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I'y MATERIALS LICENSE >

gi ,.y Pursuant to the Atomic 1:ncry) Ad of 1934, as amended, the i nery) Reorgantiatum Act of 1974 (Pubhc Law 43 -430, and Tole 10.

3f Cale of I cdcral Rcrulanom, Chapter I, Pani 30,31, 32,33, s4,33, 3% 40 and 70. and m rehanse on st.arments and repicsentanom heretofore p1, made by the hicocc. a h6 cme n herebs inued authoruing the hermee to artene, asquire, geweu. and tramftr byproduct. murce. and sinial p1| nuclear material deuynated tvlow. to us u h matenal for the puqusen, and at the riscal deurnated below. to delnct or tramter unh maictial I.

f to per*om authon/cd to recene it m ac5oid .nc with the regulattom ci the npphsable Pana)Thn liseme shall be deemed to tontam the ionditiomy spccined in Section 183 of the Atonuc fnnry Ad of 1954, e amended, and n subject to an apphrable rules, scrulanom anJ orden, of the hicar yj Regulatory Commiuion now of hereaf ter in cifect and to ati) tornhtsom siw died below. g1 pL3

_ ..____ _ _ ___. _ . . _ _ _ _ _ _ _ . - ,Licemee,

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fL Cardiology A>>veiotes vf 3. License number il-26237-01;f[ Dirminghali, P.C.g

i 't1 1 32270 Telegraph Road. Suite 100 .p!i

lj 4. Cspiration date Deceuber 31, 1995 gt .J ,_ . _ _ _ . _

T 5 D"d e t * 030-3i887 >

lj 6. By product, source, and/or=

Reference N.o1 _._ _ _ _.

b. Mastmum amount that hcensee i7. Chemisal and/or phyucal__ _y

l special nuclear matenal form may possess at any one time Ii

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!A A. Any radiophonndceutical A. As nteded I

f.Anybypruductmaterialidentified in 10 CFR 35.100 identified in 10 CFR 35.100 (l ii B. Any byproduct material B. Any radiophornoceutico l B. As needEd i1 identified in 10 CfR 35.000 icentified in 10 CFR 35.200 g

1; (excluding Xenon-133) i1

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y! ',1 l1 A. liedical use described in 10 CFR 35.100. g1 'if B. liedical use described in 10 CFR 35.200 (excluding knon-133, generators, and s

aerosuls).|

| - - - _ . . - - - - . . - - - - - - - - - - - - - - - - pg- _ . - _ _ - _ _ _ . _ g1 i410. Location of Use: 32270 Telegraph Road, Suite 100. Diruinghou, liichigan. t1 I

f| 11.Rodiction Safety Officer: Marc Steven Broddy,11.D.

| |g; 12. Authorized Users: y

(! II! Marc Steven Brodsky, M.D., f or uoteriols in 10 CFR 35.100, and 35.200 (liutted to :-

I cardiovascular procedures). 't,

| |VI' The licensee shall uaintain records of infonation iuportant to safe and effective {h| 13.

decos,u,,issioning at 32270 Telegraph Ruad, Suite 100, D1ruinghau, Micnigen per the y!

| provisions of 10 CFR 30.3b(g) until this license is teruinuted by the yli Cumuission. tI! |IM(l I' / ,1

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14. This-license is bohed on the licensce's stotements and representotions W' ,

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A. ' Application dated August 28, 1990, (with uttochuents except request fur grant i;"

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fDate: J u g e g _ _ _ _ ,, _ _ _ _ _ _ _ _ jjOctuler 29 d 990 by Johg_Dngj 11oterials Licensing bection, Region 111 |pgi

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O: (FOR L5MS USE): INFORMATICN FRCM LT5()

SETWEEN: *-------------------

() LICENSL FtE FANAGEMENT BRANCH, ARM : PROGkAM CODE: .....

AND : STATUS CODEt 3REGICNAL LICENSIf4 S EC TICN$ : FEE CATEGORY: .. ______...........

: EKP. DATE: 0() : FEt C O MME N15 ::::::::::::!!:: !!!::::::::::::::::::

OLICENSE FEE TRAN$MITTAL

() A. REGION

1. APPLICATION ATTACHED

() APPLICANT / LICENSEE: C AR DIOLCbY ASSOCIATES OFRECEIVED CATE: 130904C3CKEY NO: 3031887

() CONTROL NO.: 390142LICENSE NO.:AC T I ON TYPE: NEW LICENSLE

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2. CORRECT FEE PAID. AFPLICATICN MAY BE P4CCESSEC FOR:

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Cardiology Associates of Birmingham, P.C.ATTtJ: Steven M. Korotkin, M.D.32270 Telegraph Road, Suite 100Birmingham, MI 48010 j

Gentlemen!

Enclosed is your 11RC License No. 21-26237-01 in accordance withyour request. This licenso is issued concurrent with amendment No.06 to NRC License No. 21-20152-01, removing the facility located at32270 Telegraph, Birmingham, Michigan from Dr. Fentons 11conne.

Pleaso note that contrary to your request, you aro Ignuhosl to.

comply with 10 CFR Part 35.120 and 35.220 Possession of survey '

instruments. Exemptions of this nature can not be granted withouta review and approval of HMSS NRC Headquarters. In accordance withour discussions during a conference call on October 23, 1990 withyour. consultant Ms Tracy King, rather than delay the issuance ofyour licenso we are, issuing the licenso without the requestedexemption. However, if you wish to pursue this issue at a futuretimo, you may - request an amendment to the license. You shouldinclude all relevant supportive information and data with yourrequest. Your request will be forwarded to HMSS NRC Headquartersfor review.

Af ter review of your licenso we have determined that the type,form, and quantity of - material authorized does not warrant thedevelopment and submittal of a - decommissioning funding plan, orcertification of financial assuranco as described in 10 CFR 30.35(onclosed). However, this does not relieve.you of record keepingrequirements relative to information which the Commission considersimportant to decommissioning. Thorefore, we have added licenseCondition 13. requiring that you maintain such records as sot' forthin Section 30.33(g).

Please review the enclosed document carefully and be sure that youunderstand all conditions. You must conduct your program involvingradioactivo materials _ in accordanco with the conditions of your No.C-licenso, representations-made in your license application, and NRC'regulations. In particular, note that you'must:

I 1.- Operate-in-accordance with NRC regulations 10 CFR Part 19," Notices, Instructions and Reports to Workors; Inspections,"10 CFR Part 20, " Standards for Protection Against Radiation,"and other applicable regulations.

2. Possess radioactive material only in the quantity and form| indicated in your licenso.

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.. . _ _ . _ _ _ _ _ . _ _ _ _ _ _ _ . _ _ _ _ . _ _ . _ _ _ _ _ _ _ _ _ . _ _ .

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Cardiology Associates 2;

4

3. Use radioactive material only for the purpose (s) indicated inyour license.

4. Notify 11RC in writing of any change in mailing address.

5. Request and obtain appropriate amendment if you plan to change 1

ownership of your organization, change locations ofradioactive material, or make any other changes in yourfacility or program which are contrary to your licensoconditions or representations made in your license applicationand any supplemental _ correspondence with NRC. Any amendmentrequest should be accompanied by the appropriate fee specifiedin 10 CFR Part_170.

6. Submit a _ complete renewal application with proper fee ortermination request at least 30 days before the expiration '

date on your - license. You will receive a reminder noticeapproximately 90 days before the expiration date. Possessionof radioactive material after your license expires is aviolation of NRC regulations.

7. Request termination of your license if you plan to permanentlydiscontinue activities involving radioactive material prior toyour expiration date.

You will be periodically inspected by NRC. Failure to conduct yourprogram in accordance with NRC regulations, license conditions, andrepresentations in your license application will result inenforcement action against you in accordance with the GeneralPolicy and Procedures for NRC Enforcement Actions, 10 CFR Part 2,Appendix C.

