Us. NU- REGULATORY C o y Y ~ APPROVED BY OM& NO. 3150420 EXPIRES: 101311200 Estimated burden per respm?se to m p l y with this mandalwymllectim request hours. Submittal of the application is necessary to determlne that the applicant i qualified and that adequate proceduya exist to pmtect the public health and safet) sendcomments tdiilghrrden t o l h e ~ ~ a n d F O W r i w a c y ~

or by internet e-mail to infocollects nrc ov, and to the Desk Officer, Office c Information and Regulatwy Affairs. N88-d202, (3150-0120), O f f i i of b@qjemF and +jget, Wesbngton, DC 20503. If a meens used to impose an mfomatm collectcon doesnotdispleyaarrrentfy val id~cont fo lMmt(wr , the F C may? conduct or sponsor, and a person is not required to respond to. the informatioi collection.

NRC FORM 313 (4-m) 10 CFR 30.32,33. 34,s. 38.39.and40

Brandr p-5 rnh% t d u c b r e w WaSkX$M,Dc205560001

APPLICATION FOR MATERIAL LICENSE

DMSlONOFINWSTRWANDMUHCALNUCWRSAFFlY OFFiCEOFNucLEARMATERLALSsAFETyANDsAFH;uARDs U.S. NUCLEW. FEGUIATORY COMMlSSlON WASHINQTON, DC 205550001

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS: I ,

ILLfNOtS. INOIMA, IOWA, WCtWAN, MINNESOTA, uW(p0URl OHK), ORyIIIscowSlN. SEI0 AppuGdfKmsTo:

MATERlALS LICENSING BRANCH U.S. NUCLEAR REGULATORY COMMISSION. REGJON HI 2443WARRENWtEROAO.~2M LISLE, IL 605324352

R 7 W A R E L O c A M ~

AUBAUA, CONNECTICUT. DELAWARE, MSTRICT OF eoLuwm FLORIDA. GEORGIA, W K Y , MINE Ywnurro. MASSACHUSETTS, yI(ssIssIppI, NEW WpsH(RE,

OR WEsTVIRoRllA sE)(DAP~noHsTo:

LICENSING AsslsTANcE TEAM DMSlON OF NUCLEAR MATERWS SAFElY US. NUCLEAR REGULATORY COUUISSION, P E W N I 475 ALLENDALE RaAD KING OF PRUSStn. PA 1-1415

u s w A R ~ ~ D N A , ARKANSAS CALIFORNIA, COLORADO, HAWAII, IDAHO, KANSAS,

o~eoon. PA- mm TERRKVRES, sown mcom TEXAS, unn, wmmmm. LOWSlMA, MONTANA, NEBRASKA. NEVADA. NEW -0. NORE4 DAKOTA, OKuHOyA

OR WYOMING, SEND APPLICATIONS T O

NUCCEAR MATERLALSUCENSINGBRANCH US. NUCLEAR REGULATORY COMMISSION, REGION N 611 RYAN PLAZA DwM Sum 400 ARcMGToN,Tx rnli-mo5

1

1. THIS IS AN APPLICATION FOR (check appmpate item)

A NEWUCENSE

0 8. AMENDMENT TO UCENSE NUMBER

. C. R ~ A L O F U G E N S E M M B E R 29-04333-01 3. ADORES WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED

Same

I (908)994-5226

2. NAME AND WUNG ADDRESS OF APPLICANT (/dude UP CMlS)

Trinitas Hospital Witiiamson Street Campus 225 Williamson Street Elizabeth, New Jersey 07207

4. NAME OF PERSON TO BE CONTACTED ABOUTTHIS APPucATloN

Nancy DiLiegro, PhD

s. w t x o A c n v E w w i w ~ a. eamsntand nass manbn; 4.chamicaiandtorpfom andr mebmnnn anmunl

w h i i will be OOSSBSSBd at anv me h e .

12 LICENSEFEES ( S ~ l O ~ ? 7 O a n d ~ I 7 0 . 3 1 ) AMOUNT 11. WASTEMANAGMENT.

13. CERTTFICAlWN FEECATEGORY IENcLOsm $

usf ha compreled byapprmnl) THE APPLlCRNT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THlSAPPLICATlON ARE BINDING u w N w AwL1CAt.P

6. PUfPOYqs) FOR W n C- MM~?~ALWK*BE u?eci

THE APPLfCANT AN0 ANY OFFK3AL EXECHW lUlS CERMfCATiON ON BEHACF OF THE A?PWANT NAMED iN ffEM 2 CERTm MAT TMS A?PLfCATlON 15 ?R€?AREO ttJ CONFORMITY WlM TITLE 10. COM OF FEDERAL REGULATIONS. PARTS 90.32.33,34.35.36.39, AND h, AN0 THAT ALLiNFoRMATlON CONTANEO HEREIN IS TRUE AND I CORRECT TO M E BEST OF THEIR KNOWLEOGE AND BELIEF.

I AppRoMDBy DATE

I NRC FORM 313 (4-2004) PRINTED ON RECYCED PAPH

t

Item 5

Byproduct, source, and/or special nuclear material

Chemical and/or physical form Maximum amount that that licensee may uossess at any one time under this license

A. Any byproduct material A. Any Permittedby 10 CFR35.100

B. Any byproduct material B. Any permitted by 10 CFR 35.200

C. Any byproduct material c. Any permitted by 10 CFR 35.300

A. As needed

B. As needed

C. 500 millicuries

D. Any byproduct material D. Sealed Source (3M Models 6510,6511,6512and6513; Isotope Products Laboratories Models 67-802,67-803 and

D. 1000 millicuries

67-804)

E. Any byproduct material

F. Depleted Uranium

G. Iridium 192 as permitted by 10 CFR 35.600

H. Iodine 125

Item 6

E. Sealed Source (North American Scientific Model h4ED 3601 or Isotope Products Laboratories Model A34 10)

E. 300 millicuries per source and 24 curies total

F. Metal

G. Sealed Source (Model 096.001 manufactured by both Mallinckrodt Medical B.V. and AEA Technology)

H. Liquid lotrex as part of the Gliasite RTS System

F. 55 kilograms

G. 12 curies per source and 22 curies total

H. 8 curies

- / 'CI &j -q 3

0 Authorized use:

A. B. C. D.

E.

