE D !

U. S. NUCLEAR RPOULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT ,

i D610030337 Amend 4 to Lic ens 9 34-00466-04 for Cleveland Clinic Foundation,authori Ing use of ma n 720-C1 Cs-137 scaled sources in AECL Gamma Cell 1000 A tiradiator for -

irradiation of blood ti biologic al temples & mat 15, l FROM: WHISTON,P.J. Region 3 (Po6t 020201) :

TO:

IGSUED: 060722 AVAIL: PDR 1 p. DOCUMENT TYPE, TLLMDL FPAC: 8610030337*

1ASK: OD1D: DIN: 34-00466-04 DPN: A04 DRN:

DOCKET NO: 03017931 FICHE: 30079 312 38079 315 RIDS: ML30L l

., G610030300 Forwards Amend 4 to License 34-00466-04, Condition 16 [

requires that licensee perform radiation survey prior to ,

initiation of irradiation program & submittal of Survey respits. Record of G60602 telcon enc 1. 7

+

FROM: NH1STON,P.J. Region 3 (Post 020201)

TO: ARON,S J. Cleveland C11nte Foundation, Cleveland, OH ISGUED: G607k2 AVAIL; PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 8610030337A

TAGK: ODID: DIN: 060722 DPN: DRN:

DOCKET NO: 03017931 F1CHE: 30079 313 30079 310 RIDS:

8611250379 Confirmatory action ltr t e Co-60 t el e t h erapy ,

misadmiraistration reported on U61117 Actions to be t a k e r. to ,

I prevent rec ur renc e of error listed FROM: KEPPLER,J.G. Regton 3 (Post 020201)

TO: THOMAS,F Cleveland Clinic roundation, Cleveland, OH !

1SSUED: G61120 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 0611250379 '

TAEK' 0D10- CAL DIN: 861120 DPN: DRN.

DOCKET NO: 03017931 RICHE: 30707 221 30707 222 RIDS: IEO7D ,

0611250379 X A Confirmat ory ac tion I tt t- Co-60 teletherapy mitadministiation repotted on D6!!17 Actions to be taken to prevent recurrente of error 12sted.

L FROMi KEPPLER.J.O. Region 3 (Post 820201)

TO: THOMAS,r. Cleveland Clinic Foundation, Cleveland, OH ISSUED: G61120 AVAIL PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9206100358A TASK: ODID: CAL DIN: 861120 DPN; DRN:

DOCKET NO: 03017931 FICHE: 6" 7 109 62105.110 RIDS:

0001050274 Application for amend to Licent-e 34-0046(..-04, nothorizing use of AECL Cs-137 itradiator Enti survey results show less than

.005 uCi leakage attivity.Intervice instruction / training will preceed use.

FROM: ARON.S.J. Cleveland Clinic Foundation, Clevelond, OH TO: WHISTON,P.J. Region 3 (Port 020201)

ISSUED: 061217 AVA3L: PDR 2pp.- DOCUMENT TYPE: TLAMBL FPAC: 88010DO256A TASK: ODID: 82684 DIN: AMDL-061217 DPN: DRN:

DOCKET NO: 03017931 FICHE: 43913 137 43913 139 RIDS:

M

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- . - . - - - - - - . - ~ - - - - . _ - - - . . . _ - . - - - . ~ . -

i

! 8/20/92 PAGE 3 ,

1 U S. NUCLEAR REGULATORY COMMISSION !

DCS PART]AL RECORD FORMAT REPORT l i

B704220187 01 Forwards radiation safety incident rept te release of f

' radioactive ashes from incinerator room, reported on 870206. :

Loss of licensed mati does not appear tu be substantial l hazard to persons in unrestricteo areas.

FROM: ARON,S J. Cleveland Clinic Foundation, Cleveland, OH TO: WIEDEMAN,D. Region 3 (Post B20201)

ISSUED: 070212 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC; 8704220130D TASK: ODID: DIN: 070212 DPN: DRN: )

DOCKET NO: 03000394 03017931 07003044 FICHE' 40620 143 40620 145 RIDS: f G704220130 01 Forwards Safety Insp Re p t s 30-02649/ 07-01,30-00394/07-01, ,

30-14577/07-01,30-17931/G7-01 & 70-3044/87-01 on 870323-25 & ;

notice of violation, Concern te mgt control sys empressed &

improvements requested FROM: ATELSON,W.L. Region 3 (Post D20201)

< TO: R 1 bER , W S. Cleveland Clinic Foundation, Cleveland, OH ISSUED: 870415 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 0704220130* i TASK: OD ! D. DIN: 870415-01 DPN: DRN:

DOCKET NO 03000394 03017931 07003044 FICHE: 40620 116 40620 140 RIDS: LEO 7D-9704220130 XB Forwards Safety Insp Repts 30-02649/87-01,30-00394/87-01, 30-14577/97-01,30-17431/E7-01 L 70-3044/07-01 on 870323-25 b notice of violation. Conc &rn te mgt c ont t 01 sys espressed L improvements requested FROM: AxELSON,W L. Region 3 (Post 820201)

TO: KISER,W 5. Cleveland C12nic Foundation, Cleveland, OH ,

ISSUED: 070410 AVAIL PDR 2pp DOCUMENT TYPE: CLOUT FPAC: 9207000132A ,

T ASK: ODID DIN: 870415-01 DPN: DRN:

DOCKET NO- 03000394 03D17931 07003044 FICHE: 62262 103 62262 137 RIDS: IEO7D 0704220146 01 Notice of vtolation from insp on 870323-25

+ FROM: ATELSON,W.L Regton 3 (Post G20201)

TO:

DOCUMENT TYPE: TINVID FPAC: 8704220130A ISSUED 87041S AVAll PDR 6pp TASK; ODID: 30-14577/07-01 DIN. 30-00394/07-01 DP N : DRN:

DOCKET NO. 03000394 03017931 FICHE. 40620 lie 40620 123 RIDS:

l 0704220146 XD Notice cf v2oletion from insp on G70323-20

- FROM: AXEL 3ON,W,L. Regson 3 (Post 620201)

TO:

ISSUED: 870415 AVAIL. PDR 6pp. DOCUMENT TYPE, TINVID TPAC: 9207080132A TASK: ODID: 30-14S77/87-01 DIN: 30-00294/07-01 DPN: DRN:

DOCKET NO: 03000394 03017931 FICHE: 62262 IOS 62262 110 RIDS:

i

_ . - - - _ . ~ - - - , , _ . _ - _ . _ , . , _ _ , _ _ _ _ . _ _ _ _ . ~ . _ , . _ _ _ _ . _ _ _ _ _ -

8/20/92 PAGE 4 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTinL RECORD FORMAT REPOR7 0704220138 01 Insp Repts 30-02649/87-01,30-00394/87-01,30-14S77/87-01, 30-17931/87-01 t< 70-3044/07-01 cn 870323-25. Violations noted'fejlure to conduct semiannual audit s, c onduc t monthly ,

surveys. maintain records b post caution signs.

TROM- LYNCH,J.L. Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE: T11NSP TPAC; 87042201300 ;

T ASK: ODID: 30-14577/07-01 DIN' 30-00394/87-01 DPN: DRN: .

DOCKET NO: 03000394 03017931 07003044 FICHE: 40620 124 40620 135 RIDS:

8704220150 XB Insp Repts 30-02649/87-01,30-00394/87-01,30-14577/07-01, 30-17931/87-01 & 70-3044/87-01 on 870323-25. Violations noted: f ailure to conduct semiannual audits, conduct monthly surveys, maintain records & post caution signs.

FROM: LYNCH.J.L. Region 3 (Post 820201)

TO:

ISSUED: 870415 AVAIL: PDR 12pp. DOCUMENT TYPE: T!INSP FPAC: 9207000132A TASK: OD I D- 30-14577/87-01 D!N: 30-00394/87-01 DPN: DRN:

DOCKE1 NO: 03000394 03017931 07003044 FICHE 62262 til 62762 122_ R I DS: .

8801030256 Amend 5 to Licente 34-00466-04 for Cleveland Clinic Foundation. amending condition 18 r e conduct of program FROM: MCCANN,G.M. Region 3 ( P o t. t B20201)

TO: J ISSUED: D70617 AVAIL- PDR 1p DOCUMENT TYPE' TLLMDL TPAC; 8801050256*

TASK: ODID: DIN: 34-00466-04 DPN: A05 DRN:

DOCKET NO 03017931 FICHE' 43913 136 43913 138 RIDS: ML30D 9207210300 Informs of 470828 misadministration,of radiopharm. Patient received 0 56 mci Tc-99m instrument calibt source labeled "Not.for. Human Use " Caused oy personnel error. Technologist cautioned to recheck labels before injecting.

FROM: ARON,5 J. Cleveland Clinic Foundation. Cleveland, OH TO: Office of Nuclear Maternal Safety & Safeguards I SSUED: 870903 AVAIL- PDR 3pp. DOCUMENT TYPE: CLINC FPAC: 9207130100A TASK: OD10: DIN: -870903-01 .DPN: DRN:

DOCKET NO: 03017931 FICHE: 62546 041 62546 043 RIDS:

8807180103 Applicat2on for amend to License 34-OO466-04. authorizing needed maint of JL Shepherd Cs-137 irradiator by clinic p er s onn e l . F c-e p a i d.

FROM: -ARON,S J. Cleveland C11nac Foundation, Cleveland, OH TO:

ISSUED: 871022 AVAIL: PDR 17pp. DOCUMENT TYPE: TLAMDL FPAC: 0807180092C TASK: ODID: 84360 DIN: AMBL-871022 DPN: DRN:

DOCKET NO: 03017931 FICHE: 46199 273 46199 287 RIDS:

U/20/92 PAGE D U. S. NUCLEAR REGULATORY COMMISSION l l

DCS PARTIAL RECORD FORMAT REPORT j l

0807180100 Provados clarifications to 871022 application for amend to l License 34-00466-04,per 880027 telron ,

I !

FROM: ARON,S.J. Cleveinnd Clinic Foundation, Cleveland, OH ;

TO: Region 3 (Post 820201) ,

ISSUED: 880229 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC: 8807180092B TASK: ODID: 04360 DIN: 880229 DPN: DRN: !

DOCKET NO: 03017931 FICHE: 46199 270 46199 272 RIDS: .

8807180092 Amend 6 to License 34-00466-04 for-Cleveland Clinic Foundation, changing Condition-18 re conduct-of program.

FROM: MCCANN,0 M. Region 3 (Post 820201)

TO:

ISSUED. 060328 AVAIL: PDR Op p . DOCUMENT TYPE: TLLMDL FFAC: 8807180092* ,

TASK: OD I D. DIN: 34-00466-04 DPN: A06 DHN:

DOCKET NO: 03017931 F I C HE :- 46199 266 -46199 287 RIDS: ML30D_ _

0807100094 Forwards Amend 6 to License 34-00466-04 e

FROM; FRAZIER,C, Region 3 (Pott 820201) ,

TO: ARON.S.J, Cleveland Clinic Foundation. Cleveland, OH ISGUED: G80328 AVAIL: PDR 2p p. DOCUMENT TYFE# CLOUT FPAC: 8807180092A .

TASK: ODI D: DIN- 890328 DP N : DRN:

DOCKET NO: 03017931 FICHE ~ 46199 268 46199 269 RIDS:

8808190084 Forwards order modifying 12cente issued.to all users of f JL Shepherd self-shielded irrad2ators (Model 81-22). ;

FROM: W1EDEMAN D.G Region 3 (Post 8D0201)

TO: Cleveland Clinic Foundation. Cleveland, OH ISSUED: 080016 AVAIL: PDP 1p. DOCUMENT TYPE: CLOUT FPAC: 8808190084

TA5K: ODI D. DIN: 880816 DPN: DRN:

DOCKET NO. 03017931 FICHE: 46399 214 46599 217 RIDS: IEO7D -

9006140217 Matis licensing package for Amend 7 to License 34-00466-04 for Cleveland Clinic Foundation. Control: 384360 -

-FROM: MADERA.J.R. Region 3-(Post 820201)-

TO:

ISSUED: 890112 AVAIL: PDR 23pp. DOCUMENT TYPE: TLLMBL FPAC: 9006140217 l

TASK: ODID: 384360 DIN: 34-00466-04 DPN: A07 DRN:

DOCKET NO: 03017931 FICHE: S4158 171 S4158 215 RIDS: ML30D l

L

-,-,..-<,.~a.-,~n-,.-

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na w '

D/20/92 PAGE- 6 U. S NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9111120360 Mat 15 licensing package for amend.G to license 34-00466-04 for Cleveland Clinic Foun d a t i on. C on t r o l : 391 GO4.

FROM: FRAZIER,C. Region 3 (Post 820201)

TO:

ISSUED: 910912 AVAIL: PDR 37pp. DOCUMENT TYPE: TLLMDL FPAC: 9111120360 TASK: ODID: 391804 DIN: 34-00466-04 DPN: AOB DRN:

DOCKET NO: 03017931 FACHE: 59654 136 596S4 172 RIDS: ML30D 9201270235 PNO-III-92-OO1:on 920117, licensee reported that patient received radiation dose 57% greater than prescribed in therapeutic treatment.Licenste investigating event to determine cause of error. Written rept will be s u timi t t e d .

FROM: GLAWINSKI,W. Region 3 (Post 820201)

TO:

ISSUED: 920121 AVAIL PDR 1p. DOCUMENT T YPE: TIPNO1 FPAC: 9201270235 TASK: ODI D: DIN: PNO-III-92-OO1 DP N:. DRNi DOCKET NO; 03017931 FICHE: 60372 171 60372 171 RID 3: IE34D-9204070026 Insp repts 30-02649/92-01 & 30-17931/92-01 on 920128-29.No violations noted. Major areas inspected,irradiators, records, brachytherapy storage room & interviews w/ personnel.

FROM. REICHHOLD,W P. Region 3 (Post 820201)

TO; ISSUED: 92032S AVAIL: PDR 6pp. DOCUMENT TYPE: T11NSP FPAC; 9204070016A T ASK: ODID: 30-17931/92-01 DIN- 30-02649/92-01 DPN: DRN:

DOCKET NO. 03002649 03317931 FICHE: 61220 159 61228 164 R1DS: -

9204070016 Forwards intp repts 30-02649/92-01 f t 30-17931/92-01 on 920128-29 No violations noted Listed areas of concern, including faded color en Cs-137 sources identified.

FROM: SCHULTZ,W.H. Region 3 (Post 820201)

TO: LOOP,r, Cleveland Cisnic Foundation, Cleveland, OH ISSUED: 920326 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9204070016*

TASK: OD1 D: DIN. 920326 DPN: DRN:

DOCKET.NO: 03002649 03017931 FICHE: 61226 157 61228 164 RIDS: 'I EO7D ~

l

. _ . - - - - --. . . - . =, - . - - - _ - - _ . .. . . - -

2/??bdL e y h

THIS DOCUMENT WAS PRODUCED DY THi U. 5. NUCLEAR REGULATORY COMMISSIC NUDOCS OPERATED DY STATISTICA, INC.

UNDER CONTRACT NO. NRC-39-88-21

_ . - _ _ _____.____._.-.___.__.____._.____..__-____-._m i

G/20/92 PAGE 1 U. S. NUCLEAR REGULATORY COMMISSION :

DCS PARTI AL HECORD FORMAT REPORT l i

8702260664 Application for license,authoraring participation in !

research study involving implantation of Nuclear Omni-Stanicor 104A nuclear-powered pacemakers. ,

FROM: CASTLE,L.W. Cleveland Clinic Foundation, Cleveland, OH TO: Division of Fuel Cycle & Material Safety (Pre 870413)

ISSUED: 760206 AVAIL: PDR 2pp DOCUMENT TYPE: TLASNM FPAC: 8702260593J l TASK: ODID: 0325 DIN: ASNM-760206 LPN: DRN:

DOCKET NO: 07002213 FICHE: 39757 327 39757 328 RIDS: I 8702260662 Application for license, authorizing participation in

-research study involving implantation of Coratomic C-100 series nuclear powered pacemakers, -

FROM: CASTLE,L.W. Cleveland Clinic Foundation, Cleveland, OH t 10: Division of Fuel Cycle & Material Gafety (Pre 970413)

ISSUED: 760209 AVAIL: PDR 2pp. DDCUMENT TYPE: TLASNM FPAC: 87022605931- ,

TASK: ODID: 0325 DIN: ASNM-760209 DPN: DRN:

DOCKET NO: 07002213 FICHE: 39757 325 39757. 326 RIDS:

-8702260654 Application for license,authortaing participation in ,

research study involving implantation of Omni-Stanicor 184 nuc l ear -p ower ed pacemakers.

FROM: COOK,G. Cleveland Clinic Foundation, Cleveland, OH TO: VACCA,P Radioisotopes Licensing Branch (Pre 790501)

ISSUED: 760419 AVAIL: FDR 5pp. DOCUMENT TYPE: TLASNM FPAC: 8702260593G TASK: ODID: 1931 DIN: ASNM-760419 DPN: DRN:

DOCKET NO. 07002213 FICHE: 39757 318 39757 322 RIDS: ,

8702260640 Applicatter. tot 1; cense to participate in investigational program utilizing Omni-S tani c o r Model 184A nuclear-powered pacemakers.

FROM: - MOR ANT, V. A- Cleveland Clinic Foundation, Cleveland, OH TO: VACCAsP.C. Radioisotopes Licensing Branch-(Pre 790501)

ISSUED: 760624 AVAIL: PDR 4pp. DOCUMENT TYPE: TLASNM FPAC: 8702260593DA TASK: ODID: 1931 DIN: ASNM-760624 DPN: DRN:

DOCKET NO: 07002213 FICHE: 39757.311- 39757 314 RIDS:

, 8702260633 Forwards list.of members of team, including two thoracic '

. surgeons, Patients regularly followed by telcon on 2-month j basis & check-ups administeled on 3-4-month basis. '

FROM: CASTLE,L.W, Cleveland Clinic Foundation,. Cleveland, OH TO: VACCA,P.C, Rad'ioisotopes Licensing Dranch (Pre 790501)

ISSUED: 760709 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8702260593D TASK: ODID: 1931 DIN: 760709- DPN: . DRN:

DOCKET. NO: 07002213 FICHE: 39757.310 39757 314 RIDS:

6 h

_ , , - , . . , . . - . . - . _ _ - - _ . _ _ . , _ . _ - _ . _ _ , - ~ . _ _ - , . . _ . - . . - . _ _ . . - . _ . _ - - _ -

___._.-_____._____._______m. _ _ _ . _ _ . . _ _ _ _ . _ _

i

.8/20/92 PAGE 2 i U, S. NUCLEAR REGULATCRY COMMISSION !

OCS PARTIAL RECORD FORMAT REFORT i

l 0011120099 Comments on proposed rule tOCFR2O re radwaste disposal.

l Decreases monies spent for burial sites. Reduces risk of accidental leakage during shipment.

b FROM: COOK,5.A. Cleveland Clinic Toundation, Cleveland, OH TO: CHILK.S.J. Office of the Secretary of the Commission ISSUED: 801023 AVAIL: PDR 1 p. DOCUMENT TYPE: CLINC FPAC: 8011120099 r TASK: ODID: 45FR67018 022 DIN: 801023 DPN: DRN:

DOCKET NO: FICHE

06953 307 06953 307 RIDS:

801212O200 Comments on proposed rule 10CFR2O re disposal of liquid scintillation media & animal carcasses containing tritium &

C-14. Supports proposal.

FROM: MACINTYRE,W.J. Cleveland Clinic Foundation,-Cleveland, OH -

TO: Doc k eting & Service s Dranch ISSUED: 001114 AVAIL: PDR 1p DOCUMENT TYPE: CLINC FPAC: 8012120288 >

T ASK; ODID: AbrR67018 274 DIN: 801114 DPN: DRN:

DOCKET NO: FICHE: 07231 324 07231 324 RIDS:

9207160301 Informs of 001216 m1$ administration of redtopharm. Patient inadvertantly injected w/ portion of bone scan dese,namely 7 mC1 of T-99m metidronate,instead of liver scan.No ill effects noted. Adequate study obtained.