If you have any questions or require clarification of any of the.

above stated information, contact us at (708)790-5625. I

Sincerely,

original Signed ByJohn D. JonesMaterials Licensing Section

Enclosure:1. License No. 21-26237-012. 10 CFR Part 303. 10 CFR Part 35

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CONVERSATION RECORD 3, wp <.y u /so

TYPE / noUTING

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CONVERSATION RECORD M10"At ronna tri 02-7s:son t-so :* m. a.* n 7 s ... u :DEPARTMENT OF DEFINtt

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k CARDIOLOGY ASSOCIATES OF DIRMINGHAM, P C.3???0 feiegraph n.1

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Stewn M Kmstkn M O. FA C C Mwc S [MM y, M D

July 11, 1990

UNITED STATES NUCLEAR REGULATORY CORMISSIONRegion Ill, Office of Riterials Licensing799 Roonevelt RoadGlen Ellyn, IL 60137

Re: New License Application

Enclosed are an applic ati on for a liy-Pr oduc t Riterials License for CardiologyAssociates of Birmingham, P.C. and an amendment for License No. 21-20152-01.

The facility, Cardiology Associates of Bir mingham, P.C., is currently a secondaddress of use on NRC License No. 21-20152-01. The amendment enclosed is toremove the f acili t y Cardiology Associates of Birmingham, P.C. from License No.21-20152-01.

We ask that the effective date of the new 1icense for Cardiology Assoclatesof Birminghan, P.C. and the amendment to License No. 21-20152-01 coincide.

A check for the $570 application fee is enclosed.

If you have any questions regarding this license application or the amendment,please cont act our consultant, Tracy King, at (313) 662-3197.

Thank you for your cooperation in this mat ter.

Sinc rjf y, '}|| $Ii j

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v /Presiden t/Xdnlini st rat orCardiology Associates of Birmingham, P.C.

Enclosures

RECED "SEP 041990

REGION in

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_. . . . _ - . _ _

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TEL.FARMDROOK RADIOLOGY,29829 TELECH APH RD.. SulTE Lt03

SOUTHFIELD MI 48034

1383) 352 9525

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July 16, 1990

UNITED STATES NUCLEAR REGULATORY COMMISSICHRegion III, Office of Materials Licensing799 Roosevelt RoadGlen Ellyn, Il 60137

Attention: Bill Adam, Ph.D.

RE: Amendment to License NO. 21-20152-01

The purpose of this amendment is to remove the facility locatedat 32270 Telegraph, Birmingham, Michigan from License No.21-20152-01. 1

This facility (Cardiology Associates of Birmingham, p.C.) isapplying for their own NRC License on the enclosed application.The radioactivo scaled sources located and used at this facilitywill not be transferred to any other location. Hence, aclosc-out survey'of this facility will not be performed.

We ask that this amendment be issued pursuant to the issuance ofthe license for Cardiology Associates of Birmingham, P.C. at32270 Telegraph Road, Birmingham, Michigan. In this manner, wehopc- to make the transition betwoon licensos withoutinterruption of normal clinic operation.

If you have any questions concerning this amendment or thelicense application included, please contact our consultant,Tracy King, (3130 662-3197.

Thank you for your cooperation in this matter.

Sincercly,.-

,

Rogof[6.Fonton,D.O.'

RBF:yEnclosure

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Cardiology Associalps of* Birmingham, P.C.' '

APPLICABILITY TABLE

4

litm lepic'

8.1 Training Program Enclosed

8.2 Other Training Program N/A |

9.1 Facility Diagram & Equipment List Enclosed

9.2 Survey Instrument Calibration Per 10CFR35.51

9.3 Dose Calibrator Calibration Enclosed

9.4 Personnel Monitoring Program Enclosed

9.5 Mobile Imaging Equipment QA N/A

9.6 Other Equipment and facilities N/A

10.1 Radiation Safety Committee N/A

10.2 ALARA Program Enclosed

10.3 Leak Test Per Appendix H. RegulatoryGuide 10.8, Revision 2

10.4 Safe Use of Radio 9harmaceuticals Enclosed

10.5 Spill Procedures Enclosed

10.6 Ordering and Receiving Enclosed

10.7 Opening Packages Enclosed

10.8 Unit Dose Records Enclosed

10.9 Hultidose Vial Records Enclosed

10.10 Mo 99 Concentration Records N/A

10.11 Implant Source Use Records N/A

10.12 Area Survey Procedures Enclosed

10.13 Air Concentration Control N/A

10.14 Radiopharmaceutical Therapy N/A

10.15 Implant Therapy N/A

10.16 Other Safety Procedures N/A

11.1 Waste Disposal Enclosed

11.2 Other Waste Olsposal N/A

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Cardiology Associates of Birmingham, P.C.,,NRC Licen:;c RequestJuly 1990

'.

RAD 10AC11VE KA1LRIAL AND USE

ltem 5 Item 6flyproduct_aterial lim 03nt Euft2212M

Material in 35.100 As Needed Uptake, dilution, and excretion studies

Material in 35.200 As Needed Imaging and localization studies

for purposes of cardiac studies only.Excluding generators, radioactive gas, and aerosols

RADIATION SAFETY PROGRAM RESPONSIBILITY

ltem 7.1Autho_rized Users daterialsMarc S. Brodsky. H.D. 35.100 and 35.200

Item 7.3Radiation Safety Offictt

Marc S. Brodsky H.D.

Dr. Brodsky's preceptor statements are enclosed.

;

_

. _ - - _ - _ _ _ _ _ - _ _ _ _ _ _ _ _- . ____. -__- - _ - - _ - _ _ _ . _ . - - _ _ - - _ - - _ _ _ _ _ _ _ _ _ _ _ _ - _ - _ _ - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _.

*.. 1' '

'

., .= |*

.

t .NHC FORM 313M SUPPLEMENT A U S. NUCLI Afl llEbEh1OftY COMMISSION' '

TRAINING AND EXPERIENCE ^"|,'f'g |'' """,

AUTHORIZED USER OR RADIATION SAFETY OFFICER r nim o 30 no |

1 N AMt OF AUTHORIZE D USC H 04 H ADIAfiON S AFETY OF FIC(n 2. ST A1( Oft TIHH110HV INWHICH LICE NSL D f OPH ACTICE Mi DICINIf|rM.c

,

~ I.1"i (;p"w / ; %, n; I-

.

[' t , , r o i r, as s 13. CE HilF ICATION

$PECI ALTY BOARD CAftGORY MONTH AND YE AH CE Hilfit DA B C

h |f**Tu(art [ (uf' kn T~It' Yt!! t//\C $'lY' $G /{nerihm frerd c(' /&vtv] /*'rda i c.- tJtv. I?E9(bndrwiubr ih% qra

I4. TH AINING HECEIVED IN DASIC H ADIOlSOTOPE H ANDLING TECHNIQUES |

T YPE AND LENGTH OF TH AlNING'LECTunt/ suPr ftVISE D '

FatlO OF THAINING LOC AflON AND D A TE (55 OF T H AINING LA00HATORY LABORATOHYA B COURSES E MPE ale NCE ctuovost (Hotren t

C D

( G.!!u an jb.,ur-+ 't !h ' jn Y ' /-

.

a H ADI ATION PHYSICS AND / ti, 3 / f |, /' t , ' l i (,5 r i h f''

i

INST RUME N T A TION-t/, f/ / hl ui / - ,kn '

2k |Oti. RADi A1 ION Pno1EcTioN "

__ __ _. _,

c M ATHf M ATICS PE RT AINING TOTHE US( AND ME ASUHf M[ NT I /OOF RADIOACTIVITY

._ - __

tt 4 ADI ATION BIOLOGY -

v') V 7N''

w ~

_ _ _ _ _ _ _ _ __ _ . _

e, A ADIOPH ARM ACE U1|C ALC HE MIS 1 R Y

,{-

5. EXPEn|ENCE WITH RADI ATlON. IActualuw of Radiossatoors or Equivalent Eweriencel

ISOTOPE M AXIMUM AMOUNT WHEnt EXPERIENCE WAS G AINED DURATION OF f XP(HIENCE TYPE OF USE

[de Tj!h7 ev) b[O rb !f'['' l4 f O \044' ' IU'" II

\ C 't

ns y it l'

[ ll' 1GI Y m Cs '' "

!

- -

_ _

!I (. /\( c ( \

NHC F O[tM 313M Supplement A19 81) P89* 5 M E k. 90142

. .- _. -- - - - -

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ - - - _ _ --_ - _

*,.

.- d.

.