F. G.

Any uptake, dilution, or excretion study permitted by 10 CFR 35.100. Any imaging and localization study permitted by 10 CFR 35.200. Any therapy procedure permitted by 10 CFR 35.300. Any manual brachytherapy procedure permitted by 10 CFR 35.400; Cesium 137 sources in 35.400 for calibration of licensee's survey instruments. For use in an ADAC Model Vantage gamma camera for patient attenuation correction during S.P.E.C.T. imaging. For use as shielding in an ADAC Model MCD-AC gamma camera. One source for medical use described in 10 CFR 35.600 in a Nucletron Corporation MicroSelectron HDR Classic remote afterloader unit. One source in its shipping container as necessary for replacement of the source in the remote afterloader unit. For manual brachytherapy use in the Proxima Therapeutics' GliaSite Radiotherapy System. H.

The following individuals are authorized users for medical use as indicated:

Authorized Users

Eli Finkelstein, M.D.

Material and Use

35.300; 35.400; Iridium 192 for uses in a High Dose Rate Remote Afterloader Unit; Iodine 125 for use in the GliaSite RTS System

Jeffrey Stirling, M.D. 35.100; 35.200

Edward S. Rittweger, M.D. 35.100; 35.200; 35.300; 35.400; 35.500; Depleted Uranium

Charles Saniewski, M.D. 35.100; 35.200; Oral administration of sodium iodide, Iodine- 13 1 for imaging and localization studies and treatment of Hyperthyroidism and cardiac dysfunction

Carl J. Vitale, M.D. 35.200

Jeffrey M. Gold, D.O. 35.200

Ralph Eastman, M.D. 35.300; 35.400; Iridium 192 for uses in a High Dose Rate Remote Afterloader Unit; Depleted Uranium

All the above authorized users are currently on this license

I The following individual is an authorized medical physicist as indicated:

Authorized Medical Physicist

Trent Hall

Linda Veldkamp

Gary L. Jones

Material and Use

Iridium 192 in a High Dose Rate Remote Afterloader Unit For calibrations, spot checks, and training

Iridium 192 in a High Dose Rate Remote Afterloader Unit for calibrations, spot checks, and training

Iridium 192 in a High Dose Rate Remote Afterloader Unit For calibrations, spot checks and training

Linda Veldkamp is the Radiation Safety Officer for this license.

The above authorized medical physicists are currently on this license.

Attachment 9 A Facilities and Equipment

Hot Lab:

The hot iab is the location where radiopharmaceuticals are stored, prepared and dispensed. Lead bricks or lead lined storage moduIes are used to provide shielding where necessary. The hot lab has an .‘L” block present. Additional lead shielding is used around the “L” block where necessary. Absorbent, plastic backed paper is used to line the counter tops where radioactive material is used.

DOT shipping containers for the transport of These will be used for storage of patient doses until their use unless a suitable alternative exists.

unit doses provide significant shielding.

# Storage of Radioactive Material and Waste:

Lead lined (118 inch ) disposal cans are present in the hot lab areas for the storage of

active waste. Lead lined (1/8 inch), or equivalent, storage modules are present for the storage of radioactive material.

radio-

Additional Safety Equipment:

The following safety equipment is also present for use at the licensee’s facility and at locations where radiopharmaceuticals are used.

syringe shields syringe carriers disposable protective gloves absorbent pads remote handling devices lead shields for vial storage lead lined storage modules

lead equivalent L-block lead bricks (as needed) lab coats

TRINITAS HOSPITAL El izabe~ NJ NRC License # 29 - 04333 - 01

Radioactive Materids Use Locations:

Nuclear cardiology { 1 ’* Floor)

Nuclear Cardiology Imaging Room # 1 Nuclear Cardiology Imaging Room # 2 Nuclear Cardiology Stress Room #1 Nuclear Cardiology Stress Room #2 Nuclear Medicine Hot Lab

Item 9B Item 9C Item 9D Item 9E Item 9F

Nuclear Medicine Basement)

Nuclear Medicine Imaging Room Xuclear Medicine Hot Lab I’ Probe Room

Item 9G Item 9H

Bracytherapy Hot Lab ( Basement) Item 91 h- Patient Bracytherapy Treatment In- Patient I 13 1 Treatment 2 Item9J

TRINITAS HOSPITAL Elizabeth, N3 NRC License # 29 - 04333 - 01

r

2. Skk 4. Waste Bin 2 . i iesk '7.h4oaitors 8.Floor ?.Canera 1O.Floor

6. Soiled Laundry' " n

TRTNITAS HOSPITAL Elizabeth, NJ NRC L i ~ e n ~ e # 29 - 04333 - 01

1 .Table 2. Control ConsoIe

3. Sid< 4. Waste Bin 5 .Desk 6. Soiled ‘Lamdry 7.Pdonitors 8.Floor 9.Camera 1O.Floor

TRINITAS HOSPITAL Elizabeth, N3 NRC License ## 29 - 04333 - 01

1) Tread Mil! Head 2. Tread Mil1 Belt 4.sink 6. Waste Bin 8,Floor

>, t x: c her 3) 5) EKG

TRINITAS HOSPITAL Eiizabeth, NJ NRC L i e n s # 29 - 04333 - 01

1 .'Tread Mill Head 3. Stretcher 4.Sink 5. EKG. 6,Waste Bin 7. Floor 8 .Floor

2. Tread Mill Belt

TRINITAS HOSPITAL Elizabeth, NJ NRC License ## 29 - 04333 - 01

P

1 .Dose Calibrator 2. L-BIock 3. Desk 4.Sink 5. Storage Area 6.Waste Bin 7. Needle Box 8.Floor