FROM: COOK.S.A. Cleveland Clinic Foundation, Cleveland, OH TO: COOPER J. Region Ill, IE (720101-810220)

ISSUED. 810105 AVAIL. PDR 1p, DOCUMENT TYPE. CLINC FPAC: 9207150108A TASK: ODID: DIN. 810105 DPN: DRN; DOCKET NO: 03002649 FICHE- 62546 004 62546 004 RIDS; D107270060 Requests renewal of License SNM-1659 whach expires on

010731 No license fee needs to be 2ntivded for renewal.

Nuclear pacemaker has never be9n implanted nor 2ntended in future for use. '

TROM: PAVLICEK,W, Cleveland' Clinic Foundation. Cleveland,' OH TO: COOPER,J. Region 3, Ofc of-the Director (810301-820201)

ISSUED: 810514 AVAIL: PDR 1p DOCUMENT TYPE; CLINC FPAC: 8107270060 T ASK; ODID: 19239 DIN: 810514 DPN:. DRN:

DOCKET NO: 07002213 FICHE: 09162 362 09162 362 RIDS:

9207160327 Informs of 810522' misadministration of radiopharm. Patient anadvertently injected Tc-99m sulfur colload,Done scan done following day & revealed source of patn. Technologist ,

involved admonished to check patient name w/ isotope.

FROM: COOK.S.A. Cleveland Clinic Foundation, Cleveland, OH TO: COOPER.J. Region 3. Ofc of the Director (810301-820201) 't IS3UED: 810527 AVAIL: PDR 1p. DOCUMENT -TYPE: CLINC -FPAC: 9207150108A TASK: .

DDID: DIN: 810527 .

DPN: DRN: 1 DOCKET NO: 03002649 FICHE: 62546 005 62546 005 RIDS:

D

, , ...v._. - - m - ,, - .- , _..,,-,- - .-., _ , _ _ , _ . _ _ . . , . . , , . - - , . , , < . _ , -- , , , . . ~ , . ~ . , . ~ .

--...s . ~ _ . . . . . .

_m._ ._____ . _ _ _ _ . . _ - . _ _ _ _ _ _ _ _ _ . _ _ _

f 8/20/92 PAGE 3 :

U. S. NUCLEAR REGULATORY COMM15510N i

+

DCS PARTIAL RECORD FORMAT REPORT 1 0704290249 Partially withheld 1tr informing of 820310 misadministration- .

of radiopharm, Patient dose prescription missing from chart & 4 patient given wrong dose. Caused by physician error.

Procedures re doses revised.Related info enc 1.

FROM: RODRIGUEZ,A. Cleveland Clinic Foundation, Cleveland, OH TO: SRENIAWSKI,D. Region 3 (Post 820201)

ISSUED: 620420 AVAIL: PDR I Sp p. DOCUMENT TYPE: CLINC FPAC: 0704290199DA ,.

TASK: ODID: DIN: 820420 DPN: DRN:

DOCKET NO: 03000394 FICHE: 40732 042 40732 056 RIDS:

8209150260 Responds to NRC 620721 Itr re violations noted in IE insp of Lic en s e 34-OO466-02. Correc tive ac ti ons: el ec trome t er calibt B20209.Ertension of time will be r+ quested if :

instruments cannot be calibt before deadline. .

FROM: HORTON.J. Cleveland Clinic Foundation, Cleveland, OH TO: NORELIUS.C,E. Div of Engineering, R3 .

- I SSUED: 820812 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FFAC: 8209150259A '

TASK: ODID: DIN- 820812 DPN: DRN: ,

DOCKET NO: 03000394 FICHE: 14884 344 14GG4 346 RIDS:

E312200284 Responds to NRC 031129 Itr te violations noted in IE insp of License 34-OO466-01. Corrective actions. personnel informed ,

that hot labs in nuclear medicine 5 cardiology depts must be surveyed on weekly basis.

TROM: ARON.S J. Cleveland Clinic Foundation, Cleveland, OH ,

TO: GRENIAWSKI D.J. Region 3 (Post 820201)

I SSUED: U31205 AVAIL: PDR 1p- DOCUMENT TYPE: CLINC FPAC: 83122OO270A T ASK: OD1D: DIN: 831205 DPN: DRN:

DOCKET NO: 03002649 FICHE; 21575 350 21575 350 RIDS:

8312290379 Responds to NRC 831202 Itr te violations noted in IE insp

-of License 34-03749-10. Corrective actions: program of-daily GM surveys L wipe tests -instituted L records of daily p constancy checks meintained. ~

FROM: WIESEN,E.J. MetrcHealth Medica 1' Center, Cleveland, OH (formerly Cle TO: SRENIAWSKI,D.J. Region 3 (Post 820201)

ISSUED: 831213 AVAIL. PDR 9pp. DOCUMENT TYPE: CLINC FFAC: 6312290369A TASK: ODID: DIN- 831213 DPN: DRN:

DOCKET NO: 03000410 03013873 FICHE: 2166: 232 21661- 240 RIDS:

0410300142 "Rept of Radiation Gurvey of AECL Theratron 80 Co-60 Unit ;

After Relocation of Unit to Room G-105 in Delgreve D1dq, "

< FROM: WIESEN,E. MetroHealth Medical Cent'r, e Cleveland, OH (formerly Cle TO:

I SSUED: 840520 AVAIL: - PDR 10pp. DOCUMENT TYPE: TETR FPAC: 04103OO106DA

- TASK; ODID: 17740 DIN: TR-840520 DPNi DRN:

DOCKET NO: 03000410 FICHE: 27104 171 27184 180. R IDS:

=

1..-..-- __...~.-.-;--_--._...-...---_.,._._,_._u_...--..-.-.__.--.-- ,-,. ..-

l 4

l G/20/92 PAGE 4 O. S NUCLEAR REGULATORY COMMISSION DCS PART!AL RECORD FORMAT REPORT l

l 0409130471 Application for amend to License 34-00466-01, naming SJ Aron I radiation safety officer & requesting possession of Gd-153 for human use. Documentation re SJ Aron qualifications e n c 1.

Fee paid.

FROM; ARON,G.J. Cleveland Clinic Foundation, Cleveland, OH ;

TO: Region 3 (Post 820201) e ISSUED: 840619 AVAIL: PDR 14pp. DOCUMENT TYPE; TLAMDL FPAC: 8409130467D ;

TASK: OD!D: 77040 DIN: AMUL-040619 DPN: DRN:

DOCKET NO. 03002649 FICHE: 26465 069 26465 002 RIDS: l 0410300137 Forwards radiation survey results of AECL Theratron 80 1 Co-60 unit after relocation of unit in b1dg.

FROM' WRIOHT-DAY,E. MetroHealth Medical Center, Cleveland, OH (formerly Cle <

TO; VACCA,P.C. Materials Licensing-Dranch ;

I SSUE D: 040622 AVAIL: PDR 1 p p. DOCUMENT TYPE: CLINC FPAC: G4103OO106D T ASK: ODID: 17740 DIN: 840622 DPN DRN:

DOCKET NO- 03000410 FICHE: 27164 170 27184 200 RIDS:

8410310066 Application for amends to Licenses 04-00466-02,34-00466-03, 34-00466-04 & SNM-1659, authorizing SJ Aron as radiation safety officer. Fee paid.

FROM; ARON.S.J. Clevelend Clinac Foundation, Cleveland, OH TO: Materiels Licensang Branch ISSUED. 040010 AVAIL: PDR 26pp. DOCUMENT TYPE: TLAMBL FPAC: 8410310046D TASK: ODID: 77295 DIN: AMDL-840810 DPN; DRN:

DOCKET NO' 03000394 07002213 03014577 F1CHE' 27D28 129 27228 154 R1DS:

8410300115 Submits info re results of radiation survey of Co-oO teletherapy unit,in response to Nhc 040020 request.

FROM: WR IGHT- DAY, E. MetroHealth Medical Center, Cleveland, OH (formerly Cle TO: ADAM,W.J. Region 3 (rost 020201)

ISSUED; E40907 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8410300106D TASK: 0D10: DIN: 840907 DPN: DRN:

DOCKET NO:- 03000410. FICHE: 27194 167 27184 167 RIDS:

T 04120bO770 Forwards addl inf o re 840619fapplication to amend License 34-OO466-01,in response to 640816 request, FROM: ARON,S.J. Cleveland Clinit Foundation. Clevelend, OH TO: HDLT,D.J. _ Materials Licensing Dranch ISSUED: -840924 AVAIL: PDR 7pp. DOCUMENT TYPE: CLINC- FPAC: 0412050764D TASK: ODID: 77040 DIN: 840924 DPN: DRN:

DDCKET NO: 03002649 FICHE: 27779 216 27779 222 RIDS!

l

- y=,....y. ., ..e,, -

w, ym_,_,..- ,-,.y,-.,,,y.,,._,,,,,p.-ye,,.w,E.y,.,.mm,., ..y- -

i

. 0/20/92 PACE 5 U. S. NUCLEAR REGULATORY COMMISSION :

DCS PARTIAL RECORD FORMAT REPORT j 0500210510 Application for renewal of License 34-03749-07, authorizing use of 6,000 C1 Co-60 in AECL Theratron 80 for human use.

Related info enc 1, FROM: WRIGHT-DAY,E. MetroHealth Medical Center, Cleveland, OH (formerly Cle '!

TO:

3 ISSUED: 041126 AVAIL: PDR 10pp. DOCUMENT TYPE: TLAMBL FPAC: 8508210493C i TASK: ODID: 77876 DIN AMDL-841126 DPN: DRN:

DOCKET NO- 03000410 FICHE: 32321 015 32321 046 RIDS:

0503000227 " Teletherapy Survey Rept Following Co-60 Source Replacement Five Yr Insp & Servicing for Cleveland Clinic Foundation AECL Model 700 Teletherapy Unit."

FROM: ARON S.J. Cleveland Clinic Foundation, Cleveland. OH TO:

ISSUED: 041210 AVAIL: PDR 16pp. DOCUMENT TYPE: TR2AR FPAC: 8503080203DA

TASK: ODID: 77966 DIN' ZAR-841210 DPN: DRN; DOCKET NO: 03000394 F1CHE: 29284 345 29284 360 RIDS:

6503080216 Forwards teletherapy survey rept,per Conditions 18-20 of License 34-00466-02 I

FROM: ARON.S.J. Cleveland Citntc Foundation, Cleveland, OH TO: Regton 3 (Post 820201)

ISSUED: 041214 AVAIL- PDR 1p, DOCUMENT TYPE: CLINC FPAC: 85030DO203C TASK: ODID: 77966 DIN: 041214 DPN: DRN: >

DOCKET NO: 03000394 FICHE' 29284 343 29284 343 RIDS:

8503080221 Forwards tel e thorapy survey rept,per Conditions 18-20 of i License 34-00466-02.

'I FROM: ARON.S J. C3eveland Clinic Foundation, Cleveland. CMi ,

TO: Materials Licensing Dranch ISSUED; 841214 AVAIL: P r>R 1 p. DOCUMENT TYPE- CLINC FFAC- 8503080203D T ASK; ODID 184B4 DIN- 841214 DPN: DRN:

DOCKET NO- 03000394 FICHE: 29284 344 29284 344 RIDS:

8506110192 Discusses R Field' credentials in using radioactive sources.

R Field considered competent tn handling sources -

FROM: THOMAS F;J. Cleveland C11nte Foundation, Cleveland, OH TO; MATSON,E. Region 3 (Post 820201)

ISSUED: 850109 AVAIL: PDR 1p, DOCUMENT TYPE: CLINC FPAC: 850611015GG

' TASK: ODID: DIN: 850109 DPN: .DRN:

DOCKET-NO: 03000427 FICHE: 30832 231 30032 231 RIDS:

t

-.,,..-,n --.,.-,-,--,,--,,--.--,n , , ~ - , .-sv -,,~,,-.-.,n_~---,,-,-n,_,n-_,n-,,.nn,-,- <~w,--n.,~w-w-.

. - - - . - - .-_.-._ __.-_._ - -_.~._- ---- .-----

U/20/92 PAGE 6 U. S NUCLEAR REGULATORY COMMISSION I

DCS PARTIAL HFCORD FORMAT REPORT .

I B506120%3 Notifies that R rield completed res2dency in radiation oncology in June 1904. Competency in handling radioactive sources, including Ir-192,C5-137,Au-198 6 P-22,erhabited during previous 4 yr s.

FROM: THOMAS F.J. Cleveland Clinic Foundation, Cleveland, OH TO: MATSON,E. Region 3 (Pott e20201>

I SSUED: 850109 AVAIL- PDR 1p DOCUMENT TYPE: CLINC FPAC: 85061205100 TASK: ODID: 77732 DIN: 850109-01 DPN: DRN:

DOCKET NO- 03000523 FICHE 30858 125 30858 125 - RIDS:

8612O20575 Forwards application for renewal of License 34-OO466-01. Tee paid. ,

FROM: ARON S J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post G20201) -

ISSUED- 850110 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 8612O20477H TASK: ODID: 7816C DIN: 650118 DPN: DRN: -

DOCKET NO. 03002649 FICHE: 38785 117 30705 270 RIDS:

8612O20583 Applicat2cn for renewal of L i c e n t. e 34-OO466-01,outhorizing use of any byproduct matl w/ Atomic Nun.ber-s 3 through 83, ,

inclusive 6 any matl listed in Groups 1-VI of Schedule A to 10CFR35.100, l FROM: HARTWELL S.W. Cleveland Clinic Foundation, Cleveland, OH-TO: ,

I SSUED: 800118 AVAIL. PDR 153pp DDCUMENT TYPE' TLAMBL FPAC: 8612O20477HA

.T ASK: ODID: DIN. AMBL-050118 DPN: DRN:

DOCKET NO 03002649 FICHE: 30785 119 3878b 270 RIDS.

8503000211 Subm2ts addl info re 241210 teletherapy survey rept,in response to DSO121 re,uust. Individual continuously present.

for one yr would not eaceed 500 mrem limit, Record of D50121 telcon e n c 1.

FROM: ARON,5 J. Cleveland Clinic Foundation, Cleveland, OH TO :. ADAM D. Gegion 3 (Post G20201)

IGSUED: 850123 AVAIL- PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 85030GO203D TASK: ODID: 77966 DIN: 850123 DPN: .DRN:

DOCKET NO: 03000394 FICHE: 29284 341 29284 342 RIDS:

86120POS60 Amended applicetabn Pos Tentwal of License 34-00466-01,

-authorirang use of Ir-192 sealed source teeds encased in nylon r2bbon L designating.JP Satton L JR L i t t l e .a s n.enib e r s of medical isotope comn,1ttee memberc.

TROM: ARON S.J. Cl evel and' Cl a n a c- F ounda ti ren. Cleveland,-OH-TO: Region 3.(Post 820201)

ISSUED: 850205 AVAIL: PDR 12pp, DOCUMENT TYPE: - TLAMBL 'FPAC: 8612O20477F TASK: ODID: 78168 DIN' AMBL-850205 DPN: DRN:

DOCKET NO: 03002649 FICHE- 38785 104 38785 115 RIDS:

i 1

,,-r .en,,, - . - e-.-,.....-,,.-..-- , ~ . , - - -,----.+m ---e., ,- + - . - ~ - , . --n - - , , m,

OMlO/92 PAGE 7 U. S, NdCLEAR REGt'LATORY COMMISSION DCS PAR 11AL RECD 4D iORMAT DEPORT O'2061101G7 Heenamines 050226 telcun re R Field.R Field considered qualtfled for use of andt:ated isotopes FROM: THOMAS,f.J. Cleveland Clinic Foundation, Cleveland, OH TO- MATSON,E. Region 3 (Post 820201)

ISSUED: 850226 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8506110158F TASK: ODID: 77732 DIN- 8$0226 DPN: DRN:

DOCKET NO. 03000427 FICHE: 30832 230 30832 230 RIDS-G306120D49 Discusses qualifstations of R rield in response to 850226 telcon.R fields was resident at foundation for 4 yrs in radiation therapy dept f4 c onsider ed qualified to use isotopes h Co-60 telether-apy unit.

FROM: THOMAS,F J Cleveland Clantt Foundat1on, Cleveland, OH TO: MATSON.E Region 3 (Port 020201)

ISSUED. OSO226 AVAIL: PDR 1p. DOCUMENT TYPE- CLINC TPAC: BSO6120B10F T ASK: ODID 77732 DIN B50226-01 DPN: DRN:

DOCKET NO 03008523 FICHE 3005R 124 30050 124 RIDS:

8504300316 App 1ieation for a rr e n d to L2 cense 34-03749-10, authorizing use of two H-3 electron c ap tur e detectors o u r c e Lab-500-3,each containing 130 mC1 H-3,300 mci total F ROtt DUCH5DAUM,P. MetroHealth Medical Center, Cleveland, OH (formerly Cle T O.

ISSUED D50307 AVAIL PDR 1p DOCUMENT TYPE TLAMDL FPAC: 85043OO304D T ASK: ODID 70469 DIN AMUL-850307 DP N: DRN:

DOCKET ND 030133/3 FICHE' 30060 317 30068 317 RIDS:

6511270107 Notiftes of n e us addre.s to ensure delivery to correct location wtthin foundat2on FROM ARON,5 J. Cleveland Clinic Foundation, Cleveland, OH TO: STANOCURY T R NRC - No Detailed Affiliation Given I SSUF D: 650924 AVAIL PDR 1p DOCUMENT TYPE- CLINC FPAC: OS11270184A TASK: OD I D. 79941 DIN 850924 DPN: DRN:

DOCKET NO- 03000J94 03002649 03017931 FICHE- 33646 103 33646 103 RIDS:

860131003S Addresses tump12ance w / tF C T equirements. Records show thet preparation L inject 2on ateat surveyed weekly using low range,end w 1 r .i o m survey meter.Di gt-arig wipe test turvey not completed for Last Half 1985 due to manpower thertage FROM: ARON 5 J Cleveland Clinic Foundation. Cleveland, OH TO: WIEDEMAtt D G. R :s g 2 o n 3 (Post 200201)

ISSUED 060107 AVAIL PDR 7pp DOCUMENT TYPE: CLINC FPAC: 8601310035*

T ASK: ODID: DIN: 860107 DPN: DRN:

DOCKET NO ' 03002649 FICHE' 34426 313 34426 320 RIDS: IEO7D

i 0/20/92 PAGE U \

I U U. NUCLEAR REGULATORY COMMICSION DCS PARTIAL RECORD TORMAT HLPORT ,

l 0604030351 App

cation for amend to Licente 34-OO466-01,outhortring disposal of St-90 sealed source previously used as beta eye app 1trator 6 It-192 seeds.in lead shielding containers. Fee !

peld. !

FROM; ARON.S J Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Fost 820201)

IGSUED: 06010B AVAIL: PDR 3pp. DOCUMENT TYPE: TLANDL FPAC; 0604030349A T ASK: OD1D: 00467 DIN: AMDL-860100 DPN: DRN:

DOCKET NO: 03002649 FICHE- 35400 166 35409 169 R1DS:

8004150312 Informs of results of survoys prior to & after move of hot lab & equipment.No radiation above background found during surveys. Area released for unrestricted use.

THOM: W1EBEN.E.J MutroHealth Medical Center, Cleveland, OH (formerly Cle ;

TO: Region 3 (Post 020201)

ISSUED: 060311 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FPAC: OBO41SO290E T ASK; OD1D. DIN

D60311 DPN: DRN:

45195 ODS RIDS:

DOCKET NO' 03013073 FICHE. 45195 053 8004150307 rorwards applicat2on for amend to license 34-03749-10, correcting name to Cleveland Metropolitan General Hosp 6 changing vendor supplying personnel monitoring devices to siemens Gammasonic,Inc.

FROM: UUCHSDAUM,P. MetroHealth Medical Center, Cleveland. OH (formerly Cle TO: Region 3 (Post 620201)

ISSUED: 860313 AVAIL; PDR 2pp. DOCUMENT TYPE: CLINC FPAC:-8G04150290D TASK: 0D1 D: DIN: 860313 DPN: DRN:

DOCKET NO: 03013073 FICHE. 45195.030 45195 052 RIDS:

3804150309 Application for emend to Licente 34-03749-!O,authoraring-listed amounts. cf Gr oup s 1-V1 matis,mutit listed an 10CFR31=11.1-131,P-32 Au-198-1-131.b Ye-133 in sealed sources for gas chromatography b instrument calibt.

FROM: BUCHDDAUM,P. MettoHealth Medital Centeri Cleveland, OH,(formerly_Cle TO:

I SSUED: 060313 AVAIL: PDR 13pp. DOCUMENT T YPE : TLAMDL FPAC: OBO4100290DA T ASK: OD 1 D - DIN. AMDL-860313 DPN: DRN:

DDCKET-NO- 03013873 F1CHE- 4519S 040 45195 052 RIDS: -

G6073OO225 _ Application for amend to License-32-00466-01, incorporating I changes in isotope committee membership b revs to 060107 info re esposure rate & contamination: survey data Supporting I documentation' encl Fee paid, .