9 NHC FonM 313M SUPPLEMENT H U. S. NUCLE AH HEGUL ATORY COMMIS$10Ny 811 Approved by OMB

t 3 tS00M 1PRECEPTOR STATEMENT tapetes 9 30 B6

Supplement B mus t le canpleted tv the apphcant physician's preceptor. I1more than one prs ceptor os necessary to dccumentesperience, obtain a separate statement fran each.

1. APPLICANT PHYblCI AN'S N AME AND ADDRf SS KEY TO COLUMN CP VLL N AMg PE RSON AL PARTICIPAflON SHOULD CONSIST OF

16upervoted enaminateun of patients to detevenine the tuttability f oftedioisotope d.agnosis and'or treatment and #econvnendation f or

Marc Steven Brodsky p,etc,it,d dotag,.

5T RE E T ADDHL SS?<ollatneation in done calsbration and actual admmistration of dose

to the patient including calculation of the radiat on dose. related32270 Telegraph rd., Suite 100 rweiuvementi er s piotimg of daia.

Cli V | sit A t t | ZIP CODt 3.Adtnauste period of teanning to enabie physician to manage radioactivepatients and f ollow pr,tsents through diagnosis and/or course of )t r eat tren t . 1

nirmintham MI 48010 l

2. CLINICAL TRAINING AND EXPEHIENCE OF ABOVE NAMED PHYSICI ANNUMBER OF

C ASES INVOLVING COMME NT SISOTOPE CONDITIONS DI AGNOSED OR TRE ATE D PE HSON AL /Acscr,tional mtormatson or comments mn

PA R TICIP AT10N te sutvn,tted m stupheste on separea* shernJA B C D

DI AGNOSIS OF THY HOID FUNCTION

00 TE RMIN ATION OF BLOOD ANDDLOOD PL ASM A VOLUME

1 131 LtVE H F UNCTION STUDIE Sor

1125 FAT ABSORPTION STUDIES

KIONEY FUNCTION STUDIES

IN VITHO STUDIES

OTHER

| 125 DE1ECTION OF THROMDOSIS

1 131 T H Y A OID IM AGIN G

P 32 EYE 1UMOR LOCAll2 ATION

Se 75 P ANCDE AS iM AGING

Y tr 109 CtSTE RN OGR APH Y

BLOOD FLOW S10 DIES ANDp g33PULMON A RY F UNCTION STUDi[S

OTHEH

BR AIN IM AGING

(J[j,j) '$ ) 3gHDI AC (M AGIN G

T H YROID IM A Gt N G

SALIV ARY GL AND 4M AGING

Tc-99m BLOOD POOL iM AGING

PL ACEN T A LOC All2 ATION

LIVE H AND SPLE E N IM AGING

LUNG IM AGING-._ _ _ _ _ . .

BONE IM AGING

] ||j ym fgwgg(, f 5 C*OTHEH

NRC FOHd 313M SUPPLEMLNT B l'

19 811 Page 6

F I T,' a,

,

0, $ ' O *. .o

$ PRECEPTOR STATEMENT IContinued/,

2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN ICastinueJ/MUMbt FDF

C ASE s lNVOLVING COMME NT S

ISOTOPE CONDITIONS DI AGNO$E D OR THE A1E D PE l. SON AL (A#defewlet en formation tv tomments mer twPARTIClPATlot* wkmoted on Gr otse on soposett W.te tLio

A B C D

P 37IS D'*'I .

TRE ATMENT OF POLYCYTHEMIA VER A,LEUKEMIA. AND BONE METASTASES

HE AWEU(Co de'l

TRE ATMENT OF THYROID CARCINOMA1131

TRE ATVENT OF HYPERTHYROIDISM,

Aw.198 INTR AC AVIT ARY TRE ATMENT

*C o GQ 6NTE R$14TI AL TRE ATMENT

onC&l37 INTH ACAVIT ARY TRE ATME NT

41?bo, INTERSTifl AL TRE ATMENT

l#-192YloO

o' - TE L ET HE RAPY TRE ATME NT '

Col 37

$s90 TRE ATMENT OF E YE Ol$E ASE f

R ADIOPHARMACEUTICAL PREPARAllON

f,'9[[9 /hGENERATOR

y ,' 3''

GENERATOR *

*Tc9Dm RE AGENT KITS /pOihee

.

4

.

3. DATES AND TOTAL NUMBER OF HOURS RECElVED IN CLINICAL RA0lOISOTOPE TRAINING

Jun / ~3Tn n 3 / , f rl? O ~) ~'

w JO bo"6 -,

l ( stg-

4 THE TRAINING AND EXPERIENCE INDICATED ABOVE PR M PT %IGN A T LlH \| WA$ OBTAINED UNDER THE SUPERVISION OF:

Q3,. 'W} 4<\)MF1/ j

r a juaut os sues avison IN#

Cheryl Culver. Q , .. g n. ~h !A u _ |_ #u saut os insteivtioN t PR'E'CEPTOk5 k AME (PiraM rype os print)

.

-

LU,$o m 7G m ,,m O //ve ,dhfc. uani*,oaooatss '

Itoward Dworkin, MD%DI w . 1 4, p r. |e j'd .

,

o ts t v. ; AIE'D18

b / (A li, h,c4 no a 00h M la 001425. M A iTIIi/4 5.5 L IC E f..d. te uM C ' 4 :54

2/ - C/ ,3 3 3 ' / bhO d} D'7 ot49 Nrt( 313 M su PtE Yt,N T Dr

*(6 7M

l~ . a a . :. -- . _ - . . -- a

_ _ _ _ _ _ _ _ . _ _ - - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _

.

*.

e

6

e onu NRC 313M LUPPLk ML N1 A*

' ' ' * U.5 NUCLL Ah RL GUL ATOMY CCMMl?SIONTRAINING AND EXPERIENCE

AUTHORIZED USER OR RADIATION SAFETY OFFICER

1. Naut 08 AU1MChillD U$l4 om M ADI ATION 8 AttTY Of f ecim t gt AT! On Tg antiony NWMiCH LittN5(D TO |Marc Steven Brodsky, M.D. ' ' ' ' ' "

M l) Ci hiiF !C A TION

6*tCI ALTv 60 AMD CAftcomyMONTM AND vs As ct RTitetoA e C

1. A merican Board of Sept.1986Internal Medicine

2. American Board of tiov.1989Internal Medicine Card-in v r e n1, r DEearer

4. TR AINING RECT tVf D IN Basic RAD 10110 TOPE HANDLING TE CilNIQUES

TYPE A.N D LING TH OF T R A4NINQ

Lretunt s svet avistoFit LD of TMAsNINGLOC A TION AND Daft (El oF T A AikiNO L A 90m AT0m v LADOMATORYA e counsts sarcatsNCt

enega tungaNo formalized 4Y og pro-

.. n Aoi AfioN Pwv5ics ANo gra m .in the c of riuclear.

INST R Uut NT A ttoN Medicine of the ClevelandChum 11 u o c am -

m. M ADIAT40N PROTECTION

s. M ATHtuatics PE RT AINsNG TO*THE V$t AND ut Asums utNT08 m AD10 ACTIVITY

-

e. naci ATioN stotocy

e m AoiopM Amu Act VTICALCHt utST R Y

5. EXPERIENCE wtTH R ADI ATION. lActuotuse of Rottioisotopes or Eevivelent Coverrencelisotoot i M Axtuuu ApovNT j wMe at g rrr.astNet wAs o Ashto l Ovn AtioN os ExPtmetNet Tyrt of ust

T1-201 2-3 mci Cleveland Clime 5 monthe y CunicalR b-82 - 40-60 mCl I month

~

Clinical" ",

Tc-99m ~ m' o ArRAC 20-30 mCl 5 months" " ^ ' ' C]InicalTc-99m

DTPA 10 mci 5 montha Clinical" "

Tc-99mPYP 10-15 mci 5 months Clinical" "

8Om u NRc.Jt3M $woper s.;AN ?st

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

F ,

.

..

. .

.-.