TRINITAS HOSPITAL EEzdxth, N3 NRC License # 29 - 04333 - 01

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

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Imaging Table CameraHead

work Area C~era/compUtercontroi

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Injection Cart Work Area Key Board Dose Calibrator L Block

6. Radioactive Sharps / Non Sharp Waste Storage ( Lead Lined) -

7, Waste Storage 8. Floor 9. Waste

10. Thyroid Probe / Well Counter 11, Work&

? S TRINITAS HOSPITAL Elizabeth, NJ NRCLicen~e#29-04333-01

Bracq.therapy Hot Lab ( Basement )

-i , . -_

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

.-

1

2

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4

Cs 137 Lead Safe L -Block W Lead Brick Cave Pd 103 / I 125 Seed Prepamtion

Hood/ WorkArea

Storage Cabinet

TRINlTAS HOSPITAL Elizabeth, NJ NRC Licen~e ## 29 - 04333 - 01

Bmqtherapy./ I 131 In-patient Treatment Room

9& Floor South Building - Room 9206

. . . . . . . . . . - . -

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- - - .... ........ .- . . . . . . . . -- .... . . .- ........... . . .

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I Bed 2 Chair 3 Bathroom 4 Sittingarea

..-.--.-

Page 1 of 1

i ,L,,,-..,,. M*.,-....--"a ,,,- ~ Y I - ~ c u L u u . u " * " -I---. ..IUUI~.-l----.--.-r-..LhU(t.-lrUU1.~.~"~-~-,~~

f POLICY: The handling of radioactive material used for OR procedures mst-lre imndkd according to the i ; f PURPOSE: To ensure the proper procedure i s known by all staff involved in the handling of radioactive f

i SCOPE: Interdepartmental ! ' "ROCEDURE:

established guidelines to ensure safety of the material, the staff, patients, and the general public. 1;

material used in this manner. k /I

Radioactive seeds shall be kept under the control of radiation safety persorxnef atail times -&her locked in a safe storage area that is marked "Caution Radioactive Materials" or in the possession or direct observation of the dosimetrist, or physicist. Personnel working directly with the seeds will be issued radiation monitors and will be in-serviced in radiation safety practices and regulations at least annually. The seeds will .betranspoxted in the lead-lined envelope they are shipped in to Trinitas. Large labels shuuld be placed on both front and back of the envelope identifying the contents as Tadioactive. 'The infennatbmequired en the yetlow cautian radioactiveaakrial label m a t be compteted. The individuai trwsyorting-tfn setdststhtoR . should use a aif? that has the rop sided to prewml the package o f seeds from sjiding off. When being transported, the seeds will be kept in sight at all times. The shortest route possible to the operating room will be chosen that will also minimize public contact. The seeds wilt be transported directly to the operating room where the procedure will take place. The seeds will be kept in sight of the dosimetrist or physicist until used or presented for transport back to the safe storage area. If multiple prucedures ate scheduled, the packages of seeds must be transpoxted separately for each procedure.

' ., ..: _. .

Trinitas Hospital RADIATION ONCOLOGY POLICY AND PROCKDURB

SUBJECI'r ULTRASOUND GUIDED IMPLANTATfON OF THE PROSTATB UTILIZING 1-125 OR Pd-103

DATE : DECEMBER 12, 1995

INTRODUCI'IO : r The use of transrectal ultrasound visualizing . the pr&ate

now gives us the ability tu define the gland and visualize the relation of the needles and the seeds to the gland using real-time imaging. The use of the transperheal technique and the ability to- observe the gland, needles and seeds in a dynamic fashion w i l l ensure accurate seed placement.

PATI-* S E I i i ~ ' C K X T E R I A : \d

P a t i e a s with histo logica l ly proven prostacic cancer in clinical stage8 AII, B, or early C w i t h an anticipated general life expectancy of more 5 yeaxs are the principal candidates .far this treatment. Genera l ly , patients w i t h disease O U t 6 i . d e the

. prostate 0ch.e~ than eax3.y capsular i n V 3 S i M are excluded f r a m - t h i s type of treatment. Because of the l o w photon energy of Iodine 125 or- Palladium AU3 implanting large mxqlasms or large 9 - n (greacer than 75 grams) are contraindicated.

TECHNIQUlf :

Images af the prostate are obtained using a biplanar ultrasound probe placed in the r e c t u m . A rigfa template is attache& to the probe to be uaed as a guide Eor the .implant needles . A volume measurement of the prcstate i s obtained u t i l i z i n g a stepping device and summing the volume over multiple sections. T h i s volume measurement is used to determine the t o t a l activity needed for the implant- and 16 preplan t h e fiaal Jccatictn-of a e i . .mpla~t seeds- A typical 6-e i s 160 Gy-for Iodine l 2 5 - a d 115 Gy far P a l l a d i u m 1 0 3 L Needles are inserted through the guide holes in the template i n t o the prostate gland utilizing ultrasound for plat-nc. The correct position af the needles is veri€i.ed in the txansvemse and longitudinal planes. The Mick-applicator gun is attached to the needles once their obturator is removed and the appr~priatr? number of seeds are dropped in the pre-planned designated areas.

\+,J

P o L I C Y R q m ,

RADIATION SAFETY:

A t L& c o m p l e t i a n of the procedure the patient’s catheter is opened to drain the ur ine which must be inspected for seeds w i t h a sumey instrument. A seed count mu6t be performed to verify that the number of seeds implantedplua the number of seeas remaining is .equal to the ariginal number af aeeds. The patient should be kept in an isolated mom, The room should be properly posted w i t 4

urine must be strained for aeede and the l inen must be checked w i t h a survey instrument before removal from the patient’s room.