FROM: ARON,9 J. -Cleveland-Clinic Foundation, Cleveland, OH l TO; . Region 3 (Post 820201).

-!GSUED: 860429 AVAIL: PDR 4pp. DOCUMENT TYPE: TLAMDL FPAC: 86073OO220A TASK: ODID: 0125G DIN: AMDL-G60429 DPN: DRN:

DOCKET-NO: 03002649 FICHE: 37312 000 37312 003 RIDS:

w w er er ---=w-.--eas ere-s-*we-em----w,- w--g--%-sr-.cm-,, mire-- u wre ew, _ ._www.weewww,,~,-,,,,- r, ,---w,--myw-wr,*g,-.my- eir - =- r. a m y ye--g-e-er,w--,g y - ,r n 2y v .e- --

-_- - - - - - = - - _ - . - . . . ~ - . - . -- ._ _ - . _ . - . -

O/20/92 PAGE 9 U. B. NUCLEAR REGULATORY COMMISSION !

DCS PARTIAL RECORD FORMAT REPORT

-D004150350 Application for ametid to License 34-03749-10, edding l 1 possession F, use of SO 901 H-3 for cancer research. l I

l FROM; BUCHSDAUM,P, Me tt oHeal t h Medical Center. Cleveland, OH (fotmerly Cle TO: Region 3 (Post 820201)

ISSUED: 060D05 AVAIL: PDR 5pp. DOCUMENT TYPE: TLAMDL FPAC: 88041SO290L TASK: ODID: 01373 DIN: AMDL-060505 DPN: DRN: i DOCKET NO: 03013073 FICHE: 45195 206 45193 210 RIDS:

8610030362 Application to amend License 34-OO466-04 authorizing use of max 1,200 C1 CS-137 in AECL-RCC Gammacell-1000-blood irradiator,Model A,for irradiation of blood, blood components ,

& biological samples & matts. Fee paid. !

TROM: ARON,B.J. Cleveland Clinic Foundation. Cleveland, OH ;

TO: Region 3 (Post G20201)

ISSUED: 060523 AVAIL: PDR 3pp. DOCUMENT TYPE: TLANDL FPAC: 06100303378 TASK: ODID: 01431 DIN. AMDL-060523 DPN: DRN:

DOCKET NO. 03017931 FICHE: -39079 316 38079 310 RIDS:

8702260624 Application for renewal of License SNM-16D9, author 12ing use ,

of Pu-238 for implantation in humans 65 component of 4

nuclear-powered cardiac pacemakers.

FROM: -ARON S J Cleveland Clinic Foundation, Cleveland, OH l TO: Region 3 (Post 820201)

ISSUED: 860709 AVAIL: PDR 2pp. DOCUMENT TYPE: TLASNM FPAC: 8702260593C TASK: ODID. 81679 DIN. ASNM-860709 DPN: DRN: -

DOCKET NO. 07002213 FICHE- 39757 293 397S7 309 RIDS:

8702260610 Forward 5 11 sting of phy5ic:an5, Including qualificat2ons 4, associated info. involved an facility pacemaker progrem Info part of application for renewal of License SNM-16D9,per 860709 ltr FROM: ARON.S.J. Cleveland Clinic F o u n d a t i o n ,- Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 860730 AVAIL: PDR 4p p. DOCUMENT TYPE: CLINC FPAC: 8702260593D TASK: ODI D: 81679 DIN: 860730 DPN: DRN:

DOCKET NO: 07002213 FICHE' 39757 289 39757 292 RIDS:

8612O20011 Responds to 860805 Itr. Thirty-day ettension until end of Aug granted,per 060729 telcon m/W Adam.

'FROM: ARON,5 J. Cleveland _ Clinic Foundation. . Cleveland, OH TO: VACHERLON,P Region 3 (Post 820201) l ISSUED: 860008 AVAIL: PDR 1p. DOCUMENT TYPE: 'CLINC FPAC: 8612O20477C

.TASX: ODID: 70168 DIN: 860008 DPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 090 30705 098 RIDS:

l i

i

- - - - .-. - _ - . ~

0/20/92 PAGE 10-U. G NUCLEAR REGULATORY COMMIGSION DCS PARTIAL RECORD FORMAT REPORT 0612O20490 Responds to G60701 request for aod) inic re License 34-OO466-01.A11 therapy doses of liquid 1~131 opened inside nuc l ear thed i c ine dept radiation fume hood by personnel wearing gloves.

FROM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: ADAM,W.J. Region 3 (Post 020201)

, ISSUED: 860813 AVAIL: PDR 5pp. DOCUMENT TYPE: CLINC FPAC: 8612O20477D 1 T ASK: ODID: 78160 DIN: 860813 DPN: DRN:

DOCKET NO- 03002649 FICHE: 3G785 093 38785 097 RIDS:

0610100270 FO!A request for NRC rept dealing w/ incident at Univ of Wisconsin re use of Ir-192 radiation sources for implantation in pigs.

FROM: ARON S J. Cleveland Clinit Foundation, Cleveland, OH-TO: GRIMSLEY,D. Office of Administration (Pre 870413)

I SSUED: 060923 AVAILo PDR 10 DOCUMENT TYPE: CLINC FPAC: G610100270 TASK: ODID: DIN' D60923 DPN; DRN:

DOCKET NO: F1CHE' 38206 286 38206 286 RIDS:

420721026'S Informs of misadministration of radiopharms Patient incorrectly administered 250 uC1 Tc-99m for renel scan instead of 12 mC1 Tc-99m DTPA. Caused by failure to make i

positive identification of radiopharm.

FROM: ARON,S J Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 861007 AVAIL: PDR 1p. DOCUMENT TYPE. CLINC FPAC: 9207150106A T ASK: ODID: DIN: 661007-01 DPN: DR N -

DOCKET NO. FICHE- 62546 037 62546 037 RIDS:

9206240233 Provides rept of therapeutit misadministration involving use of clinical Co-60 source cor.cerning license 34-00466-02.

FROM. THOMAS.F J. Cleveland Clinic Foundation. Cleveland, OH TO: W1EDEMAN D. Region 3 (Post 820201)

I SSUED: G61120 AVAIL: PDR 1 p. DOCUMENT TYPE: CLINC FPAC; 9206100321A TASK- ODID: DIN: G61128-01 DPN: DRN:

DOCKET NO- 03000394 FICHE- 62105 070 6210b 078 RIDS.

0612310200 Resubmitted FOIA request for info on loss of Ir-192 sealed sources-implanted in pigs at Univ of Wisconsin.

FROM: ARON,G Jf Cleveland Clinic Foundation, Cleveland, OH.

TO: GRIMSLEY,D,H. Division of Rules & Record. (Pre 870413)

ISSUED: 061211 AVAIL PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8612310288 TASK: ODID: DIN: 061211 DPN: DRN:

DOCKET NO. FICHE: 39131 049 39131 049 RIDS:

,. --c.-....-...-,..,_....-.~_ _ . _ , . . _ . _ . . , - _ _ . _ . _ . . . . _ __..- . _ _

D/20/92 PAGE 11 U G. NUCLEAR HEGULATORY COMMIGS!DN DCS PARTI AL RECORD FORMAT REPORT SD01050274 Applicetson.for art.end to Licente 34-00466-04, authoriting use of AECL Cs-137 1rradiator.Enct survey results show less than

.005 uti leakage activity Inservice instruction / training will precced use.

TROM: ARON.B J. Cleveland Clinic Foundation, Cleveland, OH TO: WHISTON,P.J. Region 3 (Post 820201)

ISSUED: 861217 AVAIL: PDR 2pp. DOCUMENT TYPE: TLAMBL TPAC: -0SO1050256A

~

T ASK: ODID: 82604 DIN: AMDL-861217 DPN: DRN:

DOCKET NO: 03017931 FICHE: 43913 137 43913 138 RIDS:

0702030195 Responds to 661120 confirmatory action itr re Co-60 misadministration reported on 061117. Summary of 10CFR35.42 prepared & method of reporting within institution reafftrmed.

FROM: THOMAS,F.J. Cleveland Clinic Foundation, Cleveland, OH

, TO: KEPPLER,J.G. Region 3 (Post 920201) j ISSUED: 861210 AVAIL: POR 10pp. DOCUMENT TYPE: CLINC FPAC: 8702050171A TASK: ODID: CAL DIN: 061218 DPN: DRN:

DOCKET NO: 03000394 03002649 FICHE: 39512 322 39512 339 RIDS:

9207210279 Informs of mitadministr ation of radiopharms Patient injected w/Tc-99m sodium pertechnetate rather than Tc-9 h DTPA Caused by technologist error.On 861118, dose infiltrated through closed peripheral line. Lines rechecked

- T R Orl: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH i

TO: Region 3 (Post 820201)

ISSUED: 870100 AVAIL: PDR 3pp DOCUMENT TYPE: CLINC FPAC: 92071bO10BA

-TASK: OD I D. DIN' B70109-01 DPN; DRN:

DOCKET NO. 03000394 F I CHE: 62546 038 62546 040 R1DS:

GG01110110 Application for amends to Licenses 34-00466-02 &

34-OO466-03 authcr1 ring use of licensed matl by P Higgins, C 51bata,W McCarthy,J Blue & W Roberts for--nonhuman use 6 SJ Aron as radiation saf ety officer.ree paid, TROM: ARON,5 J, Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 070115 AVAIL: PDR 23pp. DOCUMENT TYPE- TLAMDL FFAC: 89011101048.

TASK: OD1D; 02815 DIN: AMDL-070115 DP N: DRN:

DOCKET NO: 03000394 03014577 FICHE: 43971 223 43971 245 RIDS:

0801110404 Application for amend to License 34-00466-01, author 2 ring )

relocation of nucicar medicine !, nuclear cardiology depts per attached drauilng Fee paid.

FROM: ARON, S.- J. Cleveland Clinic Foundataon, Cleveland, OH-TO: Region 3 (Post 820201) _

ISSUED: 870204 AVAIL: _PDR 6pp, DOCUMENT TYPE: TLAMDL FPAC: 8801110371A TASK: ODI D: 82925 DIN: AMBL-870204 - DPN: DRN:

DOCKET NO: 03000394 FICHE: 43990 108 43990 194' RIDS:

8/20/92 -PAOC 12 U. S, NUCLEAR REGULATORY COMMISSION DCS PAR 11 AL RECORD FORMAT REPORT 8704220187 For ward s rad 14tton safety incident rept te release of radioactive ashes from incinerator room, reported on 870206.

Loss of Itcensed matl does not appear to be - substantial hatord to perbons in unrestricted areas, FROM: ARON.S J. Cleveland Clinic Foundation, Cleveland, OH TO. W1EDEMAN,D. Region 3 (Post 820201)

ISSUED: 070212 AVAIL: PDR 3pp. DOCUMENT TYPE: CLINC FDAC: 8704220130D TASK: ODID: DIN: 870212 DPN: DRN:

DOCKET NO: 03000394 03002649 03D14577 F1CHE: 40620 143 40620 145 R1DS:

0704220166 Responds to 870126 I t r, ano d i f i e d by 070304 enforcement _

conference Licensee offers to amend Licenses 34-00466-01, 34-00466-02 6 34-00466-03 to include enc 1 OA/OC statement of principios for dept of radiation therapy.

FROM: KISER,W G. Cleveland Clinic Foundation, Cleveland, OH TO: HIND,J.A. Region 3 (Post 820201)

ISSULD: 070313 AVAIL- PDR 7pp DOCUMENT TYPE: CLINC FPAC: 8704220130C TASK: OD 10: DIN' 870313 DPN; DRN:

-DOCKET-NO. 03000394 03002649 03014577 FICHE: 40620 136- 40620 142 RIDS:

3904150298 Responds to requett for addl info re application for 1enewal-of License 34-03749-10 Proceduret used to grant permits to use radioactive matis not changed since 780601 6 0927 submittals.

FROM: W1ESEN.E J MetroHealth Medical C entet . Cleveland. OH (formerly Cle TO: WHISTON.P.J Region 3 (Post 820201)

ISSUED: 870409 AVAIL: PDR 20pp DOCUMENT TYPE' CLINC FFAC: 8804150290D TASK: OD 1 D: 76364 DIN. 670409 DPN: DRN:

DOCKET NO - 03013873 FICHE: 45195 016 45195 035 RIDS:

6001120199 Application for amend to License 34-OO466-01, authorizing use of Siemens bone mineral densitometer Related info enc 1.

Fee paid-FROM: ARON.S J. Cleveland Citnic Foundation. Cleveland, OH TO: MCCANN,G.M. Region 3 (Post 820201)

ISSUED. 870409 AVAIL PDR 13 p p - DOCUMENT TYPE: TLAMBL FPAC: 8801120185D TASK: OD1D: 83518 DIN- AMBL-870429 DPN: DRN; DOCKET NO- 03002649 FICHE

43998 183- 43998 196 RIDS; 8801120192 Forwards addl info to be included w/870407 application for amend to License 34-OO466-01. Limit for I-125 should be increased to 1,000 mCt.

FROM: ARON.S.J, Cleveland-Clinar Foundation. Cleveland, OH TO: MCCANN,G,M. . -Region 3 (Post 820201)

ISSUED: 870508 AVAIL: PDR 10pp. DOCUMENT TYPE: CLINC FPAC: 8801120185C TASK: ODID: 83518 DIN: 870508 DPN: DRN:

. DOCKET NO: 03002649 F ICHE: 43998 173 43998 182 RIDS:

i I

_ _ . - . _ . - - . - ~ . _ - - - - - - - - - _ _ - - . - - ~ _ . - . - - - .. . . -

i

)

8/20/92 PAGE 13 U. S. NUCLE AR RFGUL ATC ~ Y COMMISSION j

(

DCS PARTIAL RECORD FORMAT REPOR1 :

i 8801120109 Application for amend to License 34-00466-01, permitting ,

radiation safety officer to determine number of clauses ;

j personnot muqt attend for basic radiation safety seminar ,

series. ;

FROM: ARON,S.d Cleveland Clinic Foundation, Cleveland, OH ;

TO: MCCANN,G. Region 3 (Post 820201)

ISSUED: 870513 AVAIL: PDR 1p. DOCUMENT TYPE: TLAMDL FPAC: 8801120185D -

TASK: ODID: 83518 DIN: AMDL-870513 DPN; DRN:

DOCKET NO: 03002649 FICHE: 43990 172 43998 172 RIDS:

8705260306 Responds to 87041D notice of violation & proposed imposition of civil penalty from insp on 061120-870210- Corrective ac tions: tec hn t e n1 staff meeting held on 061205 to advise of 24 h notification b other NRC requirements.

. FROM: KISER,W S. Cleveland Clinic Foundatton, Cleveland, OH ;

TO: NRC -

No Detailed Affiliation Given :

ISSUED: 870514 AVAIL: PDR Spp. DOCUMENT TYPE: CLINC FPAC: 8705260306-TASK: OD1D: EA-87-042 DIN: 870514 DPN: .DRN:

DOCKET NO: 03000394 FICHE: 4103G 305 41038 309 RIDS: IE14D-I 8801260563 Application for amend to License 34-OO466-01, changing.

membership of radioisotope 5 radiation safety committees as listed Fee paid.

FROM: ARON,S.d Cleveland C1inar Foundation. Cleveland,-OH TO: Region 3 (Post B20201)

ISSUED: 870716 AVAIL: PDR 1p. DOCUMENT TYPE- TLAMDL FPAC: 8801260059A i TASK: ODID- 83967 DIN- AMBL-370716 DPN: DRN:

DOCKET NO 03002649 F1CHE. 44125 113 44125 113 RIDS:

i 8601280204 Requests.that Item 9 to license, ass 2gning one source for use in.AECL Theratron 780 teletherapy unit 1s another source.for 1 replacement,be. included w/870115 appitcation for amend to license.per 870728 t elc on. Record of 870728 telcon enc 1.

FROM: ARON,S,d Cleveland Clinic Foundationi ' Cleveland, OH TO: WHISTON,P. Regaan 3 _(Post 820201)

ISSUED: 870728 AVA1L PDR 2pp. DOCUMENT TYPE- CLINC FPAC: 8801280166A TASKt 0D10: 82816 DIN: 870728 DP N: DRN:

DOCKET NO: 03000394 F ICHE : 44167'077 44167 -103 RIDS:

8902140427 Forwards,- "Rept Following Source Change to AECL Theratron 80 Co-60 Teletherapy Unit."

FROM: SKUDIC,S E. MetroHealth Medical Center, Cleveland,- OH (formerly Cle TO: Region 3-(Post 820201)

I SSUED: 870720 AVAIL: PDR 17pp; DOCUMENT TYPE: CLINC FPAC: '0902140418A TASK: ODID: 83926 DIN- 870728 DPN: DRN:

DOCKET NO: 03000410 FICHE: 48729 264 48729 280 RIDS:-

4 U/20/92 PAGE 14 U. S. NUCLEAR REOULATORY COMMISSION DCS PARTIAL HECORD FORMAT REPORT {

0910100329 Application for amend to License 34-OO466-01, authorizing J MacIntyre as senior consultant & estabitshing stated .

quorum. i FROM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: MALLETT,D.S, Regiors 3 (Post B20001)

ISSUED: 070812 AVAIL: PDR 160pp. DOCUMENT TYPE: TLAMBL F PAC: 0910180257A >

TASK: ODID: 04067 DIN: AMDL 070812 DPN: . DRN: ;

DOCKET NO 03002649 FICHE: 51524 287 51525 006 RIDS:

, 0807060200 Application for amend to Ltcense 34-03749-10, increasing ;

possession limits of I-125 & H-3 to 60 mCf each. j FROM. W1ESEN,E. MetroHealth Medical Center, Cleveland, OH (formerly Cle TO: WH1910N, P J_ Hegion 3 (Fost 820201) '

ISSUED: 870827 AVAIL: PDR 1p. DOCUMENT TYPE: TLAMDL FPAC: OD07060277A '

. TASK: ODID. C4114 DIN: AMDL-870627 DPN: DRN:

DOCMET NO: 03013873 FICHE: 46003 235 46003 235 RIDS:

9207210300 Informs of 970820 misadministration,of radiopharm Patient received O 56 mci Tc-99m instrument calibt source labeled "Not for Human Uso " Caused by personnel error Techno1cgit,t cautioned to recheck labels oefore injecting, FROM; ARON.S J Cleveland Clinic Foundation. Clevelsnd, OH TO: Office of Nuclear Material Sa f e t y t< Saf eguard s ISSUED: 870903 AVAIL: PDR 3pp. DOCUMENT TYPE. CLINC FPAC: 920715010BA TASK: ODID DIN: 870903 DPN: DRN: i DOCKET NO- 03017931 FICHE 62046 041 62546.043 RIDS: {

0902130042 Application for amend to License 34-03749-10, raising possession limit for P-32 to 60 mCt.

FROM: WIESEN,E= MetroHealth Medical Center, Cleveland, OH (formerly Cle TO: WHISTON,P.J. Region 3 (Post 820201)

ISSUED: 871021 AVAIL: PDR 1p. DOCUMENT TYPE: TLAMUL FPAC: 890213OO35C TASK: ODID: 84356 DIN; AMBL-871021 DPN: DRN:

DOCKET NO: 03013873 FICHE: 48720 062- 48720 062 RIDS:

8807180103 Application for omend to Licenst- 34-OO466-04, authorizing needed maint of JL Shepherd Cs-137 1rradsator by clinic personnel. Fee paid.

FROM: ARON,S.J. Cleveland-Clinic Foundation. Cleveland, OH TO:

ISSUED: 871022 AVAIL: PDR 17pp. DOCUMENT TYPE: TLAMBL FPAC: 8807180092C TASK: ODID: 84360 DIN: AMBL-871022 DPN: DRN:

DOCKET NO: 03017931 FICHE: 46199 273 46199 287 RIDS: ,

l

-._._..-.-._.-.-.--_-.__._._w.-.-.__. . . . . , - . - _ - - - . . . . _ . - . - . , . , . - .