,cau N RC.312M;$UPPL! MENT BU. L NUCLE AR REGUL.ATORY COMMIT 340Nte rst

PRECEPTOR STATEMENT

:,,,mie.meer a mvst ce eamoretre ov tw worseetonysica, s orveroton teme, snw <rw orresomr s rwes.ory w oueumentanor i nce, oown o severoer een ement tam een

t. AroucANT *Nvsici AN s N Aui ANu aconasa | KEY TO COLUMN C,m ,,,,, et Mecov AL e ARTitre ATioN swovLo eoNasi ori

i.s.us.. .a.a .e Ni. in su n,,#w

r . ..wi.=Marc Steven Brodsky e nm.v m .a ., u. .ai.a. .n ,u.a...ew

...s e m * * *ooas** j

24.n.,.. .n . .a.. ... ....,~W70 Teleareph Rd. , Suite 100* * '.". wi'.a' ==w e ae .=m.'.=.' *a .o" r***iaa aa . r.. =*

;

s. . . . .

g, , , i arr a a 4 ai. c oc,a-

3 Aa==='. a ras. ' .i'..a ae to .. o'er==.a 'v. maa.e.r.a amne .mi. .. .a i.i . . . m, a ..c . .a == .eBirmingham MI 48010 " " ' ' " * " - , ,

. 2. CLINICAL TRAINING AND EXPERIENCE OF AS9VE NAMED PHYSICIANNUh.05R OF

cases Nv0Lyteeo Ct|mshetedTSBSOTCrt CONDITIONS DI AGNOst0 0A TRE AftD MR50NAL Mas,s,.nm meeanesean w.owmas saarP AR TICap A TIONer asemetes a e, peas e an ase.r.e an.e.L/A B C O

Di AGNClis OP TMvm010 FUNCTION

ot t1RulN ATICh Ge7 4.OCQ Are0 tOLOOD PLASM A VOLUME I

l.13% uvt R PUNCTION STV0st8 |w613 P AT assoRPfl0N ETVolt S |

stlONEY PUNCTlON STVOit$ |

th vif RC STUOtt$ |

CTHER |

n.126 - 08 ft C TION Op TH R OM B OSIS |

6 131 THYRO #0 tM A0iNG |

P 32 EY6 RAMOR LOCALIZ ATION |

S* * 4 - P ANCRs AS iM ACINC |

Yh=199 . C$tt RN OCR APHY |

ggy 186000 #LCMr 57UQatt AND 11 PULuoN a RY SUN 0Ti DN $ TUOtt S I

omem Rubidiu m - 82 myocardiall scan 10 Please see attached lettereR AIN iM AGIN G | for detail.

_ _,

k%Ch[gg ~gW"C ARot AC 4W AGING

THv ROI D iM AGI NG

SAuv ARY CL AND su AC6.dQ |T'*

_e coo ecol iu Ao.No |.

PLACENT A LQO AUZ AtlON |

uvtRANo$*uthiuAs No |

|LvNo MAc No ||

| - I sone iM AceNo

| ***'" | Thalliu m myocardial scan | ~ 1500! Foned NRC 3 tau 3UPPLiutNT $WW P.g. 6 g,V| u . ||, ,-

.u t jy* /.,

$-li

,-.e , . .n e - , ,..,,.,,.~-~-,,.w.-,..,,.,,--,.,.n,r,,.-,-,.--_.-,--.,,,,,,--n, w-~--- --w --- ~ - - =

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

*.'

.

. s.

..

.

.

| PRECEPTOR STATEMENT iContinutal

:. CLINICAL TR AINING AND EXPERIENCE OF ABOVE NAMED PHYSICI AN /C.virmueelNvwT1037

CASE 5 INV OLVING C.DuM E NTSISOTOPt CON 0ffl0NS DIACNost0 on Tat Atto P W oNAL hn,ma meme a m=as e ao

P A R TICIP A TION asem,res a a,e,ese og wearew ese at'

A e c 0PC | Tpt ATWINT QP POLVOYTMtulA Vf 4 A, |h A8'l | LEVEEMIA. AND SONE MtTA$TA$$$ |

,,, f INT M ACAvlTA RY T RE ATME NTg, ,

( TRE ATWINT CP THY MQlO CARCINOM A i4.t 31

TRE ATMENT CP MVPERTHYRCIDI$M f |

| |NTR ACAVIT ARY TME ATMENT fAv.19e

Ce40 | INTE RSTITI AL tdt AtutNT |C 137 | INTRACAvlTARY TMEA tut NT |

| INT 1RSTITI AL TRE ATutNT..1'eY | TTLETME RAPY TRE ATMtVTc.a. t 3 7

$ato | Tat ATwtNT OP IYt DICS Att |

| A AQlOPMAMMAClyTICAL PRtP ARAT10N |

T"[M | GENE A ATOR |

D',$ | CENERA704 |

Ts.99m | R$ AGENT ICITS {

ow

.

3. DATES AND TOTAL NUMBER OF HOURS RECEIVED IN CUNICAL RADIQl50 TOPE TRAINING

1) Oct. 20 - Nov.16,1986 Nov. 28 - Dec< 11,19882) Sept.14 - Oct.18,1987 Jan. 1 - Jan. 8, D89 N/W k3) M ar. 14 - A pr. 17, 1989 x4) J uly 1 - A u g . 14, 1988 d

4, THE TRAINING AND EXPERIENCE INDICATED ABOVE 6 ' RECEPTOR 138GNAWMEdWAS OSTAINED UNDER THE SUPERVISION OF: /J r e

a =aus os swee n vino n / gmS$ ( b M.Raymundo T. Go, M.D. /

6 ..ua oP i~sTirwtica ?. PatcaPton's NAME PWas We arpAmUCleveland Clinic Foundation Raymundo T. Go, M.D.

6 "^*"o****8" (Please see attached letter)9500 Euclid A ve. , 1 Clinic Ctr. Dr.a Ga T V 5. GA T E

Clevela nd , Ohio 44195rhaa;Au szNsa wMasais, Ja n . 17, 1989

34-00466-01comu senc.JiJusw *L4 ut N T er

g .. ,,'

.. ;'

e U A 00vtPmutmf reimMG Cf tect.4641 341743.3360 I898 7

- - - - - - - -

. !

f . '., l~

ej,

~ 5.

.

Ti 111 CLl X13. LAND CUNIC FOUNnNrlON% < u otan u n na- i u ri.ind i % u n u ,

!

.\ N 6(le ill.li lie irl t'.il ( Pillet \ll liitofi1.t(H ell il l le.tifle |(r*.i n til t' I

|{.n tiilllH 14 i l'. ( se S. \1 i ).4 n. nn n. in[ h '{ k ;ft|l te 14; t 4| M K h ' af \le e l;4 al u ' I d'.itas**Di H&3WG

'

January 17, 1989

To Whom It May Concernt|

,,

This is to certify that Marc Brodsky, M.D., a fellow of theDepartment of Cardiology rotated through-the Departnent of NuclearMedicine of the Cleveland clinic Foundation for a period of about4 months. From October 20 to Noventer 16, 1986 he was assigned

,

to nonitor the exercise stress part of Thallium imging. Septenber |14 tc October 18, 1987f March 14 to April 17, 1988, July 1 to I

August 14, 1988 and November 28 to January 8, 1989, he spent his!time participating in the interpretation of nuclear cardiac imges;

and cardiac functional measurements. In January, Dr. Brodsky|participated in the interpretation of several cases of Rubidium-82

PET myocardial perfusion images that were being correlated with'Ihallium-201 SPECT studies.

The following are the types and average nunbers of nuclearcardiac images and functional measruements that are perforned andinterpreted daily in our departnent:

1) Planar and SPECf Thallium-201 myocardial perfusion imaging (average1 case / day for the planar and average 14 cases / day for the SPECTimges) .

2) Tc-99m pyrophosphate myocardial infaret avid imging (average1 case /wk).

3) Nuclear first pass stress left ventriculogram (average 3 cases /wk).4) Resting nuclear first pass right ventricular ejection fraction

measurenent(average 2 cases / day).5) Resting gated left ventriculogram (average 4 cases / day).6) QP/OS first pass analysis for detection of left to right shunt

(average 1 case / month).

NMR 90142o,m... .,, m maa ."

. . - . ~ . . _yp g (le T id d W / ) L W 14. ds t , I W 1 g4 4

. - . , - -m. -,-,_w .. , , . . _ - . , . , , . , . . . . - , _ _ . . _ . . _ . . . _ . . . . _ _ . _ _, -,_m. ., . . _ .

(___._______ ____- _ _ _ _ _ _ _ _ _ _ _ -- _ _ _ _ _ _ - _ __ _ _ - _ _._-. _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _

o I>

..