Seeds which were implanted and passed must be stored for decay.

necessary s i g ~ , pat&-ent -care a a d uisixor instruc ticma. P&Ltieat

Unused seeds m y be returned to the manufacturer for disposal .

APPROVED :

Medical Director Date

/a/ J ) / Q c at iveVDirector Date’

, ’. ,

I---.- ... .. .

Pre- araadrue.

I ) seeds shall be kept under control of radiarton safety personnel at all tlmes - either

locked m a safe storage area whch is marked w t b a ‘Cautlon U o a c u v e Materials”

sign or in the possession on the radiatron safcty persontiel,

2) persMncl uwkrirg directly with the seeds will be ~ssued reniatlon monitors and Will

be in-serviced 111 rahatioii safety practices and regulations at least annually,

purim~ Dropcdurcz

3) all pcrsonrrel in the QBsurre \Hll1 bemmmredfbr f d a t m n x m e ,

4) mpregnanlstafl‘willwarkmtbeORforrbesecases,

5 ) all sccdstalcen into the foocl~ wrll-be accounted for before anyom leaves the r o a m

and if staff must leave before aU seeds are accounted for they wiJJ be mmitored wth

a sensitive Watron detector, u d h ( m t c l a l ~ ~ ~ & ~ ~ ’ mlhcsofrsofk-shoes,&r

totheir exit from thc op e

6 ) i f a seed is lost or broken, the room Will hc.ItlltEdllWA and ccmtahall mdhactive ma!cnaJs.

m e Y * f a e s

7) the panat Wili be carcfulty surveyedprior to release from the OR to the PACU to

ensure that thwe are no seeds e tohis b o d y , + ~ ~ I atledan N b e W d to

the any urine andseeds wiU bt r c m m s & u m ; ( ~ h ~ ~ r S before duposal of the u r y ,

Post Drocdurc:

8) the patient wll be rer;ov~edjnap bulatcdm- of PACU it5 m, 9) the patient wiU be kept at Jcast 6 fkt from any pregnant w ~ m e n and children under

the age of 18,

IO) thepauent’s mne Jarillkm~~~m&-hq+&~whj& ~ta).btAk&a@ mdttre S e d s w i J J b C c ~ ~ ~ EnntaiRrr

1 I ) prior to dscharge, the patient \Hill have a measurement made of the dose raws

e m W a t the surface and at I meter h m the impht

. .

12) the parim ~~drscbargedhy d k s c n l h m e wtha set Q f r a d m d l y

a) keep at least 6 ft away fiom pregnant women and chldren for the first month

precautions rncluding.

after a P&&um 103 rmplaot and for three months &er an lodrnc 125

implant, ,

b) strain any unae Tor the first week aiier the implant and remove any seeds

whichare~mthatwtYcrsDrrprmnaPdalertPU~113e~-L’Oataiaer

provided or in ajar whtch contains about 3 inches of water. Return these

seeds io the Radiation Oncology Deparmrent a! earliest convenience,

c) use a condom during sexual intercourse for the first two weeks,

d) ditisnecessiuy r o g o m a n ~ ~ y r i m m ~ ~ ~ v r a n y s l e d i f a l

Hospital at your

procedures which involve a urinary catheter during the first 6 months after a

Palladium 103 implant or -the fust 20 months following an I&e 4 5

impiant, make sure to felt them about your seed implant and have them call themrllntlrur

have any radiation safety concexy. uf.ctvo= **Y

. .

18) all bedding and otber matcrrals . 6om the room wrll be placed in a radiauon waste b q

until they are monitored and released by the radiation safety office,

19) the p a t h wdl-not be discharge&uRtiltkx,esponsible physician and the radiation

20) rht room will nat be reiasexi until br; odiarron safety ofice agree that i t is altowable,

smvepi~uz-roorn

with a radtation detectlon meter and determitied that it is free of radiation sources.

Department of(‘ ation uncdlogy Prugtate Sced Jmghant Check-Off List (

Pa(icni Name: Volume Study Dale: Implant OR Dale:

heconsult 1. Dihgnostic Tests Requested 2. kttords,and alms obtained 3. Verification o f insutaance & beriefits

Corrnrl~aiiod i . Prp-pmcduraJ teaching 2. Volume study teaching 4 . Ask id psychosocial status & hbrndliving Sifuatioci for safely 4. Requqst for scheduling of Volume study 5 . Rquest for scheduling of OR time

1 . Cohtacl Medical Ph ics tbr’setd ordering (Ming) 1. Vo(uwe study sche k” u14 j. Vo!urne study department noliflcatiotl 4. Voiurne Study scheduled in conlputer 9. volume huqy p p instmctiops giveti 6. Copy ofvolunie Study Check list to tk sent arouhd deparlmtnl

I. Consent Tor Volume study combleted 2. Prehop instructions given iulhand-outs 3. Medicotibn scheduld and firescriptions givdn 4. Codfirmation of schtduled OR lime or consult appointment Si OR time schedtrled ih cdputer

I , Request tb physicist For sdcd delivery 2, Confinnation of seed d e l i b y

I. Posting okQP time for d-mknt 2. Equipmerlt to OR 3. Radiation Safety

PdSl-O# 1. Disaharge teachink dc insthctiohs given 2. Radiation safe;) ieacfriog 8: instructions giCeii

Iehsc always notify $e f$Iowjng iqdioiduais: ’ Pliysibiqn ” ’

p -

he-vdlurne Study

, VOIU~C Study

1

stcd oidcring

h n t i n g Robm

--1,

. Responsible PetJon

1 k D td sccrcwy 2. Secretary 3. Financial Couiisclor

I . MD 2. Nurse 3 . NursdSocial Worker 4. rJursc 5 . h4D td sccrdtary

I . Secretary 2. Secretary 3. Secretary 4. Secretary 5. Nurse 6. Secretary

1. kTTlWursc 2. kursc 3. Nurse 4. Secretary 5. Secretmy

1. MD 2. Physicist

1 . Secretary 2. Physicist 3. Radiation safely designte

Datt Cob plered

l

. L

. -"

I . f m l r a m n t a( Car0 ($C)

PAGE S of 1

'4

POLICY: AH radiactive seeds disladged from an implanted patient during surgery-shonkt% -mHected and deUvered lo the Radiation Safety Officer.