O/20/92 PAGE 1F V S, NUCLEAR REGULATORY COMMISSION l

DCS PARTIAL RECORD FORMAT REPORT i

l i

8902140131 Application for amend to License 34-OO466-01,authertring use of 500 mC1 H-3 k I-121 & 300 mC1 Cr-bl. Fee paid, FROM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUE D: 871130 AVAIL: PDR 8pp DOCUMENT TYPE: TLAMBL FPAC: 89021401228 :

TASK: ODID: 384563 DIN: AMDL-871130 DPN: DRN:

DOCKET NO; 03002649 FICHE: 48730 119 48730 126 RIDS: ,

8902130038 Forwards addl procedures to be followed when using F-32 by l any principal users. ,

TROM: WIESEN,E. MetroHealth Medical Center, Cleveland, OH (formerly Cle r TO: Region 3 (Post 820201)

ISSUED: 871222 AVAIL: PDR 3pp, DOCUMENT TYPE: CLINC FPAC: 890213OO35A TASK: ODID: 84336 DIN: 871222 DPN: DRN:

DOCKET NO: 03013873 FICHE: 48728 057 48728 059 RIDS- 1 8903030286 Application for a me r. d to License 34-03749-10, authoriring increase in postossion of S-3S to 40 mC1 from 20 mC1. .

FROM: W!ESEN,E MeticHealth Medical Center, Cleveland, OH (formerly Cle TO: WHISTON,P.J. Region 3 (Post 820201)

ISSUED: 080107 AVAIL PDR 1p. DOCUMENT TYPE: TLAMDL FPAC;. 0903030284A TASK: ODID D4716 DIN' AMBL-880107 DPN: DRN:

DOCKET NO. 03013G73 FICHE 49016 195 49016 195 RIDS:

8807100100 Provides clarifications to 871022 application for-amend to License 34-00466-04,per 800222 telton, q

FROM: ARON.S;J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED. 680229 AVAIL- PDR - 3p p. DOCUMENT TYPE: CLINC FFAC: 88071000920 TASK: DDID. 84360 DIN: 680229 DPN: DRN:

DOCKET NO: 03017931 r!CHE: 46199 270 -46199 272 RIDS:

8904050516 Application for amend to License 34-OO466-01,authoriting l

. listed individuals as radioisotope 1, radiation safety

" committee. Fee paid.

~

FROM: ARON,S J. Cleveland. Clinic Foundation. Clevelend, OH .

TO; -Region 3 (P9st G20201)

ISSUED: 000314 AVAIL: PDR 2pp. DOCUMENT TYPE: TLAMBL FPAC: 8904050513A TASK: ODID: 85047- DIN: AMDL-880314 DPN;. _ DRN:

DOCKET NO: 03002649- FICHE: 49399 135 49399 136 RIDS:

- _ . _ . - _ _ _ . _ _ _ ~.-_ _ _ __ _-__.._ ___-__.,_.._._..... ,__ _ __ _ _

G/20/92 PAGE 16 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 9911230370 Submits addl info, including partially deleted radiation safety committee repts,re two c ases of possible

! mi sadmini st ra tions of Co-60 teletherapy Info submitted per 800330 telton request, FROM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: W1EDEMAN,D. Region 3 (Post 820201)

ISSUED: 880418 AVAIL. PDR 43pp. DOCUMENT TYPE: CLINC FPAC: 8811230354AA TASK: ODID: DIN: 880418 DPN: DRN:

DOCKET NO: 03000394 FICHE. 47652 173 47652 224 RIDS:

9207210316 Informs of 880517 misadministration of radiopharm, Patient injected w/11.3 mC1 Tc-99m DTPA for renal scan. Caused by !

misunderstanding of referring physician request & not checking requisition. Personnel reprimanded.

FROM: ARON,5.J. Cleveland Clinic Foundation, Cleveland, OH TO: .W1EDEMAN,D. Region 3 (Post 820201)

ISSUED' B00320 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9207150108A >

TASK-- DDID: DIN. 680520-01 DPN: DRN:

DOCKET NO' 03002649 FICHE: 62546 044 62546 045 RIDS:

F 4207230063 Informs. of 680524 misadministration of radiopharm. Patient injected w/ 611 mC1 Tc-04-99 instead of 12 mci Tc-99m DTPA for renal scan. Caused by personnel telectsng wrong syringe from dotage cart. Personnel reinstructed FROM: ARON.S.J. Cleveland C12nic Foundation, Cleveland, OH F O .- W1EDEMAN.D. Region 3 (Post 820201).

I SSUED: D80c13 AVAIL PDR 2pp DOCUMENT TYPE: CLINC FPAC: 920715010BA '

T ASK: ODID: DIN: G80613-01 DPN: DRN:

DOCKET NO- 03014577 FICHE: 62546 047 62546 048 RIDS:

U905080323 Application for amend to License 34-03749-10, authorizing pussession limit of P-32 to be increased to 125 mci from 75 mC1 & adding listed names to radiation safety committee.

FROM: WILSEN,E.J. MetroHealth Medital Center, Cleveland OH (formerly Cle TO: Rogson 3-(Post 820201)

I SSUED: 890707 AVAIL: PDR 3pp DOCUMENT TYPE: TLAMDL'FPAC: 8905080321A TASK: OD1D. 85731 DIN

AMDL-880707 DPN: DRN; >

DOCKET NO 03013D73 F I CHE: 49683 089 49683 091 R IDS:

9207230114 Informs of G80721 misadministration of radiopharm. Patient injected w/20 mci Tc-0 instead of Tc-99m MDP. Caused by I failure to read label & selection of wrong syringe. Personnel reinstructed.

FROM: ARON,S J. Cleveland Clinic Founda tion, Cleveland,: OH -

. TO: WlEDEMAN,D. Region 3 (Post 820201)~

ISSUED: 880728 AVAIL: POR 2pp. DOCUMENT TYPE: CLINC1 FPAC: 9207150108A

-TASK: ODID: DIN: 880728-01 DPN: DRN:

DDCKET NO: 03002649 F ICHE: 62546 049 62546 050 RIDS;

.-.,_.-....,,,.....,,__._-,_......-._.-_-_;,_._-.--..~-_.,a.-.__.. -- __, ~ . . . _ . _ _ _ _ - -

-__._.____.m ..-._

8/20/92 PAGE 17 U. S. NUCLEAR RECULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT i i

8906290379 Requests clattfication of 24 h rule per 10CFR35.33(a) for !

misadministrations,per 090309 telcon re NRC 090223 notice of f i violation <

l FHOM: ARON,S.J. Cleveland Clinic Foundation, Cleveland, OH TO: W1EDEMAN,D. Region 3 (Post 820201) E ISSUED: 690315 AVAIL. PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8906290376A TASK: ODID: DIN: 890315 DPN: DRN: .

DOCKET NO: 03000394 FICHE; 50377 295 50377 295 RIDS:

8910250234 Responds to violations noted in insp of License 34-03749-10 on 890621. Corrective actions noted all peckages received inspected for external contamination b nuclear medicine ;

technologists will be given addl training.

FROM: W1ESEN,E.J. MetroHealth Medical Center, Cleveland, OH (formerly Cle _;

10: MCELROY,N L Region 3 (Post 820201)

ISSUED: 090815 AVAIL: PDR- 2pp. DOCUMENT TYPE: CLINC FPAC: 8910250234 TASK: ODI D: DIN: 890815 DPN: DRN: ,

DOCKET ND: 03013873 FICHE: 51623 097 51623 098 RIDS: IEO7D -

8910260074 Responds to violations noted in insp of License 34-03749-07 on 890621. Corrective actions: Survey meters calibt, form ,

showing all known survey meters in hosp & required calibt date established & procedures revised, FROM: W1ESEN.E.J. MettoHealth Medical Center, Cleveland, OH (formerly Cle ;

TO: MCELROY,N.L. Regton 3 (Post 820201) .

ISSUED: 090815 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 8910260074 TASK: ODID- DIN; 890815-01 DPN: DRN:

DOCKET NO. 03000410 FICHE- 51636 163 51636 164 RIDS: IEO7D 92061RO367 Informs of 900102 matedminastration of-radiopharm Patient given 092 1-131 capsule for uptake & scan instred of 015 ;

I-131 capsule for uptake & trestment.Coriective actions reviewed & retraining provided, Withheld.

FROM:

Cleveland Clinic Foundation. Cleveland, OH TO: NRC - No Detailed Affiliation Given

, I SSUED: 900405 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC .FPAC: 9206180321A

-T ASK. ODID: DIN: 900405' DPN- DRN:

DOCKET NO. 03002649 F ICHE: -62105 075 62105 076 RIDS:

9206160355 Responds to 900404 telcon request te investigation of anonymous allegations concerning potential diagnostic >

misadministration at facility on 900104. Corrective actions taken & explained in enc 1. f FROM: ARON,S.J. Cleveland Clinic-Foundatlon, Cleveland, OH TO: MATSON,E.R. Region 3 (Post 820201)

ISSUED: 900406 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FFAC: 9206180321A ,

TASK: ODID: DIN: 900406 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62105 073 62105 074 RIDS:

i 4 I 1

i e.-,,v n ,.- :- n ,- , - n. .u,,,.,,,,,,.., ,,.n.n,,,,,,,,,n-, ,_.n.,m ,.~en- ,,n_-,,,,,--,.m, - . . - . , . -

_m_ m.-__..____.____.______ _

l r

0/20/92 PAGE 10 U. S. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT ;

t 9009070203 Application for amend to License 34-OO466-01,authoriring !

change in committee membership for J McCall replacing D U1 reich as nursing representative, ,

FROM: ARON S.J, Cleveland Clinic Foundation, Cleveland, OH !

TO: Region 3 (Post 820201) ;

ISSUED: 900604 AVAIL: PDR 4pp. DOCUMENT TYPE: TLANDL FPAC: 9009070204A

'l TASK: ODID- DIN: AMDL-900604 DPN: DRN:

DOCKET NO: 03002649 FICHE: 55135 225 55135 228 RIDS:

9009070199 Submits action plan for GA program of dept of radiation therapy,ab promised during licensee 900502 visit to NRC.

Entire GA program will be reviewed semiannually by oft of .

quality mgt, l

- FROM: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: MALLETT,D.S. Region 3 (Pust 820201)

ISSUED: 900625 AVAIL: PDR 7p p. DOCUMENT TYPE: CLINC FPAC: 9009070199 i TASK: ODID: DIN: 900625 DPN: DRN; ;

DOCKET NO. 03002649 FICHE: 55132 353 55132 355.R!DS: IEO7D ;

9103190354 Submits action plan for QA program of dept of radiation >

3 therapy approved by ofc of quality mqt Entire GA program reviewed semiannually, FROM: KEYS,T.F. C1sveland Clinic Foundation, Clevtiend, OH TO: MALLETT,D.S. Region 3 (Post 820201) ;

ISSUED: 900625 AVAIL; PDR 13pp DOCUMENT TYPE- CLINC FPAC: 9103190263B TASK, ODID: DIN: 900625-01 DPN: DRN.

DOCKET NO: 03000394 FICHE: 57090 000 57090 092 R1DS:

9007260020 Responds to NRC 900621 notice of violation te insp of ,

Licenses 34-00466-01 L 34-00466-02 L forwards payment of ,

civil penalty.

+

FROM: LOOP,F.D. Cleveland Clinic Foundation, Cleveland, OH TO: Ofc o+ Enforcement (Post 870413)

I SSUED; 900719 AVAIL: PDR 4p p. DOCUMENT TYPE: CLINC FPAC: 9007260020 ,

TASK: ODID: EA-90-074 DIN: 900719- DPN: DRNf ,

DOCKET NO. 03002649 03000394 F ICHE: 54722 314 54722 317 RIDS: IEO7D 9009070204 Responds to radiation safety insp findings in NRC 900522 ltr; Corrective actions: nuclear medicine policy te possible ;

~

mi$ administration revised.

FROM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH~

TO: PANKRATZ,R.M. Region 3 (Post G20201)

ISSUED: 900719 ' AVAIL: PDR 12pp. DOCUMENT TYPE: CLINC FPAC: 9009070204* '

TASK: ' ODID: DIN: 900719. DPN: DRN:

DOCKET NO: 03002649 -FICHE: 55135 213 55135 228 RIDS: IEO7D t

M.-r .- vv--,r- -m~.,,.....~-,-.ww.r-, , - . _ ,

. __.._ _ _ __-_._ ._m _ ..._ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _

1 O/20/92 PAGE 19 NUCLEAR REGULATORY COMMISSION U. S.

DCS PARTI AL RECORD FORMAT REPORT t

9207230127 Informs of 900021 misadministration of radiopharm Patient !

given 1 mC1 Tc-99m sulfor colloid instead of S mC1 Tc-99m f disofenin. Caused by personnel misunderstand 1ng physicians request. Personnel reprimanded. !

FROM: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post 020201) l ISSUED. 900823 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC TPAC: 9207150100A '

TASK: ODID: DIN- 900823-01 DPN: DRN:. ;

- DOCKET NO: 03002649 FICHE: 62546 051 62546 002 RIDS: i 9012030080 Forwards addl 2nfo re action plan for GA program,per 900625 l tr. 1 i

FROM: REYS.T.F. Cleveland Clinir Foundation, Cleveland, OH TO: MATSON,E.R. Region 3 (Post 820201)

ISSUED: 900420 AVAIL PDR 1 p. DOCUMENT TYPE: CLINC FPAC: - 901203OO78A .

TASK: ODID. DIN: 900928 DPN: DRN:

DOCKET ND: 03002649 00000394 F I C HE : 55909 151 55989 154 RIDS:

- 9207230133 Informs of 901109 misadministration of radiopharm Patient injected w/10.3 mci Tc-99m DTPA. Caused by personnel error, FROM: ARON,S.J. Cleveland C11nte Foundation, Cleveland, OH TO: MATSON,E. Region 3 (Post 820201)

I SSUED : 901119 AVAIL: PDR 2pp DOCUMENT TYPE: CLINC FFAC: 92071SO108A ;

TASK: ODID: DIN: 901119-01 DPN: DRN:

DOCKET NO. 03002649 FICHE: 62346 053 62546 OS4 RIDS:

9103190269 Responds to 901126 Itr requesting follow-up assestment of effectiveness of improved communicationo at CleVe16nd Clinsc Foundation.

FROM: KEYS,T F. Cleveland Citnic Foundation, Cleveland, OH TO: DAVIS,A.D. Region 3 (Post 820201) '

ISSUED: 901210 AVAIL; PDR . 3pp. DOCUMENT TYPE. CLINC FFAC: 9103190263A TASK: ODID'. EA-90-074 DIN: 901218 DPN: DRN; DOCKET NO: 03000394 FICHE: 57090 077 S7090 079 RIDS:

9207230141 Informs of 910211 misadmanistration of radiopharm Patient given 015 mC1 INa!-131 instead o f- 10 mC2 INa]-131 Imaging Technologist misunderstood physicians request Signed worksheet will be attached to pick 2sotope request.

FROM: ARON S.J. Cleveland Clinic-Foundation, Cleveland, OH TO: Region 3 (Post 820201) _

ISSUED: 910218 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC .FPACi-92071SO108A TASK; ODID: DIN: 910218-01 DPN: DRN:

- DOCKET NO: -03002649 FICHE: 62546 OSS 62546 056 RIDS:

}

.. .- - . . . , ,n , , ,,nn,, , nv---- ,.,n -,n..n.,.,,,,,,-n-_,-,.-,,,,_---,-----... . . , _ . . . - - - . . - , - - , , . . ~ < .

. - _ _ _ _ . _ - . - . - . - - - . - _ _ . - . _ . - - - =- _.-.- -

8/20/92 PAOL 20 V 5. NUCLE AR REGULATORY COMMISSION' DCS PARTIAL RECORD FORMAT REPORT 9207230204 Informs of 910412 misadministration of radiopharm. Employee received extremity esposure during 1st quarter of 1991.

Caused by use of position emitting radioisotopes for care j of nuclear medicine patients.

FROM: ARON,5.J. Cleveland Clinic Foundation. Cleveland, OH TO: SIMMONS,T. Region 3 (Post 820201)

ISSUED: 910415 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9207150108A l TASK: ODID: DIN: 910415-01 DPN: DRN:

DOCKET NO: 03002649 FICHE. 62546 057 62S46 050 RIDS:

9207230208 Informs of 910414 misadministration of radiopharm. Dose I

miscalulation for endobronchial application discovered.

Incorrect calculation form put in practice in 1988. Physicist ;

responsible never revised forms !4 left dept.

FROM. ARON,S J Cleveland Clinic Foundation, Cleveland, OH TO: SIMMONS,T. Region 3 (Post 820201)

ISSUED: 910426 AVAIL: PDR Spp. DOCUMENT TYPE: CLINC FPAC: 9207150108A -,

T ASK: ODID: DIN: 910426-01 DPM: DRN:

DOCKET NO: 03002649 FICHE: 62546 OS9 62546 063 RIDS:

9105160070 Comment opposing proposed rules 10CFF71,170 4. 171. "Rev of d "

Fee Schedules,100% Fee Recovery -l FROM: GO, R. T. Cleveland Clinic Foundation. Cleveland. OH ?

TO: Office of the Secretary of the Commission I SSUED: 910509 AVAIL- PDR 2pp. DOCUMENT TYFE TTPC FPAC: 9105160070 TASK; ODID: 36FH14870 00297 DIN: 56FR14S70 00297 DPN: DRN:

DOCKET NO' FICHE: 57720 167 S7720 168 RIDS: DSIOD 9107090220 Responds to confirmatory action Itr of 910521 Corrective actions:all new members of all labs using radioisotopes will be instructed in proper bandling t,use of matis L proper response in case of radioactive spill FROM: ARON.S.J. Cleveland Clinic Foundation, . Cleveland. OH-TO: DAVIS,A.B. Region 3 (Post 820201)

ISSUED: 910612 AVAIL: PDR- lipp. DOCUMENT TYPE: CLINC FPAC. 9107080204B TASK: ODID: CAL DIN: 910612 DPN; DRN:

DOCKET NO: 03002649 F I CHE: 58389 204 58389 214 RIDS:

9107080215 Addresses specific issues re use of radioactive matls in las of PL Fox concerning confirmatory action Itr dtd 910521 FROM: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: DAVIS A.B. Region 3 (Post 820201)

ISSUED: 910620 AVAIL: PDR 3pp. DOCUMENT TYPE: 'CLINC FPAC: 9107080204A TASK: ODID: CAL DIN: 910620 DPN: -

DRN:

DOCKET NO: ~O3002649 FICHE: 58389 201 58389 203' RIDS:

. ._.._m._ _ . - . _ . _ . - _ . - . . _ _ . _ . _ _ . ~ _ . . _ . . _ _ - _ _ _. . _ , , _ . ~ . . . , - - _ _ _

U/du/Yd t' Alit M1 U. S. NUCLEAR REGULATORY COMMISSION j DCS PARTIAL RECORD FDPMAT REPORT 9207230267 Informs of 910629 masadministration of radiupharm. Wrong patient given 21.2 mci Tc-99m MDP instead of 10.0 mC1 Tc-99m Mag-3. Caused by Technologist error. Procedures implemented for verification of patient identification.

FRON: ARON.S.J. Cleveland Clinic Foundation, Cleveland, OH TO: Region 3 (Post B20201) '

I SSUED: 910702 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9207150108A T ASK: ODID: DIN. 910702-01 DPN: DRN: <

DDCKET t=D: 03000394 FICHE: 62546 067 62546 068 RIDS:

9207230231 Informs of 910727 misadministration of radiopharm. Patient

, given 30 mC1 Tc-99m PYP for lung vent study instead of 30 mC1 DTPA Reconstituted wrong reagent kit. Implemented new proceduros for labeling & handling. t FROM:

Cleveland Clinic Foundation. Cleveland, OH ;

TO: Region 3 (Post 820201) ,

ISSUED: 910729 AVAIL: PDR 1p, DOCUMENT TYPE: CLINC FFAC: 9207150108A TASK: ODID: DIN- 910729-02 DPN: DRN:

DOCKET NO; 03002649 FICHE: 62546 065 62546 065 RIDS:

92072302b7 Informs of 910728 misadmins,tratson of radiopharm. Patient given 30 mci Tc-99m PYP for lung vent study instead of 30 mC1 DTPA.Reconstitued wrong reagent kit. Implemented new procedures for labeling b handling.