. .e|,

.

.

1

During his rotation, Dr. Brodsky was extrenely conscientious |and interestod in Icarning this subsrecialty. Ile perforisd hisduties and responsibilities very well. Ills ability to interpretthe otudies is above average. I would rate ecce of. his dictationof the reports to be above average as well. Overall, Dr.Brodsky's performnce during his rotation was exceplary.

Sincerely,

#D* J tQ ,i

Raynundo T. Go, M.D.Chairnan,Departnent of Nuclear Medicine

erac/6nf

.

J

{

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i

T--w'T T''"'T T''re-

9e T'rm----murv'-Tw- ~v -c P -www m- yw-e----www-=& 4--- -9----Y--~<--'w " >=e - y e,7mesvW=r- y *4W#t*'f'--t'% y@ sey w W--h%d'NW 4

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . .

Cardiology Associates of Birmingham. P.C...NRC License RequestJuly 1990

,

.

PERSONNEL TRAINING PROGRAMltem 8.1Effffunft1

All radiation workers and ancillary personnel whose duties will requirethem to work in the vicinity of radioactive materials will receiveinstruction. Ancillary personnel ma include housekeeping, security,nursing, maintenance, and ECG technolo ists.

Iniaina freannu1. Before assuming duties with, or in the vicinity of, radioactive

materials.

2. During annual refresher training.

3. Whenever there is a significant change in duties, regulations, or inthe terms of the license.

Instruction Topici

1. Applicable regulations and license conditions.

2. Areas where radioactive material is used or stored.

3. Potential hazards associated with radioactive material in each areawhere the employees will work.

4. Appropriate radiation safety procedures.

5. The licensee's in house work rules.

6. Each individual's obligation to report unsafe conditions to theRadiation Safety Officer.

7. Appropriate response to emergencies or unsafe conditions.

8. The worker's right to be informed of occupational radiation exposureand bioassay results.

9. Locations where the licensee has posted or made available notices,copies of pertinent regulations, and copies of the license and licenseconditions, as required by 10CfR19.

Documentation will be kept on hand for review of the list of topicscovered, the date of the instruction, and the names of those attending.

. .-- .__ .. . . . - - . .- - . - . . - - - -

f14cro l,li

( .

.

.

l'ac ili t y Dia n t am .

IJCardiology Annociates of 111 r m i n glia m

__ /1

.

Strean It o o m s and llot Lab Area

ita ll i

_

"

Sliowc 1(ent Shower l> c a kllentroom room,,

t. . - T. '

,

!'

,

I Office| ;

-

I -

' s]J .c s , , t -. ,.

\*,

Treadmil i

I

,13hbni 6 I i n ,R oc. m . .. \

2. Contro

t>l i I,

q,97 - - - - ,=-

fio l y3 , _ .

! Codd y-

Shic -

re cit e r for lot 1) anteTreadmill- llo t 1ab / 1

| 1.c a dp g ,3 p,lans

I

'

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QDo e

q _

,._Ca ibr. Lint l,,-It i- ~ _ _

' '

lla } }

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b %e m Q,|l

..

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Facility Diagram

Cardiology Associates of B i r mi n glia m |0 ~~ Imagiur, lloom

h,f flin l l

I

]e;='

/?

Compute e

~s

!

i

i~D

J i i' 4- 6'l I S t re t elie r jOff1C0 .'. hu -

(0.,

Office,

Comme |Camer >

vCunaal s

:q -- -,,0,5),,_.. -

Exercluo Gym

. .

9 Pa, :0- 9, % ,,

' .. + W O.

;

_ . ~ . . _ _ _ . - _ . _ _ . - - _ . _ _ _ _ . _ _ _ . _. _ . _ . _ _ _ _ _ _ _ _ . _____ _ _ _._ _-___

_ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ __ - _ - _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _

Cardiology Associates of Birmingham, P.C...NRC License RequestJuly 1990

,

.

EQUllHENT LIST

ltem 9.1 (cont.)

Im191na Louinment Idamma Camera with computer |

|

Opse CalibrpigrCapintec CRC 7

Survey MettriBicron Surveyor 50 GM Meter, Range (0 0.5 mR/hr Lu;t Range)

(0 50 mR/hr High Range)

Please grant an exemption to 35.120 and 35.220. We use only unit dose atthis facility and do not foresee the need for a survey instrument whichexceeds 50 mR/hr.

Healih Phvi gi.lgttnmeal.. Leadglass 1 ace sh' eTdRemote handling toolsVial shieldsSyringe shividsLead shielding as necessary (i.e. bricks, containers,etc)Lead 11ned trash containers

:

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

__ _ _ . _ _ _ . _ _ . _ .- __ - _ _ . _ _ _ _ ._

Cardiology Associates of Birmingham, P.C..,

NRC License RequestJuly 1990

,

.

CAllBRATION Of SURVEY INSTRUMENTS

Item 9.2All surycy instruments will be calibrated and checked in accordance with10CFR35.51. Survey instruments will be calibrated by:

! 1. The manufacturer.

2. Medical Physics Consultants (NRC License No. 21-20153 01).

3. Any authorized user licensed to perform survey meter calibrations as a,

service.

|

:

|

l

!

i

._

r- i

Cardiology Associates of Birmiagham, P.C...NRC License RequestJuly 1990

,

.

CAllDRATION Of DOSE CAllBRA10R

Item 9.3

Test Freauency Tolerance

Constancy Daily prior to patient dose assays +/- 10%

Linearity Installation, following repair, and quarterly 4/- 10%

Accuracy Installation, following repair, and annually +/- 10%

CeometryDependence Installation and following repair +/- 10%

-lived reference sourceCONSTANCY testing will be performed using a lone,0(e.g., Cesium 137 with activity greater than microcuries. Zero orrecord the backgrou)nd reading on the appropriate setting.Assay the sourcefor both the reference source setting and the most commonly used

; radiopharmaceutical settings. Record the readings and compare to the'

calculated values. The Radiation Safety Off;cer will be notified and theunit will be repaired or replaced if the constancy error exceeds 10percent.

LINEARITY testing will be performed using a Technetium-99m source havingactivity at least as great as the maximum activity administered topatients. Testing will be conducted with the decay or the leaded-sleevemethod over the entire range of administered activity.

' Decay method: Assay the source at approximately 0, 6, 24, 30, 48,i etc hours over the entire range of use(between the highest activity

administered to patients and 10 uC1). Record the net activitie.time, and date. Using a measured activity for reference which isclosest to that which is commonly administered to patients, calculatethe expected readings- and compare to the measured readings. TheRadiation Safety Officer must rev ew and sign the test document. TheRadiation Safety Officer will be notified and the unit will berepaired or replaced or patient dosage readings will be mathematicallycorrected if the linearity error exceeds 10 percent over the range ofuse.

Sleeve method: The sleeves will be calibrated at the time of anintial reading of a decay-method linearity test. Either the

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"Calicheck" or "Lineator" product will be used and the testin'

! procedure will be performed according to the manufacturer'gsinstructions. The Radiation Safety Officer must review and sign thetest document. The Radiation Safety Officer will be notified and theunit will be repaired or replaced or patient dosage readings will bemathematically corrected if the linearity error exceeds 10 percentover the range of use.

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Item 9.3 (cont.) Page 2 oi' 2'

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ACCURACY testing will be performed using cesium-137 and cobalt-57 orbarium-133 reference sources having NBS-traceable activities greater than50 microcuries. The net measured activitics will be compared to the

! calculated activities based on radioactive decay. The Radiation SafetyOfficer must review and sign the test document. The Radiation SafetyOfficer will be notified and the unit will be repaired or replaced if theaccuracy error exceeds 10 percent.

GEOMETRY DEPENDENCE testing will be performed using a solution oftechnetium-99m having an activity concentration of 1-10 mci /ml. If

generators and/or radiopharmaceutical kits are normally used, both of thefollowing tests will be performed:

Unit dose users will assay 0.5 cc of the solution in a 3 cc )lasticsyringe. The solution in the syringe will then be diluted wita waterand assayed at incremental volumes of 1.0, 1.5, and 2.0 cc. Recordall readings. Select a standard volume closest to that normally usedfor injections and divide the activity by the other measuredactivities. If any error exceeds 10 percent, correction factors willbe applied to the appropriate volumes and a correction factor chartwill be applied to the dose calibrator. The Radiation Safety Officermust review and sign the test document. The Radiation Safety Officerwill be notified and the unit will be repaired or replaced or patientdosage readings will be mathematically corrected if the geometry errorexceeds 10 percent.