PURPOSE: T o m r e that noneof the Operating Room personnel or other staff are exposed 19 anywwanted radiation

SCOPE: I nterdepactrnentd

PROCEDURE; if any radioactive seed get6 djslodged during the procedure, do not tom h-with W e hands. Handle it with forceps and place it in a plamc contarne~.

Prefsiahly. pour some water in the container to shield the radiation coming. out of the seed.

Call the Radiatm Safety QBkpr at extension5039. In hu-absence, caftftecrifction O n c o ~ y at extension 5003.

The Mallon Safety Officer will keep the seed lor decay in storage

TO

FROM

: Pat Hamp

: Balan Xodery,M .S . Director,O.R.Semices

Radiation Safety Officer

i.Fir~t,you may note that we hatre not been daiag seed implant8 at thx8 hospital for ovex 13,years.These patients had cheir implants -doni= at wt-fter facilit ia3.

2.The facilitiee da these procedures are required-by regu&atior= to prorri.de these patients with written irrstructions,which include alertiyg rhe physicians and surgeons they cmmtuh I about t k e k implanFe -

3 . When such a p e z n t comes to this f a c i l i t y .and Lhe m - i e n t and the referring physician f a i l e d to n o t i f x t h e surgeon about the imp1ant;tken w e have a problem.

radloactive

RADIATION SAFETY ISSUES:

1.Vnless the surgery is doneon the same gland ox organ,say prostate, the r a W n exposure to the surgeon in insignificant . The otrerlyipg tissues of the patient’s body icself shield the radiation.

2. If surgusy is d ~ n e on the i q h n t f d organ _oT in the vicinity, the finger6 of the surgeon w i l l be expoeed to some minor radiation &se,ht w e l l within the permlB8lble 1imits.The amount Qf radiatian received depends on number of factors such a6 age of the irnplant,.number of seeds and activity used, and the proximity to the implanted area.

3 . I f eesds are disladged during surgery,it shcmld be collected with a foreceps a d stored in a plastic cantainer.Preferably,you may pour s o m e water in the colEtainer,to reduce the radiation dose.The ~~ntainex.should behanded over to Radiation Safecy O f f i c e r or in hie absense,the Radiation Oncology department . The contact numbers are 5039 and SO03 respectively.They w i l l s t o r e it for decay in safe shielded place.

4.The radiation seeds are of l o w a c t i v i t y and handling them w i t h a forcepls would give insignificant &se Lo the person.Therefore,if a dislodged seed was identified and put aside aa described in the previous paragraph,then nobdy got exposed to any significant amount of radiation and there is no Radiation Incident.

cc: Quality Aasqarance Tracey Murpqy

'.

Subject:RECOVERED.mSLODGED RADIOACTIVE SEEDS IN OPERATSNG ROW. Formulated: Reviewed Date:4/3/01 Date : By : . Balm . Kodery , M . S .

Radiation safety Officer

Positions Reeponsible For Review 6r -Revision: Radiation Safety Officer

POLICY: All Raioactive See& dial-d from an implanted patient during surgery ehuuld be collected and delivered to '. ' sadiation Safety Officer-

PURP0SE:To ensure thnt none of the O.R.personne1 or other

SCOPE : Interdepartmental

s t a f f are exposed to any unwanted radiation. k- 1

PROCEDURF :

he surgeon should avaid the .implanted regions as far as possible.

I f any radioactive seed gets dislodged during the procedure -do Mt touch 11: w i t h bare hands.Handle it w i t h a foreceps and placed it in a plastic container.

Preferably, pour s o m e water in the cantainer +to sfueld t h e radiation coming out of the seed.

Call Radiation Safety-Qfficer at -5039-111 hAs h e n c e , call Radiation Oncology at 5003.

Radidtian Safety -car w i l l keep the a d for decay In etorage.

'.. " .

Trinitas Hospital

RADIATION ONCOLOGY POLICIES AND PROCEDURES

SUBJECT: Stxfmtium-B9 CStrontillm Chhxide) Administration

DATE : September 1 3 , 1993

PURPOSE: TO establish guidelines to be f o l h w e d regarding t h e proper use of t h e t h e r a p e u t i c radxepkarfflaceutical S r - 8 9 (Struntiurn Chloride) at Elizabeth General Medical CeRter (EGMC) for the treatment of selected patients w i t h bony metastases.

POLICY: The following procedures will be imphmented at EGMC regarding t h e Wuper -st0zage, h a d l i n g . and u6e af the radio- pharmaceutical sr-$9 €or intravenous administration to selected patients for the treatment of bony metastases.

PROCEDUPE:

.1. The radiopharmaceutical Sr-89 ( S t r o n t i u m Chloride) will be received, stored, and processed in the Nuclear Medicine Dep2mcment of the. hospital. Since Sr-8-9 1s a b e u mixtex, xaxe n u s t be given to the proper rrse-af skrelefirrq to prevent excessively h5gh radiation levels from bremmsrahlung radiat ion. High 2 # shie ld-

ness to adequately reduce the radiation levels produced via bremmsrahlung to acceptable levels,

2. Like any other radiopharmaceutical for therapeutic adminis- tration, a&erencc to the haspital's ~ u c l e a r Regulatory-Commisski-Qn 4NRC) rmandated Q u a l i t y Management [QM) Jpsogriun m u s t be &9uelyed, This requires the proper i d e n t r f i c a u o n af the patient's ictentity before dose administration, as w e l l as, the requirement & _ a w r i t k e n prescription hy-the-Radiatxan Onco log i s t far t h e raaiopharmaceutjcal IXI be administered. T h i s prescription w i l l lut the m e - & .the patient, the name and form of the radiopharmaceutical, the etetiuity to be administered, and the route of administratian. A- to all other elements-of the QM Program will he achieved inclqding the NRC requirements regarding therapeutic misadministrations.