FROM:

Cleveland C1snic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 910729 AVAIL: PDR 10 DOCUMENT TYPE. CLINC FPAC: 9207150108A '

TASK: ODID: DIN 910729-03 DPN: DRN:

DOCKET NO- 03002649 FICHE: 6254e 066 62546 066 RIDS: ,

9207230215 Forwards two repts of m25 administration of radiopharms on 910727 h 20 FROM: SAHA,G. Cleveland Citnic Foundation, Cleveland, OH TO: Region 3 (Post 820201)

ISSUED: 910731 AVAIL: PDP 'I p. DOCUMENT TYPE: CLINC - FPAC: 9207150108A TASK: ODID. DIN. 910731-01 DPN: DRN:

DOCKET NO: 03002649 FICHE: 62546 064 62546 064 RIDS:

9109050328 Forwards interim radiation safety plan.h requests extension of current broad license to completely rewrite license.

- FROM: KEYS.T F- Clevelahd Clinic Foundationa Cleveland, OH TO: GRODE.J, Region 3 (Post 820201)-

ISSUED: 910016 AVAIL: .PDR 4pp. DOCUMENT TYPE: CLINC FP AC: 9109050328

' TASK:

- DDID: DIN: 910816 DPN: DRN:

DOCKET ND: . 03002649 FICHE: 59029~175 59029 178 RIDS: IEO7D

,-,v, y,- r%~ yrrm r ,. -y a ~,r.s ,-,--.r.- -

e f - .m m , . , ,y-- .r-m [

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l 6/20/92 PAGE 22 l U. S NUCLEAR REGULATORY COMMISSION l

DCS PARTIAL RECORD FORMAT REPORT l

l 9109050131 Responds to notice of violation dtd 910729 re License !

34-OO466-01. Corrective ac tions: research workers instructed l to perform personal & area surveys to evaluate suspected exposure. !

FROM: LOOP.F.D. Cleveland Clinic Foundation, Cleveland, OH i TO: Ofc of Enforcement (Post 870413)

ISSUED: 910829 A/ AIL: PDR 17pp. DOCUMENT TYPE: CLINC FPAC: 91090SO131 TASK: ODID. EA-91-084 DIN: 910029 DPN: ~DRN:

DOCKET NO 03002649 FICHE: 59171 222 S9171 238 RIDS: IE14D 9110010201 Responds to NRC 910729 itr te violations noted in insp of lic ense 34-OO466-01. Correc tive ac tions: report ing requirements outlined in 10CFR20,403 will be re-emphastred &

structured course in radiation safety will be offered.

FROM. LOOP,F D. Cleveland Clinic Foundation. Cleveland, OH TO: Document Control Dranch (Document Control Desk)

ISSUED: 910924 AVAIL PDR 4pp. DOCUMENT TYPE: CLINC FPAC: 9110010281 TASK: ODID: EA-91-OS4 DIN; 910924 DPN: DRN:

DOCKET NO: 03002649 FICHE S9263 330 59263 333 RIDS: 1E14D i 9112310026 Submits myt essessment of First monthly rept from consvitant per compliance w/ license condition FROM: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: GRODE.J Region 3 (Post 820001) 4 ISSUED: 911014 AVAIL: PDR 12pp. DOCUMENT TYPE. CLINC FPAC: 9112310021D T ASK: ODID: DIN. 911014 . DPN: DRN:

DOCKET NO 03002649 FICHE: 60130 094 60130 10S RIDS:

9112310024 Submits mgt assessment cf second monthly rept in compliance ,

w/ license condition.

FROM: KEYS,T.F. Cleveland Clinic Foundation, Cleveland, OH TO: GROBE,J. Region 3 (Post 820201)

ISSUED: 911115 AVAIL: _PDR 18pp. DOCUMENT TYPE: CLINC FPAC: 9112310021A TASK: ODID: DIN: 911115-01 DPN: DRN:

DOCKET'NO' 03002649 T !C HE: 60130 076- 60130 093 RIDS:

9203160230 Requests background info on F Miraldi L_ involvement in misadministration issue which occurred in Jan 1992. ,

FROM: KEYES.T.F. Clevelsnd Clinic Foundation- Cleveland, OH TO: GRODE,J. Region 3 (Post 820201)- _ .

ISSUED: 920302 AVAIL: PDR -1p. DOCUMENT TYPE: CLINC FPAC: 9203160194B TASK: ODID' DIN: 92O302 DPN: = DRN:

DOCKET NO: 03002649 F ICHE: 60911 326 60911-327 RIDS:

2 y ,e <= -- er -+r.-w -e. e.r--,,--r-, m--- , r w -.-- r r --m m n n -n , n ,- x,--,- -,=,.,-o-n-<, -,~ - , - - - - - - , - + - - -,-. ,- - -. - - ,

. . - - - - . - . . - - - . . . - . - . . - _ _ ~ - . - . . - .. . . . . . .- ,

G/20/92 PAGE 23 U. G. NUCLEAR REGULATORY COMMISSION DCS PARTIAL RECORD FORMAT REPORT 920$190188 Responds to NRC 920326 Itr te violations noted in insp rept 30-02649/92-01 on 920128-29, Corrective ac tions: two radiation therapy technologists: received complete review of appropriate storige h and l ing, ver i fi c at i on E< procedt e s. ]

FROM: . KEYS.T.F. Cleveland Clinic Foundation, .leveland, OH i TO; SCHULT7,W.H. Region 3 (Post 820201) ~

ISSUED; 920417 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPACi 9205190182A_ I

- T ASK: ODID: DIN: 920417 DPN: DRN: ;

DOCKER NO 03002649 FICHE: 61706-149 61706 150 RIDS: l l

l i

i 1

L I .

f f

l .. ,..m,

. . - -- . - . . ~ . - . ~ . - ..-... _ _-.- . - _ - . - . - . - . . - . ~ . . - -

-*m. ++% v.4 --ee;-. +mps., g ,&.] 4 , > m. ...g ,,,rm a g .4Ae ,

U.S.-NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8409130467 Amend 28 to License 34-00466-01 for Cleveland Clinic Foundation,nami:4g SJ Aron as radiation safety officer.

FROM: HOLT,B.J. AFFIL: NE R3 TO: AFFIL: ,

ISSUED: 840816 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8409130467*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 26465 065 26465 082 RIDS: ML308410310046 Amend 16 to License 34-00466-02 for Cleveland Clinic Foundation, authorizing SJ Aron as radiation safety officer.

FROM: HOLT,B.J. AFFIL: NE R3 ,

TC: AFFIL:

SUED: 840822 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8410310046*

'ASK: ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE:-27228 126 27228 154 RIDS: ML308410310098 Amend 2 to License SNM-1659 for Cleveland Clinic, authorizing SJ Aron as radiation safety officer.

FROM: HOLT,B.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 840827 AVAIL: PDR 1p. DOCUMENT TYPE: TLLSNM FPAC: 8410310098#

TASK: ODID: SNM-1659 A 02 DIN: DPN: DRN:

DOCKET NO: 07002213 FICHE: 27228 108 27228 122 RIDS: ML30

~mwwau.aua,Gasdu.naac.uW "

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8410310270 Amend 2 to License 34-00466-04 for Cleveland Clinic Foundation, changing Condition 12 re radiation safety officer.

FROM: HOLT,B.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 840822 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8410310270#

TASK: ODID: 34-00466-04 DIN: DPN: DRN:

DOCKET NO: 03017931 FICHE: 27226 303 27226 317 RIDS: ML308410310288 Amend 6 to License 34-00466-03 for Cleveland Clinic Foundation, changing Condition 12 re authorized users of matl.

FROM: HOLT,B.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 840822 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8410310288#

TASK: ODID: 34-00466-03 DIN: DPN: DRN:

DOCKET NO: 03014577 FICHE: 27226 318 27226 332 RIDS: ML308412050764 Amend 29 to License 34-00466-01 for Cleveland Clinic Foundation, authorizing use of 3 Ci Gd-153 in Lunar Radiation Corp spine scanner,Model DP3,for bone mineral analysis of human lumbar spine.

FROM: HOLT,B.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 841023 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 8412050764*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 27779 212 27779 222 RIDS: ML30

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8503080203 Amend 17 to License 34-00466-02 for Cleveland Clinic Foundation, amending Condition 25 re-possession & use of licensed matl.

FROM: ADAM,W.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 850212 AVAIL: PDR_ 1p. DOCUMENT TYPE: TLLMBL FPAC: 8503080203*

TASK: ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 29284 338 29284 338 RIDS: ML308503080227 " Teletherapy Survey Rept Following Co-60 Source Replacement Five Yr Insp & Servicing for Cleveland Clinic Foundation AECL Model 780 Teletherapy Unit."

FROM: ARON,S.J. AFFIL: EMDCLEV TO: AFFIL:

ISSUED: 841210 AVAIL: PDR 16pp. DOCUMENT TYPE: TRZAR FPAC: 8503080203DA TASK: ODID: 77966 DIN: DPN; DRN:

DOCKET NO: 03000394 FICHE: 29284 345 29284 360 RIDS:

18511270184 -Amend 3 to License 34-00466-04 for Cleveland Clinic-Foundation, changing address.

FROM: MATSON,E.R. AFFIL: NE R3 TO: AFFIL:

ISSUED: '851105 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8511270184*

TASK: ODID: '34-00466-04 DIN: DPN: DRN:

DOCKET NO: 03017931 FICHE: 33646 102 33646 103 RIDS: ML30 d

- ' 4. . . , , , ,.-r -,

g,

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8511270191 Amend 30 to License 34-00466-01 for Cleveland Clinic Foundation, changing address.

FROM: ADAM,W.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 851105 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC:- 8511270191# -

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 33646 303 33646 304 RIDS: ML308511270194 Amend 3 to License SNM-1659 for Cleveland Clinic Foundation, changing address.

FROM: MATSON,E.R. AFFIL: NE R3 TO: AFFIL:

-ISSUED: 851105--AVAIL: PDR 1p. DOCUMENT TYPE: TLLSNM FPAC: 8511270194#

TASK: ODID: SNM-1659 A 03 DIN: DPN: DRN:

DOCFET NO: 07002213 FICHE: 33646 301 33646 302 RIDS: ML30 851'1270195 Amend 18 to License 34-00466-02 for Cleveland Clinic-Foundation, changing address.

FROM: MATSON,E.R. AFFIL: NE R3 TO: AFFIL:

ISSUED: -851105 AVAIL: PDR 1p. - DOCUMENT TYPE: TLLMBL FPAC: '8511270195#

TASK: 'ODID: 34-00466-02 DIN: DPN: DRN:

RIDS: ML30

_ DOCKET NO: 03000394 FICHE: 33646.299 33646 300 l

.... , w U.S. NUCLEAR REGULATORY COMMISSION NUDOCS L PARTIAL- RECORD FORMAT REPORT 8604030349 Amend 31 to License 34-00466-01 for_ Cleveland Clinic Foundation, amending Subitems 6K,7K & 8K to authorize use of 3 Ci Gd-153 in Lunar GD series sealed source.

FROM: MCCANN,G.M. AFFIL: NE R3 TO: AFFIL:

ISSUED: 860128 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8604030349*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 35400 165 35400 169 RIDS: ML308607300220 Amend 32 to License 34-00466-01 for Cleveland Clinic Foundation, amending Condition 23 re conduct of licensed-matls program.

FROM: MCDONALD,C.F. AFFIL: NE R3-TO: AFFIL:

ISSUED: 860527 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8607300220*-

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 37312 079 37312 083 RIDS: 'ML308610030337 Amend 4 to License 34-00466-04 for Cleveland Clinic Foundation, authorizing use of max 720-Ci Cs-137 sealed sources in AECL Gamma Cell 1000 A irradiator-for irradiation-of-blood & biological samples & matls.

"FROM: WHISTON,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 860722 AVAIL: PDR. Ip. DOCUMENT TYPE: TLLMBL FPAC: 8610030337*-

TASK: ODID: 34-00466-04 DIN: DPN: DRNi DOCKET NO: 03017931 FICHE: 38079 312 38079 315 . RIDS: ML30

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8612020477 Amend 33 to License 34-00466-01 for Cleveland Clinic Foundation, amending license in entirety.

FROM: ADAM,W.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 860910 AVAIL: PDR 6pp. DOCUMENT TYPE: TLLMBL FPAC: 8612020477*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 086 38785 270 RIDS: ML308702250339 Forwards notice of 870304 significant licensee meeting w/ Cleveland Clinic Foundation in Glen Ellyn,IL to discuss violations identified during recent insp, corrective actions

& enforcement options available,per 870218 telcon.

FROM: HIND,J.A. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV ISSUED: 870219 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: -8702250339A~

TASK: ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET No: 03000394 FICHE: 62105 088 62105 089 RIDS: IE07 8702260593 License SNM-1971 for Cleveland Clinic Foundation, authorizing implantation of Pu-238 in humans as component of nuclear-powered cardiac pacemakers.

FROM: MCCANN,G.M. AFFIL: NE R3 TO: AFFIL:

ISSUED: 861021 AVAIL: PDR 2pp. DCCUMENT TYPE: TLLSNM FPAC: 8702260593*

TASK: ODID: SNM-1971 DIN: DPN: DRN:

DOCKET NO: 07003044 FICHE: '39757 285 39757 328 RIDS: ML30

- % a u w w.u a & a n w - %d ~ ~ \

I l

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 1

8702260650 Informs that Cleveland Clinic selected to participate in i Model C-101 clinical investigation program.

FROM: COOKSTON,S. AFFIL: EMVCORAT TO: VACCA,P.C. AFFIL: NOMC ISSUED: 760426 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 8702260593F 1 TASK: ODID: 0704 DIN: DPN: DRN:

DOCKET NO: 07002213 FICHE: 39757 317 39757 317 RIDS:

8704290276 " Cleveland Clinic Foundation Radiation Therapy Misadministration Investigative Rept."

FROM: A LMON D , P . AFFIL: EEIULOU TO: AFFIL:

ISSUED: 870207 AVAIL: PDR 35pp. DOCUMENT TYPE: TRZAR FPAC: 8704290199BC TASK: ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 40732 062 40732 097 RIDS:

8710230172 Partially withheld memo forwarding write-ups on Cleveland Clinic, Toledo Hosp & St Luke Memorial Hosp proposed Aos,per recipient 870130 memo.Show cause order to Highland Waterford Medical Sycs not considered AO.

FROM: DAVIS,A.B. AFFIL: NE R3 TO: HELTEMES,C.J. AFFIL: NEXD ISSUED: 870309 AVAIL: PDR 24pp. DOCUMENT TYPE: CMMEMO FPAC: 8710230148A TASK: ODID: DIN: DPN: DRN:

DOCKET NO: FICHE: 43175 090 43175 113 RIDS:

i I

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7

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U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT

-8801050256 Amend 5 to License 34-00466-04 for Cleveland Clinic Foundation, amending Condition 18 re conduct of program.

FROM: MCCANN,G.M. AFFIL: NE R3 TO: AFFIL:

ISSUED: 870617 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC:- 8801050256*--

TASK: ODID: 34-00466-04 DIN: DPN: DRN:

DOCKET NO: 03017931 FICHE: 43913 136 43913 138 RIDS: ML308801110104 Amend 8 to License 34-00466-03 for Cleveland Clinic Foundation, amending Condition 12 authorizing WK Roberts, JW (-

Blue,P Higgins,C Sibata or.W McCarthy to use licensed matls

& SJ Aron as radiation protection officer.

FROM: WHISTON,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 870730 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8801110104*

TASK: ODID: 34-00466-03 DIN: OPN: DRN:

DOCKET NO: 03014577 FICHE: 43971 220 43971 245 RIDS: ML308801110371 Voids Cleveland Clinic Foundation application under. Control Number 82925 due to combination w/ application under Control Number 83518.

FROM: MALLETT,B. AFFIL: NE R3 TO:

AFFIL: NIRDFAL .

ISSUED: 870717 AVAIL: PDR 1p. DOCUMENT TYPE: CMMEMO FPAC: 8801110371*

-TASK: ODID: 82925 DIN:- DPN:- . DRN:

DOCKET.NO: 03000394 FICHE: 43990 187 43990 194 RIDS: ML30 y*e-g = = - -w+-ev. y - , ,e e ,m - v se e---t w,v ti- i++-ette,---wwar--- ur e-e--ww -ses*e=tr=s-e+ -,- - s e + w- r-e eine

dw , w w+ s + v s+==--sme-+w--tvd

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8801120185 Amend 35 to License 34-00466-01 for Cleveland-Clinic Foundation, authorizing use of 800 mci I-125 in Osteon Inc ,

Model SPHAXXX bone mineral analyzer.

FROM: MALLETT,B.S. AFFIL: NE R3 TO: AFFIL:

ISSUED: 870717 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 8801120185*

TASK: ODID: 34-00466-01 DIN: DPN:. DRN:

DOCKET NO: 03002649 FICHE: 43998 168 43998 196 RIDS: ML308801260559 Amend 36 to License 34-00466-01 for Cleveland Clinic Foundation, changing Condition 16 re conduct of program.

FROM: MADERA,J.R. AFFIL: NE R3 TO: AFFIL:

ISSUED: 870803 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8801260559*-

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 44125 112 44125 113 RIDS: ML308801280166 Amend 20 to License 34-00466-02 for Cleveland Clinic Foundaton, changing Item 9.A that authorizes one source for use jn tletherapy unit & another for replacement purposes &

Conditio 12 that names supervisors for licensed matl use.

PROM: WHISION,P.J. AFFIL: NE R3 LTO: AFFIL:

ISSUED: 870810 AVAIL: PDR 1p. DOCUMENT TYPE: TLLMBL'FPAC: 8801280166*

TASK: ODID: 34-00466-02 DIN: - DPN: DRN:-

DOCKET NO: 03000394 FICHE: 44167 076 44167 103 RIDS: ML30

+ -- a w

- -ew U.S. NUCLEAR REGULATORY COMMIS3 ION NUDOCS PARTIAL RECORD FORMAT REPORT L8807180092 Amend 6 to License 34-00466-04 for Cleveland Clinic Foundation, changing Condition 18 re conduct of program.

FROM: MCCANN,G.M. AFFIL: NE R3 TO: AFFIL:

ISSUED: 880328 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 8807180092*

TASK: ODID: 34-00466-04 DIN: DPN: DRN:

DOCKET NO: 03017931 FICHE: 46199 266 46199 287 RIDS: ML308811230361 Insp Rept 30-00394/88-01 on 880811.One of two allegations unresolved. Major areas inspected: allegations re possible teletherapy misadministrations at unidentified medical institution & Cleveland Clinic Foundation.

FROM: BURGIN,R.E. AFFIL: NE R3 TO: AFFIL:

ISSUED: 881115 AVAIL: PDR 9pp. DOCUMENT TYPE: TIINSP FPAC; AR11230354A

' TASK: ODID: 30-00394/88-01 DIN: DPN: DRN:

DOCKET-NO: 03000394 FICHE: 47652 164 47652 224 RIDS:

8902140122 Amend 37 to License 34-00466-01-for Cleveland Clinic-Foundation, authorizing use of 500 mci H-3 &~500 mci I-125.

FROM: MATSON,E.R. AFFIL: NE R3 TO: AFFIL:

ISSUED: 880310 AVAIL: PDR '1p . DOCUMENT TYPE: TLLMBL FPAC: 8902140122*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 48730 114 48730 126 RIDS: ML30 4

U.S. NUCLEAR REGULATORY COMMISSION -

NUDOCS PARTIAL RECORD FORMAT REPORT

'8903030498' Notice of-violation from insp on 880811. Violation noted:

misadministration-of radiopharm occurred in Aug 1985 &

licensee did not rept event until 880408.

FROM: DAVIS,A.B. AFFIL: NE R3 TO: AFFIL: '

ISSUED: 890223 AVAIL: PDR- 1p. DOCUMENT TYPE: TINVID FPAC: - 9203060423A TASK: ODID: 30-00394/88-01 DIN: DPN:- DRN:

DOCKET NO: 03000394 FICHE: 60899 126 60899 126 RIDS:

8904050513 Amend 38 to License 34-004'66-01 for Cleveland Clinic Foundation, authorizing use of listed licensed matl.

FROM: WHISTON,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 880407 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 8904050513*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649-FICHE: 49399 133 49399 136 RIDS: ML308910180257 Amend 43 to License 34-00466-01 for Cleveland Clinic Foundation, amending Condition 16.to state that-license based on licenses statements & representations in 870812

, ltr.Related info, including 870812 ltr, encl.

FROM: PELKE,P.J. AFFIL: NE R3' TO: AFFIL:

. ISSUED: 890310 AVAIL:-PDR 1p. DOCUMENT TYPE: TLLMBL FPAC: 8910180257*

1 TASK: ODID:-34-00466 DIN: DPN:- DRN:

DOCKET NO: 03002649 FICHE: 51524 285 51525 086 RIDS;.ML30 T k- v- t a- n e-m-srw- r e--- e- - -v- r-isr = %.