Generatgr/ kit users will assay 1.0 cc of the solution in a 30 cc glnsvial. The solution in the vial will then be diluted with water andassayed at incremental volumes of 3, 5, 7, 9, 11, 13, 15, 17, and 19cc. The assays should take place within 10 minutes. Rm rd allreadings. Select a standard volume closest to that normally ased formixing kits and divide the acti W y by the other measured activities.If any error exceeds 10 percent,' correction factors will be applied

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to the appropriate volumes and a correction factor chart will beapplied to the dose calibrator, lhe Radiation Safety Officer mustreview and sign the test document. The Radiation Safety Officer willbe notified and the unit will be repaired or replaced or patientdosage readings will be mathematically corrected if the geometryerror exceeds 10 percent.

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ICardiology Associates of Birmingham, P.C...


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PERSONNEL MONITORING PROGRAM

ltem 9.41. The RSO or delegate will promptly review all film or TLD exposurereports to look for workers or groups of workers whose reportedexposures are unusual.

2. All individuals who are occupationally exposed to radiation on aregular basis and may receive greater than one-tenth the quarterlypermissible limits will be issued a film or TLD whole body monitor.

3. All individuals who handle radioactive material on a regular basiswill be issued a film or TLD finger monitor.

4. All individuals who are occupationally exposed to significantradiation levels on an occasional basis, such as nurses caring forradiopharmaceutical therapy.or implant patients, will be issued a wholebody. monitor when caring for those patients.

5. Other individuals who are exposed to radiation on an occasional basissuch as security personnel who deliver 3ackages, secretarial personnel whowork in the nuclear medicine clinic aut do not work with patients, andnurses who occasionally care for patients who have received diagnosticdosages will not normally be issued exposure monitors.

6. All film and TLD badges will be changed on a monthly basis.

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-. Cardiology Associates of Birmingham,;P.C.. . -NRC License Request

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July 1990-,

MAINTAINING OCCUPATIONAL RADIA110N EXPOSURE ALARA_

ltem 10.2 Page 1 of 5-

-lhis license- is for an. out-patient diagnostic- clinic and,therefore, is not required to have a Radiation Safety Comittee.The statements following wnich refer to the Radiation SafetyComittee - will actually mean Radiation Safety Officer for thislicense. All ertinent responsibilities of the Radiation OfetyComittee will: e met by the Radiation Safety Officer witn the-

assistance of the radiological physics consultants.

1. Management Commitment-

a. We, the management of this medical facility, are committed to theprogram described herein for keeping individual and collective

reasonably achievable in accord withwe hereby describe an adm(ALARA),inistrative organization

doses as -low as isthis commitment,for-' radiation safety and will develop the necessary written )olicy,procedures, and intructions to foster the ALARA concept wit 1in ourfacility. The organization will include a Radiation SafetyCommittee (RSC) and a Radiation Safety Officer (RS0).

b .' We will perform a formal annual review of the radiation safetyprogram, including ALARA. considerations. :This will include reviewsof operating procedure:, and past dose records, inspections, etc.,and consultations -with the radiation safety staff- or outside -consultants.

.. Modifications to operating and maintenance. procedures and toequipment and facilities will.be made if they will reduce exposuresunless the cost, in our-judgment, is considered to be unjustified.We will -be able to demonstrate,; if necessary,-that improvementshave been sought, that modifications have been considered, and thatthey have been-implemented when reasonable, if-modifications have-been recommended but not implemented, we will be prepared to

-describe the reasons for not implementing them,

d. In-addition to maintaining doses to individuals as far below the-limits as is reasonably achievable, the sum of the doses receivedby:all exposed individuals will also be maintained -at the lowest-practicable- level .- It would not be desirable, for example, to holdthe highest doses to individuals to some fraction of the applicablelimit if this involved exposing additional people and significantlyincreasing the sum of radiation doses. receivedby:- all involved-individuals.

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Item 10.2 Page 2 of 5

b. Delegation of Authority

(1) The RSC will delegate authority to the RSO for theenforcement of the ALARA concept.

(2) The RSC -will support the RS0 when it is r,ecessary for theRSO to assert authority. If the RSC has overruled the RSO, itwill record the basis for its actions in the minutes of thequarterly meeting. '

c. Review of ALARA Program

(1) The RSC will encourage all users to review current proceduresand develop new procedures as appropriate to implement theALARA. concept.

(2) The RSC will perform a quarterly review of occupationalradiation exposure with particular attention to instances inwhich the investigational levels in Table I are exceeded. Theprincipal purpose of this review is to assess trends inoccupational exposure as an index of the ALARA program qualityand to decide if action is warranted when investigationallevels are exceeded.

Table I: IDyni_tgallonal levels

Level I Level IIBody Part Exposed (mrems ofr calendar cuarter)

1. Whole body; head and trunk; 125 375active blood forming organs;lens of eyes; or gonads

2. Hands and forearms; feet and 1875 5625ankles

3. Skin of the whole body 750 2250

(3) The RSC will evaluate our institution's overall efforts formaintaining doses ALARA on an annual basis. This review willinclude the efforts of the RSO, authorized users, and workersas well as those of management.

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'.Item 10.2 Page 3 of 5

3. Radfation Safety officer

a. Annual and Quarterly Review

(1) Annual review of the radiat on safety oroaram. The RSO willperform an annual review of the radiation safety program foradherence to ALARA concepts. Review of specific methods ofuse may be conducted on a more frequent basis.

(2) Quarterly review of occupational exoosures. The RSO willreview at least quarterly the external radiation doses ofauthorized users and workers to determine that their doses areALARA in accordance with the provisions of Section 6 of thisprogram and will prepare a summary report for the RSC.

(3) Quarterly review of records of radiation surveys. The RSOwill review radiation surveys in unrestricted and restrictedareas to determine that dose rates and amounts of contamina-tion were at ALARA levels during the previous quarter andwill prepare a summary report for the RSC.

b. Education Responsibilities for the ALARA Program

(1) The RS0 will schedule briefings and educational sessions toinform workers of ALARA program efforts.

(2) The RS0 will ensure that authorized users, workers, andancillary personnel who may be exposed to radiation will beinstructed in the ALARA philosophy and informed thatmanagement, the RSC, and the RSO are committed to implementingthe ALARA concept.

c. Cooperative Efforts for Development of ALARA Pr ocedures

Radiation workers will be given opportunities to )articipate in

formulating the procedures that they will ae required tofollowed.

(1) The RS0 will be in close contact with all users and workers inorder to develop ALARA procedures for working with radioactivematerials.

(2) The RS0 will establish procedures for receiving and evaluatingthe suggestions of individual workers for improving healthphysics practices and will encourage the use of thoseprocedures,

d. Reviewing Instances of Deviation from Good ALARA Practices

The RSO will investigate all known instances of deviation fromgood ALARA practices and, if possibl e, will determine thecauses. When the cause is known, the RS0 will implement changesin the program to maintain doses ALARA.

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1Item 10.2 Page 4 of 5

4. Authorized Users

a. New Methods of Use involving Potential Radiation Doses

(1) The authorized user will consult -with the RSO and/or RSCduring the planning stage before using radioactive materialsfor new uses.

(2) The authorized user will review each planned -use ofradioactive materials to ensure that doses will be kept ALARA.

b. Authorized User's Responsibility to Supervised Individuals <

(1) The authorized user will explain the ALARA concept and -the ,

need - to maintain exposures- ALARA to all supervisedindividuals.

(2) The authorized - user will ensure that supervised individualswho are subject to occupational radiation exposure are trained ,

and educated in good health physics practices and in maintain-ing exposures ALARA.

5. Individuals Who Receive Occuoational Radiation Doses

a. Workers willbe instructed in the ALARA concept and itsrelationship to work procedures and work conditions.

b. Workers will be instructed in recourses available if they feelthat ALARA in not being promoted on the job.