'\-' ing materials shaulc€ m l y be used if t k q are of sufficient t h i c k -

3 , The p a t i e n t , t h e tethnologlsts, the- nursing staff (as appli- cable) will be briefed on radiation sa.€eLy .measuxeg to be i;ny>le- mented f o r t h e use of this unsealed, beta-emitting radiopharma- ceutical. T h e major radiation - f e y c01scer~1 is to avoid-or m i n i m e the spzead of radioactive contaminatian from the u6e of Sr-89 . DLspokable gloves, and lab coats tunes- by staff d i r e c t l y handling swing?).

-I t h e

gohznss will h .used at .all radiopharmaceutical (i.e.,

'.J 4. The a c u u l t y of the S r - B 9 dose will he Y e n f i e d using the dose calibrator in the Nuclear Medicine Department prior to dose administration. While i t -is anted that the NRC does not xequire licensees to assay the activity of the beta-emitting rudfophar- maceuticals, the Sr-89 dose will be assayed with the dose cdli- brator ( u s i n g a calibration factor assigned by the Physicist), This will.serve as a c ~ s t i t n c y check and verification-of the inas++ facturer's stated activAty for the radiopharmaceutical. oncologist, after proper ly identifying khe patient, w i l l . admuus ' ' tier the r c d i o p h ~ c e u t s c l to the patient intravenously either in the .patient's room (if applicable) ar uithin .the Nuchaz-Nedicine or Radiation oncology Departments. In either case, a survey of the dose administration area w i l l be conducted a f t e x the administratian. Qnce i n p e t e d , the patient does not pose a significant source of external radiation due to -the limifPd -e of the.beta particles emitted by Sr-89. However, the patient's bodily fluids are radioactive and should be treated with caution to minimize the spread of radioactive contamination.

5. Any gloyes, alcohol swabs, JV's, et=, utilized durhg t h e in-jection must be surveyed prior to disposal. items must be stored for decay QX the waste m a y be rskuned .to the vendor (if an injection pack f r o m t he \lender i s used) far disposal. The spent syrurge should be returned t0.th.e vendor for disposal. It is noted that Sr-89 has a h a l f - l i f e of 5 0 . 5 days; a l l Sr-89 waste being stared to decay.musL be .held €m- a minimum of ten half-lives, i-e-, 505.0 day6 before survey and possible treaxment -as mra.dioact~ve waste I-dqxmdhg upen the survey readings obtained).

6. Since the -patient for -this prac&xe ty&ca.lly-xa-i& a dose of approximately 4 milaicuries of Sr-89 tStrontium Chlor/de), .the patient need not he hosp i td l i zed and may be as an outpatient. safety m e a s u r e s n e a s s a x y at home .by the Q n c o h g i s t . NRC regulat ions require hospitalization only for those patierras receiving a dose of a therapeutic radiopharmaceutical w i t h an activity equal to or greater than 30 millicuries. If medicalJy indicated, the physician may .elect to hs@LaLz ' e the -ent regard les s of the activity adminFstered to t h e patient . f f this is the case, then appropriate nursing procedures m u s t be followed, The mast important nursing procedure6 to be folhwed is to weal: disposable gloves at all times when handling the patient _ l e s p e d a l l y when handling bodily fluids). In addition, a l l containers used to hold bodily fluids 1 i . e . bed pans) should be rinsed tharrmghly before disposal. Bed linens, patient gowns, e t c . that become contaminated from h d i l y f l u i d s shtxild _he

bag, to eva luate these items for proper storage and/or disposal.

T h e R d x q t i o n

All contaminatq

\..J

~ l l Sr-89 outpatients-will be informed of any rad4ation

in a @.astic The p h y s i c i s t or- Radiation oncologist should be noti€+ed

7. Nursing care i n s t r u c t i o n s s h c n l d be aLtaclred the chart of any inpatient r e c e i v i n g Sr-89 ( S t r o n t i w q Chloride).

8 . Before t h e patient is discharged, he/she will be given instruc-

n e x t f e w weeks .

'.-J

. tions. by- the Radiation Gnco-logi-st to be follawed ;bt trOme fot t h e

Revised: October 1 2 , 199.3 October 21, 1996

APPRWED :

Medical Director D a t e

Date

Trinitas Hospital

RADIATION ONCOLOGY POLICIBS AND PR-S ,d

DATE : July 7, 1993

POLICY:

This quality management program applies to brachytherapy w i t h computer controlled, high dose rate (HDR) afterloading devices which contain sealed sources of Iridium-19p.

1. RESPONSIBILITY

Only an autharizad user (physician) and arltbnrized physicist S l Z a Z X be involved in administering high dose brachytherapy treatments.

2. THB WRI'ITKN DIRECTIVE

An authorized user shall date and sign a written directive i.J (prescription) prior to administration of any brachykherapy . dose

from a high dose rate remote afterloading device [10CFR35.32(a) (1)1' and {3.1.1}2- This written directive shall be maintained for three years. The written directive must: include:

a. The date b. The patient'tj- name - c. The total dose planned d. The dose per frdctjon e. .The treatment -sits f. The applicator type g. Signature of the authorized user physician

If because af t h e emergent nature of the patient's condition, a .the

patient's health, an ora3 directive w i l l be acceptable pr&ctr?d that the in€azma.tion -pravided in the oral dir-tiue is -ilOtwnenc4 immediately in the patient's rmorct and a yritten directive is prepared within 24 hours of the oral directive.

delay in order to provide a wriuen directive vauld jeopardue *

ftems in hxash r~ [ -1 are x e f ~ n c e s to t&e xqirements in Title 10 Code of Federal Regulations, P a r t 35.