~~ - - ~ - ~ - - - - -

waahw.uaa iua. mas - P' U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9003130061 Matls licensing package for Amend 41 to License 34-00466-01 for Cleveland Clinic Foundation. Control:83789.

FROM: PELKE , P.J . AFFIL: NE R3 TO: AFFIL:

ISSUED: 890113 AVAIL: PDR 8pp. DOCUMENT TYPE: TLLMBL FPAC: 9203060423A -

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 60899 056 60899 064 RIDS: ML309003130760 Matls licensing package for Amend 12 to License 34-00466-03 for Cleveland Clinic Foundation. Control:386208.

FROM: MATSON,E.R. AFFIL: NE R3 TO: AFFIL:

ISSUED: 890127 AVAIL: PDR 108pp. DOCUMENT TYPE: TLLMBL FPAC: 9003130760#

TASK: ODID: 34-00466-03 DIN: DPN:

DRN:

DOCKET NO: 03014577 FICHE: 52955 244 52955 351 RIDS: ML309003140046 Matls licensing package for Amend 23 to License 34-00466-02 for Cleveland Clinic Foundation, Radiation Safety Ofc.

Control:383790.

FROM: PELKE , P . J . AFFIL: NE R3 I

TO: AFFIL:

ISSUED: 890112 AVAIL: PDR Spp. DOCUMENT TYPE: TLLMBL FPAC: 9003140046#

TASK: ODID: 34-00466-02 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 52958 141 52958 145 RIDS: ML3 0

. . _ _ _ _ _ . _ _ - m __ . _ . . _ _ _ . - - - - - . _ . __ _ _ . . . _ - _ _ _ .

7 a

U.S.-NUCLEAR REGULATORY. COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9004040205 Matls licensing package for Amend 40 to License 34-00466-01 for Cleveland Clinic Foundation. Control:386134, i ll FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 881219 AVAIL: PDR 7pp. DOCUMENT TYPE: TLLMBL FPAC: _9004040205# .

TASK: ODID: 34-00466-01 DIN: DPN:

DRN:

DOCKET NO: 03002649 FICHE: 53240 100 53240 106 RIDS: ML309004260150 Mat i.a licensing package for Amend 42 to License- 34-00466-01 for Cleveland Clinic Foundation. Control:386672.

1 FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 890222 AVAIL: PDR 3pp. DOCUMENT TYPE: TLLMBL FPAC: 9004260150#

TASK: ODID: 34-00466-01 DIN: DPN: * 'DRN: *-

-DOCKET NO: 03002649 FICHE: 53563 353 53563 355 RIDS: ML309006050128 Matls licensing packa'ge for Amend 10 to License 34-00466-03 for Cleveland Clinic. Foundation. Control:383571.-

FROM: PELKE,P.J. AFFIL: NE R3

-TO: AFFIL:

ISSUED: 881212 AVAIL: PDR -20pp. DOCUMENT TYPE: TLLMBL FPAC:. 9006050128*'

TASK: ODID: 00466-03 DIN: DPN: *- DRN:

DOCKET ~NO: 03014577 FICHE: 53995.317 53995 336 RIDS: ML30 c -e., , - .,-,. -y ..~o.- m gg.c v. 4 -,r..+< ,,- . . . , - e ,,-,-=n., , . , , , . . , . , , ,-,,y-

, - . . - - , . y- ., v,--.r.

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I F

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9006050132 Matls licensing package for Amend 22 to License 34-00466-02 for C.leveland Clinic Foundation. Control:383570.

FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 881212 AVAIL: PDR 21pp. DOCUMENT TYPE: TLLMBL FPAC: 9006050132*.

TASK ODID: 34-00466-02 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 53979 100 53979 119 RIDS: ML309006060001 Mat 1s licensing package for Amend 25 to License 34-00466-02 for Cleveland Clinic Foundation. Control:387976.

FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 891005 AVAIL: PDR 4pp. DOCUMENT TYPE: TLLMBL FPAC:. 9006060001*

TASK: ODID: 34-00466-02 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 54002 203 54002 206 RIDS: ML309006060377 Matls licensing package for Amend 39 to License 34-00466-01 for Cleveland Cll"ic Foundation. Control:383569.

FROM: PELKE,P.J. AFFIL:-NE R3 TO: AFFIL:

ISSUED: 881212 AVAIL: PDR' 22pp. DOCUMENT TYPE: TLLMBL FPAC: 9006060377*-

TASK: ODID: 34-00466-01 DIN: DPN:

DRN:

DOCKET NO: 03002649 FICHE: 54002 027 54002 048 RIDS: ML30 t v y 4 w N -- w *-

3_, _ mus Ma v : wrix sap:rw1muwm 1 U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9006070371 Matls licensing package for Amend 44 to License 34-00466-01 -

for Cleveland Clinic Foundation. Control:387975.

FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 891003 AVAIL: PDR 4pp. DOCUMENT TYPE: TLLMBL FPAC:- 9006070371* ,

TASK: ODID: 34-00466-01 DIN: DPN:

DRN: *

-DOCKET NO: 03002649 FICHE:-54048 129 54048 132 RIDS: ML309006250004 EN-90-061:on 900621, notice of proposed imposition of civil penalty in amount of $6,875 will be issued to licensee.

Action based on violation involving failure to rept therapy-misadministration within required 24-hr timo period.

FROM: JOHANSEN,J. AFFIL: NE SEN

-TO: AFFIL:

ISSUED: 900618 AVAIL: PDR 1p. DOCUMENT TYPE: TIEN FPAC: 9006250004#

TASK: ODID: EN-90-061 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 54253 322 54253 322 RIDS: IE33 9010110093 Matls licensing package for Amend 26 to License 34-00466-02 for Cleveland Clinic Foundation. Control:389401.

FROM: HUETER , L.J . AFFIL: NE R3 TO: AFFIL:

ISSUED: 900626 AVAIL: PDR 52pp. DOCUMENT TYPE: TLLMBL-FPAC: 9010110093#~

TASK: ODID: 34-00466 DIN: DPN:

DRN: *

-DOCKET NO: 03000394 FICHE: 55378 330 55379 020 RIDS: ML30

~

$ m ~ e v e r ---

. . _ . . . -. . ~ . . - ~, . -. _ . .

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9010180142 Matls licensing package for corrected Amend 26 to License 34-00466-02 for Cleveland Clinic Foundation.

FROM: HUETER , L. J . AFFIL: NE R3 TO: AFFIL:

ISSUED: 900718 AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 9010180142#-

TASK: ODID: 34-00466-02 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 55474 205 55474 206 RIDS: ML30 Y

9010240376 Matls licensing package for Amend 13 to License 34-00466-03 for Cleveland Clinic Foundation. Control:389995.

FROM: HUETER,L.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 900809 AVAIL: PDR 8pp. DOCUMENT TYPE: TLLMBL FPAC: 9010240376#

TASK: ODID: 34-60466-03 DIN: DPN:

DRN:

DOCKET NO: .03014577 FICHE: 55486 351 55486 359 RIDS: ML309010300156 Matls licensing package for Amend 45 to License 34-00466-01 for Cleveland Clinic Foundation. Control:389597.

FROM: FRAZIER,C.F. AFFIL: .NE R3

-TO: AFFIL:

ISSUED: 900725 AVAIL: PDR 7pp. DOCUMENT TYPE: TLLMBL FPAC: 9010300156#

TASK: .ODID: 34-00466-01 DIN: DPN:

DRN:

DOCKET NO: 03002649 FICHE: 55538 084 55538 090 RIDS: ML30

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9011190156 Matls licensing package for Amend 27 to License 34-00466-02 for Cleveland Clinic Foundation. Control:389799.

FROM: HUETER,L.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 900926 AVAIL: PDR 7pp. DOCUMENT TYPE: TLLMBL FPAC:- 9011190156# _

TASK: ODID: 34-00466-02 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 55783 061 55783 067 RIDS: ML309101080261 Matls licensing package for Amend 46 to License 34-00466-01 for Cleveland Clinic Foundation. Control:389951.

FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 901114 AVAIL: PDR 26pp. DOCUMENT TYPE: TLLMBL FPAC: 9101080261#

TASK: ODID: 34-00466-01 DIN: DPN:

DRN:

DOCKET NO: 03002649 FICHE: 56348 117 56348 142 RIDS: ML309101180246 Matls licensing package for Amend 28 to License 34-00466-02 for Cleveland Clinic Foundation, terminating license.

Control:390533.

FROM: NULL,K.G. AFFIL: NE R3 20 0 : AFFIL:

ISSUED: 901217 AVAIL: PDR 10pp. DOCUMENT TYPE: TLLMBL FPAC: 9101180246#

TASK: ODID: 34-00466-02 DIN: DPN:

DRN:

DOCKET NO: 03000394 FICHE: 56449 322 56449 331 RIDS: ML30

,m .' uw w U.S. NUCLEAR REGULATORY COMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9102070440 Matls licensing- ackage for Amend 47 to License 34-00466 for-Cleveland Clinic Foundation. Control:390604.

FROM: PELKE,P.J. -AFFIL: NE R3 TO: AFFIL'

_ ISSUED: 901220 AVAIL: PDR 6pp. DOCUMENT TYPE: TLLMBL FPAC:- 9102070440#

TASK: ODID: 34-00466-01 DIN: DPN: -* - DRN:-*

DOCKET NO: 03002649 FICHE: 56620 267 56620 272 RIDS: ML309102250190 Voided matls licensing action for License 34-00466-03 for Cleveland Clinic Foundation. Control:390698. -

FROM: JONES,J.. AFFIL: NE R3 TO:

AFFIL: NRCZ ,

ISSUED: 910214 AVAIL: PDR 8pp. DOCUMENT TYPE: CMMEMO FPAC: -9102250190.# ,

TASK: ODID: 390698 DIN: DPN:-

DRN:

DOCKET NO: 03014577 FICHE: 56802 043 56802 RIDS: ML30

___ ________________________________________050 _______

9103150049 Matls licensing package for corrected Amend-47 to License 34-00466-01 for. Cleveland Clinic Foundation.

FROM: PELKE,P.J. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910211 AVAIL: PDR 3pp. DOCUMENT TYPE: TLLMBL FPAC: 9103150049#__

-TASK: ODID: 34-00466 DIN: DPN:

DRN:

DOCKET NO: 03002649 FICHE: 57050-326 57050 328 RIDS: ML3 0

% .,.y. . _ _- _

w 4-m-- <-#r% r e

d U.S;.-NUCLEAR REGULATORY COMMISSION

. NUDOCS PARTIAL RECORD FORMAT REPORT 9105200298 Matls-licensing package for amend 14 to license 34-00466-03 for Cleveland Clinic Foundation. Control:391011.

FROM: JONES,J.D. AFFIL: NE R3 l

TO: AFFIL: -

-ISSUED: 910219 AVAIL: PDR 8pp. DOCUMENT TYPE: TLLMBL FPAC: 9105200298#'

TASK: ODID: 34-00466-03 DIN: - DPN:- DRN:

DOCKET NO: 03014577 FICHE: 57792 256 57792 264 RIDS: ML309105300030 - PNO-III-91-021:on 910516, evidence found of radioactive contamination. Caused by leaking P-32 valve.All areas contaminated were decontaminated or restricted to allow decay.Further evaluations of-contamination pending.

FROM: SCHULTZ,W. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910520 AVAIL: -PDR 2pp. DOCUMENT' TYPE: TIPNOT FPAC:' 9105300030A TASK: ODID: PNO-III-91-021-DIN: DPN: DRN:

DOCKET NO: 03002649 RIDS::IE34 FICHE: 57865-320 57865 321 9106100170 Matls licensing package for amend 48 to'11 cense 34-00466-01 for Cleveland Clinic Foundation. Control:391035.

i.

FROM: * . AFFIL: NE R3 TO: AFFIL:~

ISSUED: 910424 AVAIL: PDR' 5pp. DOCUMENT TYPE: TLLMBL FPAC: _9106100170#

TASK: ODID: 34500466-01. DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 58029-343 58029 347 -RIDS: ML30

$ ...w.W , - .m, . , - _ , f- - , m, . . g. -e esw-'a v 'e'- *- v=

et en 4 u,wy'E-ae e=- ' &

m. ~ ga . s w :~w up. ma n wsu U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT p

9106100338 Volded matls licensing action for license 34-00466-02'for Cleveland Clinic Foundation. Control:390215.:

'FROMt

AFFIL: NE R3

-TO:

AFFIL: NIRDFAL ISSUED: 910122 AVAIL: PDR 8pp. DOCUMENT TYPE: CMMEMO FPAC: 91061003380 TASK: ODID: DIN: DPN: DRN:-

DOCKET NO: 03000394. FICHE: 58024 196 58024 203 RIDS: ML30-9107160354 Insp rept 30-02649/91-01 on 910518-0618. Violations noted..

Major areas inspected: events re Apr 1991 therapy misadministration & 910516 spill of P-32-resulting in onsite

& offsite contamination.

FROM: CAMERON , J . L. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910710 AVAIL: PDR 22pp. DOCUMENT TYPE: TIINSP FPAC: 9107160345A r

TASK: ODID: 30-02649/91-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 59261 145 59261 172 RIDS:

9108020020 Enforcement Conference Rept 30-02649/91-02 on 910715. Major areas discussed: findings from 910518-0618 insp re accuracy of facts, causal factors, corrective actions taken-or planned by licensee & NRC enforcement policy.

FROM: CAMERON,J.L. AFFIL: NE R3-

'TO: AFFIL:

ISSUED: 910723 AVAIL: PDR 39pp. DOCUMENT TYPE: TIINSP FPAC: 9109180235A TASK:- ODID: 30-02649/91-02 DIN: DPN:. -DRN:-

L _ DOCKET NO: 03002649 FICHE: 59261 192 59261 229 -RIDS:

L l

~. - - . . - . ._ . .. . . .. ._

U.S. NUCLEAR REGULATORY. COMMISSION NUDOCS PARTI AL RECORD FORMAT REPORT 9109180208 FOIA requests for documents re 910516 spill of radioactive matl at Cleveland Clinic in Cleveland,OH.

FROM: DAVIS,D. AFFIL: ECIPLAIN TO: GRIMSLEY,D. AFFIL: NEAACS ISSUED: 910812 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9109180208#

TASK: ODID: DIN: DPN: DRN:

DOCKET NO: FICHE: 59261 130 59261 131- RIDS:

9109180235 Partial response to FOIA request for documents re 910516 spill of radioactive matl at Cleveland clinic. Info partially withheld re FOIA exemption 5,6 & 7.

FROM: AFFIL:

TO: DAVIS,D. AFFIL: ECIPLAIN ISSUED: 910904 AVAIL: PDR 5pp. DOCUMENT TYPE: CLOUT FPAC: 9109180235*

TASK: ODID: DIN: DPN: DRN:

DOCKET NO: FICHE: 59261 132-59261 140 RIDS:

9109190115 Matls licensing pa:kage for amend 49'to license 34-00466-01 for Cleveland Clinic Foundation. Control:391626.

FROM: MCCANN,G.M. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910822 AVAIL: PDR 8pp. DOCUMENT TYPE: TLLMBL FPAC: 9109190115#

TASK: ODID: 34-00466-01 DIN: DPN: DMI:

DOCKET NO: 03002649 FICHE: 59208 354 59208 361 RIDS: ML30 w

4 U.S.J NUCLEAR REGULATORY COMMISSION-NUDOCS. PARTIAL RECORD FORMAT REPORT

-9111080212 Matls licensing package for corrected amend 49 to license 34-00466-01 for Cleveland Clinic Foundation.

FROM: NULL,K.G. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910906- AVAIL: PDR 2pp. DOCUMENT TYPE: TLLMBL FPAC: 9111080212#

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 59706 250 59706 251 RIDS: ML309111120341 Matls licensing package for amend 2 to license SNM-1971 for Cleveland Clinic Foundation. Control:391882.

FROM: FRAZIER,C.F. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910912 AVAIL: PDR 70pp. DOCUMENT TYPE: TLLSNM FPAC: 9111120341#

TASK: ODID: SNM-1971 A 02 DIN:- DPN: DRN:

DOCKET NO: 07003044 FICHE: 59701 201 59701 271 RIDS: ML309111120346 Matls licensing package for' amend 50 to license 34-00466-01 for Cleveland Clinic Foundation. Control:391883.

FROM: FRAZIER,C.L. AFFIL:.NE R3-TO: AFFIL:

ISSUED: 910912 ; AVAIL: PDR. 43pp.. DOCUMENT TYPE: TLLMBL FPAC: 9111120346#

TASK: ODID: 34-00466-01 DIN: DPN: DRN:'

DOCKET NO - 03002649 FICHE: 59701 141 59701'183 RIDS: ML30

-t, y. - -

r.-,y 3 -.

.m..f - .,-,s . - - -

-_-w -

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U.S. NUCLEAR-REGULATORY' COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9111120360 Matls licensing package for amend 8-to. license 34-00466-04 for Cleveland Clinic Foundation. Control:391884.

FROM: FRAZIER,C. AFFIL: NE R3 TO: AFFIL:

ISSUED: 910912 AVAIL: PDR 37pp. DOCUMENT TYPE: LTLLMBL FPAC:- 9111120360#

TASK: ODID: 34-00466-04 DIN: DPN: DRN:'-

DOCKET NO: 03017931 FICHE: 59654 136 59654 172 RIDS: ML309201270235 PNO-III-92-001 on 920117, licensee reported that patient received radiation dose 57% greater than~ prescribed in therapeutic treatment. Licensee investigating event to determine cause of error. Written rept will be submitted.

'FROM: S LAWINSKI, W. AFFIL: NE R3 i

TO: AFFIL:

ISSUED: 920121 AVAIL: PDR 1p. DOCUMENT TYPE: TIPNOT'FPAC: 9201270235#

TASK: ODID: PNO-III-92-001 DIN: DPN: DRN:

DOCKET NO: 03017931 FICHE: 60372 171 60372 171 RIDS: IE34 9202040201 Matls licensing package for amend 3 to license SNM-1971 for Cleveland Clinic Foundation. Control:392465.

FROM: . NULL,K.G. AFFIL: NE R3

.TO: AFFIL:

ISSUED: 920109

~

AVAIL: PDR 4pp. DOCUMENT TYPE: TLLSNM FPAC: 9202040201#1

. TASK: ODID: SNM-1971 A-03 . DIN: DPN: DRN:

DOCKET NO: 07003044 FICHE: 60475-325 60475 328 RIDS:'ML30 e

. _. _ _ -_ -._ . . . . - . _ . . _ - _ ~ . . _ . _ . _ . _ _ _ .

6 U.S. NUCLEAR REGULATORYLCOMMISSION NUDOCS PARTIAL RECORD-FORMAT REPORT T9204070026 Insp repts 30-02649/92-01 & 30-17931/92-01 on 920128-29.No violations noted. Major areas inspected:irradiators, records, '

brachytherapy storage room & interviews w/ personnel. -

FROM: REICHHOLD,W.P. AFFIL: NE R3-TO: AFFIL:

ISSUED: 920325 AVAIL: PDR 6pp. DOCUMENT TYPE: TIINSP FPAC: 9204070016A-TASK: ODID: 30-02649/92-01 DIN: DPN: DRN:

. DOCKET NO: 03002649 FICHE: 61228 159 61228 164 RIDS:

9206180331 Forwards Region III insp rept re teletherapy misadministration at Cleveland Clinic Foundation, Cleveland, OH.

FROM: WEIL,C.H. AFFIL: NRCZ TO: PAWLIK,E.T. AFFIL: NE R3 ISSUED: 870303 AVAIL: PDR 1p. DOCUMENT TYPE: CMMEMO FPAC: 9206180321A

-TASK: ODID: 34-00466-02 DIN: DPN:- DRN; DOCKET NO: 03000394 FICHE: 62105 024 62105 025. RIDS:

"9206180353 FOIA request for documents re Cleveland Clinic Foundation &

NRC Enforcement Action-EA-87-042.

FROM: DAVIS,D. AFFIL: ECIPLAIN-TO: GRIMSLEY,D. AFFIL: NEAACS ISSUED: 910911 AVAIL: PDR 1p. DOCUMENT TYPE: CLINC FPAC: 9206180353#

TASK: ODID:.EA-87-042 DIN: DPN: 'DRN:

DOCKET NO: FICHE: 62105 079 62105 079 RIDS:

. . . ..-. _ _~

y. - - -- -<

mmga ~w w a. dam.wa-:auw w

~

U.S. NUCLEAR REGULATORY JCOMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 19206180377 Partially deleted ltr re Cleveland Clinic Foundation' furnishing incorrect info concerning teletherapy misadministration at clinic during Nov-1986.