L 6. Establishment o# -Investiaational levels in Order to Monitor IndividualOccupational External Radiat' on Doses

t

This facility hereby establishes investigational . levels foroccupational external radiation doses which, when-- exceeded willinitiate- review or- investigation by the .RSC and/or -RSO. Theinvestigational levels that we have adopted are listed in Table 1.,

L These levels apply to the' exposure of individual workers.

The.RSO willreview and record on form NRC-5, " Current OccupationalExternal Radiation Exposures," or an equivalent form (e.g., dosimeterprocessor's report) results of personnel monitoring not less than once

i in an calendar quarter as required b 20.401 of 16 CFR Part 20. .TheL follo ing actions will be taken at th investigational levels as stated! in Table 1:

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a. Personnel dose less than Investigational Level I.oL Except.when deemed appropriate by the RS0, no futher action will bej taken in those cases where an individual's dose is less than Table -

1 values. for the Investigational Level I.o

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'.Item 10.2 Page 5 of 5

b. Personnel dose equal to or greater than Investigational level Ibut less than Investigational Level II.

The RSO will review the dose of each individual whose quarterlydose equals or exceeds II.vestigational level I and will report theresults of the reviews at the first RSC meeting following thequarter when the dose was recorded. If the dose does not equal orexceed Investigational Leal 'I, no action related specifically to

ess deemed appropriate by thethe exposure is requirCommittee. The Committ :owever, revin each such dose in

erforming similiar tasks as ancomperison with thos. to .

index of ALARA program quo will record the review in theyCommittee minutes,

c. Personnel dose equal to or gt 9ater than Investigational Level II.

The RS0 will investigate in . timely manner the causes of allpersonnel doses equaling or ext.neding -Investigational Level 11and, if warranted, will take action. A report of theinvestigation, any actions taken and a copy of the individual'sNRC Form-5 or its equivalent will be presented to the RSC at itsfirst meeting following completion of the investigation. The

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details of these reports will be included in the RSC minutes,

d. Reestablishment of investigational Levels to levels above thoselisted in Table 1.

In cases where a worker or group of workers' doses need to exceedan investigational level, a new, higher investigational level maybe established for that individual or group on the basis that itis consistent with good ALARA practices. Justification for newinvestigational levels will be documented. The RSC will reviewthe justification for and must approve or disapprove allrevisions of investigational levels

7. Sianature of Certifyina Official

I hereby . certify that this institution has implemented the ALARAProgram set'forth above.

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Cardiology Associates of Birmingham, P.C.. .


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PROCEDURE EOR LEAK-1ESTING SEALED SOURCES

Item 10.3

We will establish and implement the model procedure for leak-testing sealedsources that was published in Appendix H to Regulatory Guide 10.8, Revision2.

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Cardiology Atsociates of Birmingham, P.C..s

NRC tice.ise Rauet.tJuly 19s0.

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Page 1 of 2I

rules FOR lHE SAFE USE Of RADIOPilAletAClullCALSItem 10.4

1.Wear labcratory coats or other protective clothing at all times inareas where radioactive materials cre used.

2. Wear disposable gloves at alltimes while handling radioactive |materials.

3. Either after teach procedure or beforeleaving the area, monitor yourhands and clothing for contamination in a low background area

4. Use syringe shields for routine.

preparation of patient dosages andadministration to patients, except in those circumstances in whichtheir use is contraindicated. In thesethe use of other protective methods such exceptional cases, considerdose. as remote delivery of the5. Do not eat, drink, smoke, or apply cosmetics in any area whereradioactive material is used or stored.6. Do not store food, drink, or personal effects in areas whereradioactive material is used or stored.7. Wear personnel

times while in areasmonitoring devices (asStore personnel monitoringwhere radioactive materials areprescribed by the RS0)at all

used or stored.low-background area. devices at the facility in a dodgaai.ed8.

Wear a finger exposure monitor during the elution of generators;during the preradiopharmaceuticals; paration, assay, and injection ofand when holding patients during procedures.

9.Dispose of radioactive waste only in designated, labeled, and properlyshielded receptacles.

10. Never ploette by mouth,11.

Wipe-test byproduct material storage, preparation, and admir.jstrationareas weekly for contamination,the area for contamination. if necessary, decontaminate or secure,

12.

With a radiation detection survey meter, survey the generator storagekit preparation,and injection areas daily for contamination.

Ifnecessary, decontaminate or secure the area for decay as appropriate,

13.

Confine radioactive solutions in shielded containers that.

labeled with the isotope, compound name,and the date and time of

are clearlyreceipt or preparation.

Syringes and/or syringe shields shall belabeled with the radiopharmaceuticalwithin, type of study, or patient's name. or abbreviation containedname

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'c14. Assay each patient dose in the dose calibrator before admin-

istration. Do not use a dose if it differs from the prescribed doseby more than ten percent, except prescriptions of less than 10 uCi.Check the patient's name and I.D. number and the prescribedradionuclide, chemical form, and dosage before administering.

15. Always keep radioactive materials in shielded locations orcontainers.

16. When practical, use a cart or wheelchair to move flood sources,syringes, waste, and other radioactive material.

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Cardiology Associates of Birmingham, P.C. 1..


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EMERGENCY PROCEDURES-

Item 10.5

Minor Spills

1. NOTIFY: Notify persons nearby that a spill has occurred.

2. PREVENT THE SPREAD: Cover the spill with absorbent paper.

3. CLEAN UP: Use disposable gloves and remote handling tools.Carefully fold the absorbent paper with the clean side out and insertin a plastic bag for tr ansfer to a radioactive waste container. Alsoplace the contaminated gloves and any other contaminated disposablematerial in the bag.

4. SURVEY: Survey the area with a low-range, GM survey meter. Check thearea around the spill, hands, clothing, and shoes for contamination.

5. REPORT: Report the incident to the RS0 who will supervise the cleanupof the spill and complete the Radioactive Spill Report and theRadioactive Spill Contamination Survey. The RSO may delegate theactual clean-up and survey performance to a trained technologist.However, the RS0 will retain the ultimate responsibility to ensurethat the Report and Survey are completed properly.

tLa.ior Spills

1, CLEAR THE AREA: Noti fy all persons not involved in the spill tovacate the room.

2. PREVENT THE SPREAD: Cover the spill with absorbent paper but do notattempt to clean -i t up. Confine tile movement of allpersonnelpotentially contaminated to prevent the spread,

3. SHIELD THE SOURCE: This should be done only if it can be done withoutfurther contamination or a significant increase in radiation exposure.

4. CLOSE THE ROOM: Leave the room and lock the door (s) to prevent entry.

5. NOTIFY: Notify the RSO immediately.

6. PERSONNEL DECONTAMINATION: Decontaminate personnel by removingcontaminated clothing and flushing the contaminated skin with lukewarmwater and then washing with mild soap. If contamination remains,induce perspiration by covering the area with plastic. Then wash theaffected area again to remove any contamination released by theperspiration.

7. REPORT: The RSO will supervise the cleanup of the spill andcomplete the Radioactive Spill Report and the Radioactive SpillContamination Survey. The RSO may delegate the actual clean-up andsurvey performance to a trained technologist. However, the RSO willretain the ultimate responsibility to see that the Report and Surveyare completed properly.

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Cardiology Associates of Birmingham, P.C...NRC License RequestJuly 1990

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PACKAGE ORDER AND RECEIPT PROCfDURLS

Item 10.6

1. The Radiation Safety Officer (RS0) or a designee must authorize eachorder for radioactive materials and ensure that the requestedmaterials and quantities are authorized by the license for use by therequesting authorized user and that possession limits are notexceeded.

2. The RSO will establish and maintain a system for ordering andreceiving radioactive material. The system must contain the followinginformation:

a. for routinely used materials

(1) Written records that identify the authorized user ordepartment, isotope, chemical form, activity, supplierwill be made.

(2) The above records will be checked to confirm that materialreceived was ordered through proper channels,

b. For occasionally used materials 'e.a.. thenpatic dosigg11

(1) The authorized user who will perform the procedure willmake a written request that indicates the isotope,

radiopharmaceutical, activity, and supplier.

The person who receives the material will check the(2) physician's written request to confirm that the materialreceived is what was ordered.

3. For deliveries during normal working hours, packages are received atthe Niclear Medicine department.

4. If off-hour deliveries are necessary, the delivery personnel will beprovided with a key to the building and to the Nuclear MedicineDe3artment. They will be instructed to 3roceed directly to the HotLaa leave the packato inside. They will ae asked to re-lock the doorwhen they exit. Enclosed is a sample memorandum which will beprovided to the delivery company.