Items in brackets { } are references to paL;aS.raphmmberr af recommendatiorw contained in USNRC Regulatory Guide 8 . 3 3 , W l i t v Manaqement Procrrgm, u'

POtiCY REVIEWED

Routine revisions to the written directive w i l l be made prior qo administration of m e dose csr-next fTactionai *e.

m -the event the written diremixre -(prescription) i s nut -ut& as directed (eg. patient died, tumor regreseed, etc . ), revisions o€ such written directives shaal be made prior to-adtnin%etr*tion of the total prescribed dose.

*-J

The identity of the patient ae the individual n a m e d in -tke wzittsn directive shall be verified by two independent methads

patient shall be to ask the patient's name and confirm the name by at least one of the fnllowing-by comparison WiLh the cozxesponding information in the patient's record: birthdate, address, social security number, signature, the name on k h e pati..ent'_s 3mspi-l -ID bracelet or hospital ID card, the name on the patieqt's medical insurance card, or a photograph of the p a t i e n t ' s face.

[10CFR35.32(a) ( 2 ) and {3.1.2}. The procedure used to iAen+lf . Y -

3 . T f p B T R l m m m r ~

3.1 TBEB TMENT PLANNING ULATXON CO-R PROGRAMS

The physicist s h a l l perform acceptance testing on each t r e a t m e n t , planning or dose calculation computer program {3.1.9}. Acceptame testing shall be performed before the firsc use of a t r e a t m e a t . planning or dose calculating computer .program far hrachythezqy high dose rate remote afterloading devices. A record of the testing and results shall be maintained for three years.

3.2 THE PROVIS IONAL PLAN

The authorized u8er establishes the target volume .in the patient using appropriate diagnostic techniques, which may include physical examination, x-ray fluoroscopy, x-ray film, MRI, OT _nrlcleax medicine seitns, On the basis of this informatian, with instruction

provisional treatment plan, t h i s is, a provisional plan of the computerized source placement and dwell times needed to accomplish the dietributian of the absorbed dose des ired.

f r o m the authorized user, the physicist ox daShneLzx3 tdeYisas.a

\ V'

3 . 3 m PRETREATMENT PROCEDURES ~t the completion of the treatment plan preparation and prior LQ the initial treatment, the authorized user w i l l r e v i e w Lhe plan w i t h the physicist or dosimetrist t o verify the plan 1s consistent, w i t h the w x i t t a .directive ( 3 . 1 . 3 } . T h i s review will .verify tkat the following i t q s on the trear-ment plan are consistent with the written directive:

a. Radioisotope

c. Source strength

e. Total dose

.h. -Numbftt- Of dwell w- d. Treatment Site

Radiographs will be obtained to verify the pnsiLioa of the dummy sources prior to treatment and shall be used in calculating the prescribed btachytherapy bf le befarrt inf3erEi.m of the npA-Pd..swtce (3.1.5).

Before adminiatering treatment the physicist or authorized user shall verify that the specific decaila of the br+chytherapy admiIlistraLioxx are in acca-spance with the written directive and the plan of treatment {3.1.3}.

L.1 DQSe calculations shall be checked. hefore adminhtering t k prescribed brachytharapy -e I10C2!5-253 and 43--lA$. An authorized user or qualified person under the supervision of a4 authorized -user wko whenever poesileh did -not rtMke the edgimsl calculation&, should cheek the dose calculations. Manual dose, calculation checks may be accomplished using 2i-r a treatment. planning eyatem, m a n u a l doae C a l C u l a t h m S or from tab19 of dose rates for spec i f ic activity brachythexapy smn.e.6.. Computer-generated dose calculations shall be checked by examining the cowuterprintout to verify that the correct input daLa far Lhe patient were usa$ in the calculat ions ( e g . source strength and dwell positions).

The computer-generated dose calculatbns far input W the brachytherapy af terloadihg device shall be checked to verify the correct transfer of data from the computer ( e , g . , Channel numb-+ d w e l l positions, and treatwent times) by the person entering the data to the treatment unit.

If the authorized-user cteterrrrirres that cklayhg the treatment in

jeopardize the patient's health because of the emergent nature of shall be performed within 24 hours of the treatment {3.1.8}.

order to $perform the checks of t h e dose I!- W D l l l d

the patient's mF?nical CfmdLknn , the rhcrrlcfi nf c a l c u 1 ~ t i a . e . .

4 . TREAlMIcNT ADMXNISTRATZON

It is the authorized user's respansihility to efsture achtirristratiun of the radioaeLive samce romnllafi ' w i t h d e sui- xiixactive and is given to the correct patient.

Immediately after each use of the afterloading device, d w q - u f t h e device, connectors and applicators will be performed to ensure that the source has been returned to the fu l ly shieldedgnsition. Each brachytherapy patient shall be monitored f o r radibaetivity w i t h a aurvey meter hPfnre and at%ex m-tre-aGzaent - d i a d the -rQ81;11t recorded and initialed by the physicist or authorized userJ.

.After each brachytherapy treatment, the authorized user shall sign or inirtiral a recard of the administered t r e a t m e n s $ ! - Zhhxeccux3 shall be maintained for three years [10CFR35.32(d) ( 2 1 1 and {3.1.7}.

Any individual who i s uncertain about any a.specC of the &xeament shall seek guidance and ask questions before initiating any procedure { 3.1.4) .