FROM: WEIL,C.H. AFFIL: NE R3 ,

TO:.* AFFIL: EMDCLEV-ISSUED:- 890130 ' AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: - 9206180321AJ -

TASK: ODID: 34-00466-02 DIN: DPN: DRN:.

DOCKET NO: 03000394 FICHE: 62105 077-62105 077 RIDS: -

w

-9207080132 Partial response to FOIA request for documents re-Cleveland Clinic Foundation &:NRC Enforcement Action EA-87-042.

FROM: GRIMSLEY,D.H. AFFIL: NEAACS-TO: DAVIS,D. AFFIL: ECIPLAIN

. ISSUED: 911029 AVAIL: PDR 3pp. DOCUMENT TYPE: CLOUT FPAC:.9207080132*

TASK:- ODID: .EA-87-042 DIN: DPN:' DRN:

DOCKET NO: FICHE: 62262 095 62262-141 . RIDS:

- 9207080285 Requests for assist to.insp of Cleveland' clinic, Cleveland,OH based on recent events involving potentially unreported therapeutic misadministration.

FROM: . DAVIS,A.B. AFFIL: NE R3 TO: - PAWLIK,E.T. AFFIL:-NE R3

-ISSUED: 861120- AVAIL: PDR 3pp'. DOCUMENT TYPE: -CMMEMO FPAC:L9207080281A TASK: ODID:- LDIN: DPN: DRN:

DOCKET NO: ' FICHE: 62273 141 62273 143' RIDS:

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U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT:

9207080331 Forwards OI rept of assist to insp concerning Cleveland Clinic foundation re alleged misadministration (CASE A3-86-011).

FROM: PAWLIK,E.T. AFFIL: NE R3 TO: DAVIS,A.B. AFFIL: NE R3' ISSUED: 871009 AVAIL: PDR Spp. DOCUMENT TYPE: CMMEMO FPAC: 9207080281A TASK: ODID: DIN: DPN: DRN:

DOCKET NO: FICHE: 62273 219 62273 226 RIDS:

9207080346 Discusses assist to insp by RIII-OI re Cleveland Clinic Foundation concerning alleged misadministration.

FROM: HIND,J.A. AFFIL: NE:R3 TO: WEIL,C.H. AFFIL: NE R3 ISSUED: 871110 AVAIL: PDR 16pp. DOCUMENT TYPE;-CMMEMO FPAC: 9207080281A TASK: ODID: DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 62273 227 62273 243 RIDS:

9207150087 FOIA request for all diagnostic misadministration repts filed by Cleveland-Clinic Foundation in Cleveland,OH for insp &/or_ photocopying.

FROM: DAVIS,D. AFFIL: ECIPLAIN:

TO: GRIMSLEY,D. AFFIL: NEAACS ISSUED: 911018 AVAIL: PDR 1p. ' DOCUMENT TYPE: CLINC FPAC: 9207150087#

TASK: ODID: DIN: RDPN: DRN:

, DOCKET NO: FICHE: 62546 001-62546 001 RIDS:

4

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9207150108 Final response to FOIA reguest for all diagnostic misadministration repts filed by Cleveland Clinic Foundation in Cleveland,OH. App A documents being made available in PDR.

FROM: GRIMSLEY,D.H. AFFIL: NEAACS TO: DAVIS,D. AFFIL: ECIPLAIN ISSUED: 911104 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9207150108*

TASK: ODID: DIN: DPN: DRN:

DOCKET NO: FICHE: 62546 002 62546 063 RIDS:

9207270317 Final response to FOIA request for documents re special insp of Cleveland Clinic Foundation, Cleveland,OH on 820413-14.

Forwards documents listed in App A,which are being made available in PDR.

FROM: GRIMSLEY,D.H. AFFIL: NEAACS TO: DAVIS,D. AFFIL: ECIPLAIN ISSUED: 911119 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9207270317#

TASK: ODID: DIN: DPN: DRN:

DOCKET NO: FICHE: 62519 292 62519 308 RIDS:

9208140019 _ Responds to 911008 appeal of NRC 910912 response denying portions of 148 page record concerning 910516 spill of radioactive matl at Cleveland Clinic. Informs that appeal partially granted & partially denied.

FROM: THOMPSON,H.L. AFFIL: NOMA TO: DAVIS,D. AFFIL: ECIPLAIN ISSUED: 911206 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9208140019*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 62772 243 62772 271 RIDS:

+ - - - *

^

~~ R G A R L L Ll& d M i & ' " f t

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U.S. NUCLEAR REGULATORY COMMISSION !

NUDOCS PARTI AL RECORD FORMAT REPORT

i 9208140022 Appeals NRC 910912 responso to FOIA requent for portions of- t 148 page record concerning 910516 spill of radioactive snatl '

at Cleveland Clinic. !

t FROM: DAVIS,D. AFFIL: ECIPLAIN TO:

AFFIL: NE ED ISSUED: 911008 AVAIL: PDR 2pp. DOCUMENT TYPE: CLINC FPAC: 9208140022# )

TASK: ODID: 34-00466-01 DIN: DPN DRN DOCKET NO: 03002649 PICllE t 62772 241 62772 242 RIDSt t

-9208140034 Puchago consisting of partially dolotod pagos of 148 pago record to 910516 spill of radioactive matl at Cleveland ;

Clinic.

FROM:

AFFIL: NRCZ TO: AFFIL:

.r ISSUED: 920814 AVAIL: PDR 2pp. DOCUMENT TYPE: VADPKG FPAC: 9208140019A TASK ODID: 34-00466-01 DIN: DPHI DRN:

DOCKET No: 03002649 FICilEl 62772 245 62772 271 RIDS:

l.

U.S. 11UCLEAR RECULATORY COMMISSIO!1 11UDOCS PARTI AL RECORD FORMAT REPORT 8205200094 Confirms 820527 meeting V/liosp in Clevoland,Oli to discuss 820413-14 insp & corrective actions.

FROM: KEPPLER,J.G. AFFIL: 11E R3 TO: KRIEGER,J. AFFIL: EMDCLEV ISSUED: 820517 AVAIL: PDR 1p. DOCUMEliT TYPE: CLOUT FPAC: 8205200094#

TASK: ODID: 34-00466-02 Dill: DPN DR11:

DOCKET NO: l'ICilE : 13167 227 13167 227 RIDS: IE07 E20'J150259 Ack receipt of 820812 ltr informing 11RC of steps taken to correct violations noted in IE insp of License 34-00466-02.

FROM: !JORELIUS , C. E. AFFIL: NE R3T TO: KRIEGER,J. AFFIL: EMDCLEV ISSUED: 820907 AVAIL: PDR 1p. DOCUME!JT TYPE: CLOUT FPAC 8209150259*

TASK: uDID: 34-00466-02 DIN: DPN: DRil:

DOCKET NO: 03000394 FI CllE : 14884 343 14884 346 RIDS: IE07 8312050269 Diucusses IE insp of Licenses 34-00466-01,34-00466-02, 34-00466-03 & 34-00466-04 on 831117 & forwards notice of violation.

FROM: SRENI AKSKI, D.J . AFFIL: llE R3 TO: PAV LI C E K , W . AFFIL: FMDCLEV ISSUED: 831129 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8312050269*

TASK: ODID: 34-00466-01 DI!1: DPN: DRN:

DOCKET NO: FICilE : 21381 195 21381 196 RIDS: IE07

n _w = ~. gw .

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U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8312200278 Ack receipt of 831205 ltr informing NRC of steps taken to i correct violations noted in IE insp of License 34-00466-01.

FROM: SRENI AWSKI , D.J . AFFIL: NE R3 ,

TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 831215 AVAIL: PDR 1p. DOCUMENT TYPE: ? LOUT FPAC: 8312200278*

TASK: ODID: 34-00466-01 DIN: DPN: DRN DOCKET NO: 03002649 FICllE: 21575 349 21575 350 RIDS: IE07

~8403080209 Discusses IE Insp Rept 30-00394/82-01 on 820413 &-14 &

forwards notice of violation. 4 FROM! NORE LIUS , C . E . AFFIL: NE R3 TO: KRIEGER,J. AFFIL: EMDCLEV ISSUED: 820721 AVAIL: PDR 2pp. DOCUMENT TYPEt CLOUT FPAC: 8403080016A

'1 ASK : ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: 03000394 FICllE: 22577 318 22577 319 RIDS:-

8403080217 submits questions,por 820420 telcon-re misadministration.

Info will be kept confidential.

FROM: SAENGER,E.L. AFFIL: NRCZ TO: RODRIGUES,A_ AFFIL: EMDCLEV '

ISSUED: 820423 AVAIL: PDR 1p. . DOCUMENT TYPE: CLOUT FPAC: 8403080016A TASK ODID: DIN: DPN: DRN

DOCKET NO: FICHE: 22577'347 22577 349 RIDS:

l'

, - , . , , .. ,,,.,,,,.y.~m. - - , . , . _ ,._.4 _, ..-#, ,...o,_,.. +~~.__.,_._.-_.____.m_.___,.,_,__,_m..- - - . . _ , . , . _ , . .

.-___m.-_ __ _ _ . _ . _ _ _ . . _ _ _ . _ _ . _ _ _ _

l U.S. NUCLEAR REGULATORY COMMISSION .

HUDOCS PARTIAL RECORD FORMAT REPORT i

8409130469 Forwards Amend 28 to License 34-00466-01. Info given in -

support of request for use of Gd-153 in humans insufficient i for review.Addl info required listed.

FROM: HOLT,B.J. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 840816 AVAIL: PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 8409130467A ,

TASK ODID: 34-00466-01 DIN: DPN: DRH: I DOCKET NO: 03002649 FICHE: 26465 066 26465 068 RIDS:

.......-----....--...-----...........----- t 8410310057 Forwards Amend 16 to License 34-00466-02, Amend 6 to 34-00466-03, Amend 2 to 34-00466-04 & Amend 2 to SNM-1659.

Document'should be reviewed & all conditions understood. ,

FROM: HOUT,B.J. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 840928 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC:-8410310046A TASK ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: FICHE: 27228 127 27228 128 RIDS:

' 8412050770- Forwards Amend 29 to License 34-00466-01. License conditions noted. ,

FROM: HOUT,B.J. AFFIL: NE-R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 841023 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8412050764A -

~

TASK: ODID: 34-00466-01 DIN:. DPN: DRN:

DOCKET NO: 03002649 FICHE: 27779-214 27779 215 RIDS:

I I

E

,,,r,,,, -,-,,w,.--r.,.cw wr-,,-- ,,---,,._n,--.,,,-_,w,, ~m,+-- m,- ,w.n_.,.--,, , -.,_,,,,mnn+n, , ..un ....v+-.nn -,,--+en-, -r-mn~em.,

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8503080207 Forwards Amend 17 to License 34-00466-02. License conditions noted.

FROM: ADAM,W.J. AFFILf NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 850212 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8503080203A TASK! ODID: 34-00466-02 DIN: DPN DRN:

DOCKET NO: 03000394 FICHE: 29284 339 29284 340 RIDS:

8512240052 Discusses safety insp of Licenses 34-00466-01 & 34-00466-02 on 851205 & 06 & forwards notice of violation. Actions described in 831205 ltr re apparent items of noncompliance found during 831117 insp examined.

FROM: WIEDEMAN,D.G. AFFIL: NE R3 TO: EVERSMAN,J.J. AFFIL: EMDCLEV ISSUED: 851220 AVAIL: PDR 3p. DOCUMENT TYPE: CLOUT FPAC: 8512240052*

TASK: ODID: 34-00466-01 DIN: DPN! DRN:

DOCKET NO: 03000394 FICHE: 34030 226 34030 227 RIDS: IE07

'8601310039 Ack-receipt of 860107 ltr informing NRC of steps taken to correct nonco.npliance noted in insp of Licenses 34-00466-01

&-34-00466-02 on 851205-06. Daily survey-of hot lab'& program not included in 790719 application. Noncompliance voided.-

FROM: WIEDEMAN,D.G. -AFFIL: NE R3 TO: EVERSMAN,J.J. AFFIL: EMDCLEV ISSUED: 860128 AVAIL: PDR 1p.- DOCUMENT--TYPE: CLOUT FPAC:-8601310035A TASK ODID: 34-00466-01 DIN: DFN: DRN:

DOCKET NO: 03000394 FICHE: 34426 320 34426 320 RIDS:-

a n., ~, -. g t ..:. m .;. x . x 1 w w . u yw U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT

-8610030350 Forwards Amend 4 to License 34-00466-04. Condition 16 requires that licensco perform radiation survey prior to initiation of irradiation program & submittal of survey results. Record of 860602 talcon enc 1.

FROM: WHISTON,P.J. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 860722 AVAIL: PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 8610030337A TASK ODID: 34 -30466-04 DIN: DPN DRN:

DOCKET NO: 03 017 9 31 ' le;1".4 18079 313 38079 315 RIDS:

..................... . . . . . .a,.......................

8610070425 Confirmatory action ltr requiring that planned experiment to implant Ir-192-brachytherapy sources in-pigs not be performed until-problems encountered during.oimilar work at -

Univ of Wisconsin analyzed & NRC final rept reviewed.

FROM: KEPPLER,J.G. AFFIL: NE R3 TO: ARON,S. AFFIL: - EMDCLEV ISSUED: 860926 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8610070425#

TASK: ODID: CAL DIN: DPN: DRN:

DOCKET NO: 03002649 'FICllE: 38119 358 38119 359 RIDS: IE07 8610100276 Final response to FOIA request for NRC rept dealing wf incident at Univ of Wisconsin re use of Ir-192 radiation I sources for implantation in-pigs.HRC has no records subj to request.

FROM: GRIMSLEY,D.H. AFFIL: NEARR TO: ARON,S.J. AFFIL: EMDCLEV ,

ISSUED: 861003 AVAIL: PDR= -1p. DOCUMENT TYPE: CLOUT FPAC: 8610100276#-

L TASK: ODID: DIN: DPN DRN:

DOCKET NO: FICilE: 38206 287 38206 287 RIDS:

l L

n-~w%, ,,,-vwrm,. -m, +.w_Mu, 4 4,u- ,we_. ie. #_ .y .a4. ....c%_,s %._ www-y -.m..m...,mm,

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTI AL RECORD FORMAT REPORT 8611250379 Confirmatory action ltr re Co-60 teletherapy misadministration reported on 861117. Actions to be taken to prevent recurrence of error listed.

FROM: KEPPLER,J.G. AFFIL: NE R3 TO: THOMAS,F. AFFIL: EMDCLEV ISSUED: 861120 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8611250379A TASK: ODID: CAL DIN: DPHI DRN DOCKET NO: 03017931 FICHE: 62105 109 62105 110 RIDS: IE07 8612020480 Forwards Amend 33, renewing License 34-00466-01. Lunar Radiation Corp Model SP2 not specifically listed-on licence, since afg issued medical distribution license to distribute device to licensees authorized to possess Group VI matls.

FROM: ADAM,W.J. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 860910 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC 8612020477A TASK: ODID: 34-00466-01 DIN: DPN DRN DOCKET NO: 03002649 FICHE: 38785 091 38785 092 RIDS:

8612020536 Informs that license may be terminated if response to 860701 i request for addl info re 850118 application for-renewal of License 00466-01 not received within 30 days.

FROM:-MALLETT,B.S. AFFIL: NE RJ TO: ARON,S.J. AFFIL: EMDCLEV- :

ISSUED: 860805 AVAIL: .PDR: 1p. DOCUMENT TYPE: CLOUT -FPAC: 8612020477D TASK: ODID: 78168 DIN: DPN: DRN:

n DOCKET NO: 03002649 FICHE: 38785 099 38785 099 R'I DS :

I

-,_ %,,# . m ._ _ m U.S. NUCLEAR REGULATORY COMMISSION liUDOCS PARTIAL RECORD FORMAT REPORT 8612020546 Requests listed addl info in order to continue review of 850118 application for renewal of License 34-00466-01. Record of 851024 telcon enc 1.

FROM: ADAM,W.J. AFFIL: 11E R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 860701 AVAIL: PDR 4pp. DOCUMEliT TYPE: CLOUT FPAC: 8612020477E -

TASK: ODID: 78168 DIN: DPN: DRN:

DOCKET 110: 03002649 FICHE: 38785 100 38785 103 RIDS: ,

8612020564 Ack receipt of application for renewal of License 34-00466-01.

FROM: MALLETT,B.S. AFFIL: NE R3 TO: ARO!1, S . J . AFFIL: EMDCLEV ISSUED: 850228 AVAIL: PDR 1p. DOCUME!1T TYPE: CLOUT- FPAC: 8612020477G-TASK: ODID: 78168 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 38785 116 38785 116 RIDS:

8612310301 Final response to FOIA request. App A document re Insp Rept 30-03465/86-01 enci & also available in PDR. App A document partially withheld (ref Exemption 6).

FROM: GRIMSLEY,D.H. AFFIL: NEARR TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 861229 AVAIL: PDR 3pp. ' DOCUMENT TYPE: CLOUT FPAC: 8612310301*

TASK: ODID: DIN:- DPN: DRN:_

DOCKET NO: FICHE: 39131 050 39131 101 RIDS:

mm er=i ie i

. . - - . - . - - . - - . _ . . - _ - . _ _ . - - - - - ~.- - -.- - . - - _

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U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8702050171 Responds to 861218 submittal of new proposed radiation therapy QC/QA program. Review concluded that listed areas should be revised or clarified. Response requested within 30 ,

days.

FROM: HIND,J.A. AFFIL: NE R3 rO: THOMAS,F.J. AFFIL: EMDCLEV ISSUED: 870126 AVAILt PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 8702050171*

, TASK ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 39512 319 39512 339 RIDS: IE07 8702250339 Forwards notice of 870304 significant licensoo mooting w/ Cleveland Clinic Foundation in Glen Ellyn,IL to discuss-violations identified during recent insp, corrective actions

& enforcement options available,per 870218 telcon.

FROM: HIND,J.A. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV ,

ISSUED: 870219 AVAIL: PDR 2pp. DOCUMENT TYPE:-CLO'UT FPAC: 8702250339A TASK: ODID: 34-00466-02 DIN: DPN: DRN:.

DOCKET NO: 03000394 FICHE: 62105 088 62105 089 RIDS: IE07

' 8702260600 Forwards License SNM-1971.

FROM: MCCANN,G.M. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 861021 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT--FPAC:- 8702260593A TASK:- ODID: SNM-1971 DIN: DPN: DRN:

DOCKET NO: 07003044 FICHE: 39757 287 39757 288 RIDS:

' ~

m .nn ,,,,-,,-,nrg, n. 'n,,-,.,~,--,,,e-

-- , , . 5,-um r.,,,,rm.-, , - r, s e ,:~,.-n,e.-

__ _ . _ . ~ . . . _ _ _ _ _ . _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ __

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U S. NUCLEAR REGULATORY COMMISSION '

NUDOCS PARTIAL RECORD FORMAT REPORT ,

i i

8702260647 Roquests addl info ro 760419 application for license to ;

participato in investigational program utilizing Coratomic !

Model C-101 nuclear-powored pacemakers, including list of- l surgeon members of study team.

.' FROM: VACCA,P.C. AFFIL: NOMCMRL TO: COOK,G. AFFIL: EMDCLEV ISSUED: 760517 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8702260593E

-TASK: ODID: SNM-1659 DIN: DPN: DRN !

i DOCKET NO: 07002213 FICHE: 39757 315 39757-316 RIDS:

8702260658 Roquests addl info re application for licenso to participato in clinical evaluation of Nuclear Omni-Stanicor Model 184-A '

nuclear-poworod pacemaker, including list of cardiologist &

surgeon members of study team.

FROM: VACCA,P.C. AFFIL: NOMCMRL i

TO: CASTLE,L.W. - AFFIL: EMDCLEV ISSUED: 760330 AVAIL: PDR 2pp. DOCUMENT TYPE: CLnUT FPAC: 8702260593H TASK: ODID: SNM-1659 DIN: DPN: DRN DOCKET NO: 07002213 FICHE: 39757 323 39757 324 RIDS:

8703200443 Forwards Enforceme... Conference Rept 30-00394/87-01 on 870304.Licensoo will be notified by separato correspondence of NRC decision to enforcement actions based on info presented & discussed at conference.