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MEMORANDUM

To: Radioact sve Material Delivery Personnel

from: Cardiology Associates of Birmingham, P.C.

Re: Off-hour deliveries

You have been provided with a key to our building and suite. Youare to proceed directly to the Hot Lab area and deposit thepackage at the location noted by the " Radioactive MaterialPackages Here" sign. You must re-lock all doors when you exit.

If for some reason you are unable to oF'ain entry to our suiteand the Hot Lab you are not to attempt 1, leave the package.

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Cardiology Associates of Birmingham, P.C.,,

NRC License RequestI July 1990

,! s

PROCEDURE FOR OPENING PACKAGES CONIAINING RADIDACTIVE MAIERifL

item 10.7

1. Put on gloves to prevent hand contamination.

2. Visually inspect the package for any sign of damage (e.g., wet orcrushed). If damage is noted, stop and notify the R$0.

3. Measure the exposure rate from the package at 1 meter and at thepackage surface. If the rate is higher than expected, stop and notifythe RSO. The surface dose rate should not exceed 200 millirem perhour. Packages with the " White 1" labels should be less than 0.5millirem per hour at the package surface.

4. Follow the steps listed below when opening the package.

a. Remove the packing slip,b. Open the outer package following the supplier's instructions, if

available,

c. Open the inner package and verify that the contents agree with thepacking slip.

d. Check the integrity of the final source container. Look forbroken seals or vials, loss of liquid, condensation, ordiscoloration of the packing material.

e. If anything unusual is noticed, stop and notify the RSO.

5. If there is any reason to suspect contamination, wipe the externalsurface of the final source container and remove the wipe sample to alow background area. Assay the wipe with a thin end window GM meteror a well counter to determine if there is any removable activity. If

there is any contamination, notify the RSO.

6. Verify that the material received is the material ordered.

7. Monitor the packing material and the empty packages for contaminationwith a GM survey meter before discarding. If contaminated, treat asradioactive waste. If not contaminated, deface all radiation labelsbefore discarding.

8. Record the receipt and all readings taken.

9. For packages received under a general license in 31.11, follow thesteps listed below for each package,

a. Visually inspect the package for damage, if damage is noted, stopand notify the RSO,

b. Verify that material received is the Material ordered.

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'(Cardiology Associates of Birmingham, P.C.,,


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oBYPRODUCT MATERIAL USE

Item 10.8Unit Dose Records shall contain:

1. Technical Data

a. Radionuclideb. Chemical form or abbreviationc. Date of receiptd. Activity as recorded on the packing slipe. Supplierf. Lot or control number

2. Administrative Data

a. Time and date of administrationb. Measured activityc. Patient name and ID numberd. Method of disposale. Initials of person recording the information

item 10.9Multidose Vial Records shall contain:

1. Technical Data

a. Radionuclideb. Chemical form or abbreviationc. Date of preparationd. Date time, and activity of initial assay

Supplierofkitmanufacturere.

2. Administrative Data-

a. -Date and time dosage was drawnb. Precribed dosagec. Calculated inverse concentration (cc/ mci) at drawing timed. Calculated volume needed for prescribed dosee. Measured activityf. Patient name and ID numberg. Method of disposal and dateh. Initials of person recording information

Item 10.10Molybdenum Concentration Records shall contain:

1. a. Date the generator was receivedb. Date and time of elutionc. Measured Mo-99 activity in microcuriesd. Product of the measured Mo-99 activity and the correction factor

noted by the molybdenum breakthrough pig manufacturer-

e. Measured Tc-99m activity in millicuriesf. Ratio of the total Mo-99 microcuries per millicurie of Tc-99m

and documentation that the ratio is less than specified in10 CFR 35.204 (a)

9 Initials of the person who made the record

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Cardiology Associates of Birmingham, P.C.,,

NRC License RequestJuly 1990,

-0- page 1 of 2AREA SURVEY PROCEDURES

Item 10.12

Surveys for contamination and ambient exposure rates will be performed inaccordance with 10 CFR 35.70.

1. All areas where radiopharmaceuticals are eluted, prepared, andadministered will be surveyed at the end of each day of use forambient radiation exposure rates and weekly for removablecontamination. Special care will be taken to remove all paraphernaliafrom patients rooms where diagnostic administrations are occasionallymade; and these rooms will not be surveyed.

2. All areas where radioactive materials are stored will be surveyedweekly for ambient radiation exposure rates and for removablecontamination.

3. Laboratory areas where each process involves less than 200 uCi ofbyproduct materials will be survey monthly for ambient radiationexposure rates and removable contamination.

4. Surveys for ambient exposure rates will be performed with a radiationdetection-survey instrument able to detect as low as 0.1 mR/h.

5. Surveys for removable contamination will consist of a series of wipeswhich will be assayed using a procedure sufficiently sensitive todetect 2000 dpm.

6. The trigger level for exposure rate surveys will be rates twice thenormal background reading for that area.

7. The trigger level for removable contamination surveys will be thedetection of values equal to or less than the recommended levels inTable N 1 of the Regulatory Guide .10.8. For example, the action levelfor Tc-99m contamination will be 2000 dpm or lower.

8. Survey results greater than the trigger levels will result indecontamination or shielding procedures necessary to reduce theexposure or contamination levels to background on repeat surveys.

9. A record shall be kept of all survey results. The record willinclude:

a. Location, date, and type of equipment used.b. Initials of the person conducting the survey,c. Drawing of the area surveyed.d. Trigger levels keyed to the location on the drawing.e. Results keyed to the location on the drawing.f. Corrective actions taken in case of contamination or excessive

exposure rates and reduced contamination levels after correctiveaction.

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.O 10. The RSO will be notified when the trigger levels for surveys and wipe

tests are exceeded or if unusual readings are observed. Therefore,the RSO will review the survey results on a quarterly basis ratherthan a monthly basis as requested in the Regulatory Guide,

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Cardiology Associates of Birmingham, P.C.Cp NRC License RequestJuly 1990.

oWASTE DISPOSAL

Item 11.1 Page 1 of 2

J,iauids and Gases

Liquids may be disposed of by release to the sanitary sewer or evaporativerelease to the atmosphere.

1. Disposal to the sanitary sewer system will be made in accordance with10 CFR 20.303. A record will be kept of the followino: dateradionuclide, estimated activity released, and place where inaterialwas released.

2. Permissible concentrations in effluents will be kept within the limitsenumerated in Table 11 of Appendix B of 10 CFR 20. A record will bekept of the date, radionuclide, estimated activity released, estimatedconcentration, and vent site at which the material was released.

Decay in Storace

1. Only material with a physical half-life of le;s than 65 days may bedecayed in storage at the facility.

2. Each container will be tagged to include:a. the date sealed or set into storageb. the longest-lived istope in the containerc. the initials of the person setting the waste for decay.

3. Material will be decayed for at least 10 half-lives.

4. Prior to disposal as in-house waste, each container will be monitoredas follows:

a. Low-range GM survey meter will be checked for proper operation. Jb. Waste will be monitored in a low level area. >

-c. Any shielding around the container will be removed.d. All surfaces of each individual container will be monitored.c. Only those containers which cannot be distinguished from backgroud

levels will be disposed of after all radioactive labels have beendefaced,

f. The date on which the container was placed in storage will berecorded,

g. The date of disposal will be recorded.h. The type of material will be recorded.

5. Mo-99/Tc-99m generators will be held for at least 60 days before beingdismantled. When dismantling generators, a low-range GM survey meter '

will be kept at the work area. The oldest generator will bedismantled first, working forward chronologically. Each individualcolumn will be held in contact with a low-level survey instrument in a

low background (less than 0.05 mR/h) he disposalThe generator date andarea.

disposal date will be logged in t records. Radiationlabels will be removed or defaced on the generator shield. Generatorsmay also be returned to the manufacturer for disposal.

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Unit Dose Waste;

if a unit dose pharmacy is used, the materials supplied by them (e.g.,syringes, needles, etc.) may be returned to the unit dose pharmacy in theoriginal shipping container. Pertinent 001 regulations will be followed asspecified by the unit dose pharmacy.

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