FROM: HIND,J.A. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV

. ISSUED: 870318 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8703200443A TASK ODID: 34-00466-02 DIN: DPN - DRN:

1 DOCKET NO: 03000394 FICHE: 62105 090 62105 099 RIDS: IE46-

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U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8704220130 Forwards Safety Insp Repts 30-02649/87-01,30-00394/87-01, 30-14577/87-01,30-17931/87-01 & 70-3044/87-01 on 870323-25 &

notico of violation. Concern re agt control sys expressed &

improvements requested.

FROM: AXELSON,W.L. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV ISSUED: 870415 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9207080132A _

- TASK: ODID: 34-00466-01 DIN: DPN: DRN DOCKET NO: FICHE: 62262 103 62262 137 RIDS: IE07 8704290199 Forwards Insp Rept 30-00394/86-01 cnr 861120-870210 & notice of violation & proposed imposition of civil penalty in amount of $2,500. Enforcement conference held on- 870304. Notes breakdown of mgt control of radiation therapy program.

FROM: DAVIS,A.B. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV ISSUED: 870415 AVAIL: PDR 3pp. DOCUMENT TYPE: CLOUT FPAC: 9203060423A-TASK: ODID: EA-87-042 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 60899 024 60899 028 RIDS: IE14 8706240090 Ack receipt of 870514 payment for civil penalty in amount of

$2,500. Corrective actions will be examined during future insps.

FROM: LI EBERMAN , J . AFFIL: NE SEN To: KISER,W.S. AFFIL: EMDCLEV-ISSUED: 870622 AVAIL: PilR 4pp. DOCUMENT TYPE: CLOUT- FPAC: 9207080132A TASK: ODID: EA-87-042 DIN: DPN: DRN:

DOCKET NO:. 03000394 FICHE: 62262 138 62262 141 RIDS: IE14 iisi,i.iiini i nii

t i

f U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8801110106 Forwards Amend 8 to License 34-00466-03.

2 h

FROM: WHISTON,P.J. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 870731 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8801110104A TASK: ODID: 34-00466-03 DIN: DPN DRN DOCKET NO: 03014577 FICHE: 43971 221 43971 222 RIDS: ,

8801110449 " BASEMENT FLOOR PLAN NUCLEAR MEDICINE HOSP G WING."

FROM:

AFFIL: EECBARHO i TO:

AFFIL: EMDCLEV ISSUED: 860329 AVAIL: PDR 1p.

DOCUMENT TYPE: DDDRAW FPAC: - 8801110371B TASK: ODID: A-1 DIN: DPN DRN:-

DOCKET 03000394 FICHE:

---. ___NO:............__......38260 001 38260:001 _ RIDS:

f 8801120187 Forwards Amend 35 to License 34-00466-01. Changes in radioisoope-committee not authorized, Condition 11.A i corrected to autorize RT Go as chairman of committee'&

survey required for od nuclear medicine & cardiology areas.

FROM: MALLETT,B.S. AFFIL: NE R3

-TO: ARON,S.J. AFFIL: EMDCLEV ISSUED:- 870717 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT- FPAC: 8801120185A- .

TASK: ODID: 34-00466-01 DIN: DPN: DRN: ,

DOCKET NO: 03002649 FICHE: 43998 170 43998 171 RIDS:

h ry 4 - , . - - - . -

,--x-.,.g ,..,,vy-,.-,,,,.,,,me,, .,m,.m.._,.-.mm.,, -. . . , , , , - . . , ,

,e zw , w_g m )

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i U.S. NUCLEAR: REGULATORY COMMISSION ,

NUDOCS PARTIAL RECORD FORMAT REPORT L 8807180094 Forwards Amend 6 to License 34-00466-04. f i

FROM: FRAZIER,C. AFFIL NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 880328 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 8807180092A TASK ODID 34-00466-04 DIN: DPN: DRN DOCKET NO: 03017931 FICHE: 46199 268 46199 269 RIDS:

l 8808190084 Forwards order-modifying license issued to all users of JL '

Shepherd self-shielded Irradiators-(Model 81-22).

FROM: WIEDEMAN,D.G. AFFIL: NE'R3-TO:

AFFIL: EMDCLEV ,

ISSUED: 880816 AVAIL: PDR -- 1p. DOCUMENT TYPE: CLOUT FPAC: 8808190084# ;

TASK: ODID: 34-00466-04 DIN: DPN: DRN: ;

DOCKET NO: 03017931 FICHE: 46599 214 46599 217 RIDS: IE07 F

8811230354 Forwards Insp Rept 30-00394/88-01 on 880811.Two cases of possible.misadministrations re use of Co-60 telethorapy machine evaluated,per 880418 ltr.NRC concerns pertaining to potential violations in case 2 under review.

FROM: NORELIUS,C.E. AFFIL: NE R3

- TO: KISER,W.S.- AFFIL: EMDCLEV.

ISSUED: 881115 AVAIL: PDR 2pp. DOCUMENT' TYPE: CLOUT FPAC: 8811230354*

TASK: - ODID:.EA-88-273 DIN: DPN - DRN DOCKET NO: 03000394 FICHE: 47652 162 47652 224 RIDS: IE54 I

t a p , - - nn-- , , . , - - e,..-.. ~.

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U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 8902140126 Forwards Amend 37 to License 34-00466-01.

FROM: MATSON,E.R. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 880310 AVAIL: PDR 4pp. DOCUMENT TYPE: CLOUT FPAC: 8902140122A TASK ODID: 384563 DIN: DPN DRN:

DOCKET NO: 03002649 FICHE: 48730 115 48730 118 RIDS:

8903030494 Discusses Insp 30-00394/88-01 on 880811 & forwards notice of violation. Advises that NRC carefully reviewed two cases discussed in licensec 880418 Itr.In-Case 1, dose appears to have been delivered from Co-60 sources as was prescribed.

PROM DAVIS,A.B. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV ISSUED: 890223 AVAIL: PDR 4pp. DOCUMENT TYPE: CLOUT FPAC: 9203060423A 1ASK: ODID: EA-88-273 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 60899 122 60899 126 RIDS: IE14

'8906290376 Clarifies NRC requirements for reporting misadministrations per 10CFR35.33(a).NRC views therapeutic misadministrations ,

as serious matter- & will issue notice of violation if-reporting notLin accordance1w/ regulations.

FROM: NORELIUS,C.E. AFFIL: NE R3 TO: ARON,S.J. AFFIL: EMDCLEV ISSUED: 890622- AVAIL: PDR 2pp. DOCUMENT' TYPE: CLOUT FPAC: '9203060423A

-- TAS K : ODID: EA-88-273 . DIN: DPN: DRN -

DOCKET NO: 03000394-FICHE: 60899 119 60899 121 RIDS:-IE07 i-E

_ _ . _ _ - m _-._m_ . _ _._.__ -.__ ___..____ _. -

1 i

l U.S. NUCLEAR REGULATORY COMMISSION-NUDOCS PARTIAL RECORD FORMAT REPORT ;

8912200118 Confirmatory Action Ltr CAL-RIII-89-24 re use of teletherapy unit at NASA,per 891213 telcon.

j FROM: DAVIS,A.B. AFFIL NE R3 I TO: LEES,J.E. AFFIL: EMDCLEV .

i ISSUED: 891214 AVAI L: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 8912200118# ;

TASK: ODID: CAL-RIII-89-24 Dill DPN: DRN:

DOCKET NO: 03014577 FICilEt 52075 159 52075 1591 RIDS: IE07 :

.i 9004300036 Confirms 900416 telcon to arrangements for enforcement conference on 900502 in Glen Ellyn,IL to discuss failure to rept therapeutic misadministration on timely basis, corrective actions & NRC enforcement uptions.Notico encl.

FROM: NORELIUS,C.E. AFFILi NE R3 TO: LEES,J.E. AFFIL: EMDCLEV

~ ISSUED: 900419 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9004300036#

TASK: ODID: EA-90-074 DIN: DPN

DRN:

DOCKET.NO: 03000394 FICliE 53636 080 53636 081 RIDS: IE07 i.

'l 9005000120 Forwards Safoty Insp Repts' 30-02649/90-01,30-00394/90-01, 30-14577/90-01 & 70-3044/90-01 on 900307-0405. Violations &

repeat concern for lack of-cooperation between therapy dept

& radiation safety ofc identified.

FROM: - NORELIUS,C.E. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV

- ISSUED: 900427 AVAIL: PDR 2pp. ~ DOCUMENT TYPE: CLOUT _ FPAC: 9005080120* i TASK: ODID: EA-90-v74 DIN: DPN: -

DRN: * '

DOCKET NO: FICIIE: 53769 299 53769 351 RIDS: IE07 i

1.

--,w -g[* -y- . - . . - , ,--e-,.r. ..e..M,- , < . , . - - - - , ..w,. ,,...,-7%,m,,.,.en3, y. c..y---<,n.mvw,,, n.m, ,r.-,_.m,we.3..,,,--.yr,---,y--,,

- - %;w2 m, a m e _ ._ _udud C - ~ ~~'^ ~~~~"~ ~~~~ ~ ~p p 4 I

L U.S. IlVCLEAR REGULATORY COMMISSIOli flVDOCS PARTI AL RECORD FORMAT REPORT r

1 9005290275 Forwardo Safety Insp Repts 30-02649/90-02,30-00394/90-02 & i 30-14577/90-02 on 900307-0420 & notico of violation, r FROM: NORELIUS,C.E. AFFIL: ilE R3 TO: LOOP,F. AFFIL: EMDCLEV !

ISSUED: 900522 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9005290275*

TASK: ODID: 34-00466-01 DIN: DPil

DRN: * ;

i

+

DOCKET NO: 03002649 FICllE 53947 257 53947 300 RIDS: IE07

, 9006130469 Forwardo Enforcement Conference Repts 30-02649/90-03 &

30-00394/90-03 on 900502.

FROM: llORE LI US , C. E . AFFIL: NE R3 i TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 900523 AVAIL: PDR 1p. DOCUMENT TYPEt CLOUT FPAC 9006130469*

TASK: ODID: EA-90-074 DIN: DPN:

DRN

DOCKET NO RIDS: IE46 ;

..... .... 03002649 FICllE: 54167 357 54167 360 9006270287 Forwards Insp Repta 30-00394/90-01 & 30-02649/90-01 on.

900307-09 & 14-16 & notico of violation &

imposition of civil penalty in amount of $ proposed 6,875.

FROM: DAVIS,A.D. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 900621 AVAIL: PDR _4pp. DOCUMENT TYPE: . CLOUT FPAC: 9203060423A TASK: ODIDr EA-90-074- DIN: DPHI DRN:

DOCKET NO: 03000394 FICllE: 60899 102 60899 118 RIDS: 'IE07 -

+

y y ey y- +,grywy--,-- y n -* v y v,--o- -yir,4 -y w w w w ,-,,,

wy-,--er<,,wre -y w w ,y.- w r w y -vyv w d w 7 --cma ne,w -

rywe s- ww w-s--+-m%,<*..--yme w - m r ew - er m +- w,- , y,ww v e- er e

f U.S. IlUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT i 9008270030 Ack recolpt of 900719 ltr forwarding paymont of civil !

penalty per NRC 900621 ltr.

FROM: LIEBERMAN,J. AFFIL: NE SEN TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 900009 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC 9008170030#

TASK ODID: EA-90-074 DIN: DPN

DRN

DOCKET NO: 03000394 FICllE t 54984 172 54984 172 RIDS: IE14 9012030078 Discussos 900502 enforcement conference w/ staff to discuss 11consee plans to improve apparent communications problem.

FROM DAVIS,A.D. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 901126 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC:-9012030078*

TASK ODID: 34-00466-01 DIN: DPN:

DRN

DOCKET NO: 03002649 FICilE: 55989 150 55989 154 RIDS: IE07 9103190263 Responds to 901218 Itr requesting written assessment of offcctiveness of meetings designed to improvo communications between licennee-& director of orc of quality mgt.

FROM: GROBE,J.A. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 910308 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9103199263*

. TASK: ODID: 34-00466-01 DIN: DPN - * .DRN:

DOCKET NO: 03000394 FICllE: 57090 076'57090 092 RIDS: 1807 y -g,.-wr,, + - . , y m ,---r ,w- 3c-,... , ..---.,_m.-e..- %,- , ,.w -

,.%,#,.m~. , .---,m r- e .m.<- . . . -

~r-a ,

d.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9105300050 Confirmatory of action ltr re 910520 telcons concerning activities following discovery of contamination event involving Ph-32 that occurred on 910516.

FROM: DAVIS,A AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 910521 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9203060423A -

-TASK: ODID: CAL-RIII-04 DIN: DPN DRN:

DOCKET NO: 03002649 FICHE: 60899 007 60899 008 RIDS: IE07 9106140190 Revised Confirmation of Action Ltr CAL-RIII-04A. Understands

-that licensee will not use licensed matls in Lab NC1-140' until listed actions taken,per 910605 telcon.

-FROM: DAVIS,A.B. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 910606 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT- FPAC: 9203060423A TASK: ODID: CAL-RIII-04A DIN: DPN: DRN DOCKET 03002649 FICHE: 60899 023 60899 023 RIDS: IE36

____..__NO: ......... __.___........................___

9107080204 Informs that completion of tasks & submission of results re 910516 investigation of contaminotion event,ccrrective actions to prevent recurrence & results of personnel exposure evaluations satisfy requirements.

FROM: DAVIS,A.B. AFFIL: NE R3

-tot. LOOP,F. AFFIL: EMDCLEV' ISSUED:' 910628 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: -'9109180235*-

TASK: ODID: EA-91-084 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 58389 200 58389 214 RIDS: IE07

t

[

l t

U.S. ITUCLEAR REGULATORY COMMISSION

HUDOCS PARTI AL RECORD FORMAT REPORT [

9107160345 Forwards insp rept 30-02649/91-01 on 910518-0618. Violations

. noted & being considered for escalated enforcement action.

FROM: NORELIUS,C.E. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 910711 AVAIL: PDR 2pp. -DOCUMENT TYPE: CLOUT FPAC: 9109180235A f

TASK: ODID: EA-91-084 DIN: DPN DRN:

DOCKET NO: 03002649 FICHE: 59261-143 59261 172 RIDS: IE07 P

9108020018 Forwards Enforcement Conference Rept 30-02649/91-02 on 910715 re apparent violations & concerns noted during 910518-0618 insp. Decision re enforcement action will be sent -

via separate correspondence.

FROM: NORELIUS,C.E. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 910725 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9109180235A l t

TASK: ODID: EA-91-084 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 59261 191 59261 229 RIDS: IE07 i

9108050013 Discusses insp rept 30-02469/91-01 & forwards notice of violation & proposed imposition of civil penalty.

i-FROM: DAVIS,A.B. AFFIL: NE R3

.TO: LOOP, F . . AFFIL: EMDCLEV-ISSUED: 910729 _ AVAIL: PDR 5pp. DOCUMENT _ TYPE: lCLOUT- FPAC: 9108050013*

TASK: ODID: EA-91-084 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 58634 030 58634 041 RIDS: IE14 b

.e.g. ,y.-y .,..,..,--.m.n--- -,-_p,,y.,,7., ,,,my,,,y w, . . ,r7..,.._..,___,,,.._g.____

7,,b.- _ _ , . - ,n ,-. ..# ,c,_ ,. ,-s.%,, .e.,ow. ,

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 9110170178 Ack receipt of 910829 & 0924 Itrs & $7,500 check for payment of civil penalty proposed by NRC on 910729. Corrective actions examined during future insp.

FROM: LIEBERMAN,J. AFFIL: -NE SEN To: LOOP,F. AFFII.: EMDCLEV ISSUED: 911011 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9110170178#

TASK: ODID: EA-91-084 DIN: DPN: DRN: ,

DOCKET NO: 03002649 FICHE: 59373 045 S?3- 045 RIDS: IE14 ,

?

9112310021 Ack receipt of 911014 & 1115 ltra submitted to show !

compliance w/ condition 21 of license. ;

FROM: GRODE,J.A. AFFIL: NE R3 TO: KEYS,T.F. AFFIL: EMDCLEV ISSUED: 911218 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9112310021*

TASK: ODID: EA-91-084 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 60130 075 60130 105- RIDS: IE07

' 9201310028 Confirms 920121 telcon agreement w/WH Schultz concerning receipient serving as medical consultant to NRC to evaluate individual involved in incident described in enc 1.

FROM: DAVIS,A.B. AFFIL: NE R3' :

TO: MIRALDI,F.D. AFFIL: EMDCLEV ISSUED: 920124 AVAIL: PDR- Ip. _ DOCUMENT _ TYPE: . CLOUT- - FPAC: 9201310028#

TASK:' ODID: 34-00466-01 DIN: DPN: DRN: :

DOCKET NO: 03000394 FICHE: 60413 101 60413 102 RIDS: IE07 9

7-~-..-_<,.,n, , ...w,..-..my ,,v.. .,~,._m ..r,... ..,,,..,_.,m,y ,..m...,.m.,.,. , y... ,.,___,ms-..4.~,o

U.S. NUCLEAR REGULATORY COMMISSION NUDOCS PARTIAL RECORD FORMAT REPORT 1

9203160194 Advises of reevaluation of Miraldi assignment to evaluate misadministration that occurred at clinic on 920117.

Concludes that F Miraldi is independent & appropriately ,

qualified to complete evaluation of medical effects. ;

FROM: GROBE,J.A. AFFIL: NE R3 TO: KEYS,T.F. AFFIL: EMDCLEV ISSUED: 920310 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9203160194*

TASK:

ODID: 34-00466-01 1 DIN: DPN DRN DOCKET NO: 03002649 FICHE: 60911 324 60911 327 RIDS: IE07 9204070016 Forwards insp repts 30-02649/92-01 & 30-17931/92-01 on 920128-29.No violations noted. Listed areas of concern, including faded color on Cs-137 sources identified. '

FROM: SCHULTZ,W.H. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 920326 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9204070016*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03017931 FICHE: 61228 157 61228 164 RIDS: IE07 9204230044 Ack receipt of 920312- submittal showing compliance w/

condition 21 of license 34-00466-01. Condition requires that licensee submit monthly rept re radiation safety program.

Submittal satisfies requirements & acceptable, FROM: GROBE,J.A. AFFIL: NE R3 TO: KEYS,T.F. AFFIL: EMDCLEV ISSUED: 920416 AVAIL:'PDR: 1p. DOCUMENT TYPE: CLOUT FPAC: 9204230044#

TASK: ODID: EA-91-084 DIN: DPN: DRN:

DOCKET-NO: 03002649 FICHE: 61395 173 61395 173 RIDS: IE07 4

* $ r r- *--1' <*C-r:-'**'-= er vr=-*- '---r wr*"*e ~ " " - " * * * - - *- w---* * +~-~'w~*--* *- * * - = ==*re--=*~--i-*=--~**

w/

i l

l l

U.S. NUCLEAR REGULATORY COMMISSION l NUDOCS PARTIAL RECORD FORMAT REPORT l l

9205190182 Ack receipt of 920417 ltr informing NRC of steps taken to correct violations noted in insp rept 30-02649/92-01.

FROM: SCHULTZ,W.H. AFFIL: NE R3 TO: LOOP,F. AFFIL: EMDCLEV ISSUED: 920508 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9205190182*

TASK: ODID: 34-00466-01 DIN: DPN: DRN:

DOCKET NO: 03002649 FICHE: 61706 148 61706 148 RIDS: IE07 9206180333 Discusses safety insp of license 34-00466-02 on 861120-870210. Violation noted.Insp conducted to review circumstances surrotoding teletherapy misadministration that occurred in Oct 1986.

FROM: HIND,J . A. AFFIL: NE R3 TO: KISER,W.S. AFFIL: EMDCLEV ISSUED: 870212 AVAIL: PDR 2pp. DOCUMENT TYPE: CLOUT FPAC: 9206180321A TASK: ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 62105 026 62105 031 RIDS:

9206180377 Partially deleted ltr re Cleveland Clinic Foundation furnishing incorrect info concerning teletherapy misadministration at clinic during Nov 1986.

FROM: WEIL,C.H. AFFIL: NE R3 TO:

AFFIL: EMDCLEV ISSUED: 890130 AVAIL: PDR 1p. DOCUMENT TYPE: CLOUT FPAC: 9206180321A TASK: ODID: 34-00466-02 DIN: DPN: DRN:

DOCKET NO: 03000394 FICHE: 62105 077 62105 077 RIDS:

_

ML20127C403

Text

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