Unintended deviations from the written directive include misadministratione and ~ e c ~ l . e SVXY~CS w h i c h -are &€bed in 10CFR3S. 2. When a mi6administratian QCCuz-6, notif icatFon of the

given in lOCFR35.33. NRC, the referrut 9- * 'anand tbepatistlt must foll-ow gu-ideliftes

When a nlrecordable event" n w s , -all relwent €acts aust &.e assembled and appropriate actions taken if I I W ~ B S ~ X - ~ . A writken record of the relevent facts leading up to the ev_ent and any actions taken to prevent similar events must be prepared within 30 days of recognizing the = M e event. This reard QF zqxwt w i l l be submitted to t h e Radiation Satfety Committee for revkew gnd a copy of the report will be maintained in the hospital files.

unintended deviations frm the written airective will b e investigated by the medicdl director .th zhe bBSisMaace o f the physicist and Radiation Safety Officer.

L.-J ' Policy and Guidance Directive FC 86-4 , Revision 1,

6. QUALITY MANAG- PROGRAM

A formal review of t he quality management program will be lMde ht. least once every 12 mnrhs IlDCFR35.32(b)J and ( L L - U } . !I!he program w i l l be reviewed by the physicist. Twenty-five or 2Q percent (which ever is greater) of the written directives generated during the 12 month period under consideration w i l l be rev4ewed. 'If less than twenty-five ca8m are _pesformed then 100 p e r m of chis casee will be reviewed, This review w i l l ~ ~ C Q ~ R ~ E ~ E E the writtea directives, computer treatment.plans/dase c&Ulathns 1 .ueatment recards and assachted docume-nq pertaining to the planning and administration of the treatment.

The physicist and the aervica engineer w i l l implement an annual, radiation safety seview which -will include a -dry run of the emergency prqcedures - The date and attendance of this exercise will be documente . The records of recordable events of administxations QccuTTip9 &I t h e 12 monch period w i l l be-reviewed f 4 t promptness and throughness of the investigations, apprpriateness af .actinn(s) -cakes (if any) and will include a review of the succeeding five written directives (if available) f-rom s i m i l a r administrat i a ~ s te-svaluate the effect of any action that was taken.

?

If any misadministratian or remrdahle event .is uncoverwi duritlg the periodic review o€ the program , the number of cases r e v i d w i l l be expanded a6 deemed necessary by the Medical DDireCtQr _and physicist.

The reviewers will e v a l m e the noverdL1 ef2ectiven0&s of t k qualby management program and the need for modification of the progrqm.

A report by the individudl perfarming _the review, w i l l be-submitted to the Radiathon Safety C a m i ~ t e e €or r e v i e w d a copy w i l l be maintained in the hospital f i l e s for three years.

Changea to the quality'management program w i l l be dOCUInente& implemented and s u b m i e e d to the NRC for xtsriew w i d i n 30 daw rlOCFR35.32 (e) ] .

7. RBCORD KgBPfNG

The written directive-will be maincaineb f o r thee years.

A record of the acceptance teeting on each treatment planning computer program for HDR remote afterloading device IxachyWiexapy will be maintained for three years.

Each brachytherapy patient shall be monitored for radioactivity with a survey meter before and after each treatment and the result recorded and -siyned by . a e QhysiCist or authorized user. T h i s record will be maintained for three years.

A f t e r each brachytherapy treatment, the authorized user shall tiate

Thia record shall be maintained for three years.

R record of rcar;dable events w i l l be ak?intained i n thc -tal f i l e s for three years.

Records of all formal -Twiws af &he QuaUty -Maaagefnent -Program will be maintained for three years.

. . and sign or i n i t i a l a record of the treatment/dcMse.

'.../e Revised: November 5 , 1996

Approved :

If / 4 ./?.b Medical Phys i c i o t J d$e

Medical Director Radiation Oncology date

Radiation Safety Oflicer -. -A$--

Trinitas Hospital RADIATION ONCOLOGY POLICY 6 PROCEDURE

SUBJECT: LEAK TESTING OF BRACHYTHERAPY SOURCES

DATE : September 16, 1992

POLICY : Leak testing of the brachytherapy - ~ ~ 1 1 l c e s . s b l l be conducted by the physicist and reviewed by the RSO on at least a semi-annual b a s i s .

PRoC~DZIRE: 1 a L l leak test samples shall be analyze& u s i n g appropriate instrmntaLan using Uze m e t h o d de- scribed in Appendix H, m o d e l procedure for leak- testing sealed sources, NRC Regulatory GuUe lo,&, Revision 2 . T h e license ac t ion l e v e l for radio- active leakage is 0 - 0 0 5 microcuries- -* an iiccqztaple leakage r e s u l t i s less than 0.005 microcuries.

2.Leakage greater than t h i s requires the source to be withdrawn from use.

3.Notify the NRC immediately.

*g&G& /fL K. Ztd feste, RN, Adm. Director

E, P i n k e l s t e i n , M.D. Medical Direct r q

FOLiCY REVIEWED

Init: b' Date: ' I )b t

\..__.;

Trinitas Hospital

RADIATION ONCOLOGY POLICIES AND PROCEMJRES

DATE : December 2 6 , 1991

POLICY:

This quality manafpnent program appLkS Co . m v y procedures w i t h low dose rate sealed sources.

1. RRSPONSfBILITY

Only an authorized user Qbpic ian) and ather autfwrized individuals (physicist, dosimetrist ete. ) shall be invoxved in administering brachytherapy treatments.

2. THE WRITTXN DXRECPIW

A n authorized user shal l date and -sign a w r i t t e n .dimxtiVe (prescription) p r i o r to administration of any brachytherapy dose

'- 1 from a high dose rate remoLe afkfsdoddkg device [10CFR35.32[a) (1) 1' and (3.2.1)'- This w r i t t e n directive shall pe maintained for three years. The written directive must include:

a . T h e date

c. d. The radioisvtope e. The number of s s u r ~ f. The approximace source strength g. Signature of the authnrized ueer phjtslician

b. The patient 's -name The -tal dose tohe admaai-st-ezx?d Qr tot-sl tzeatment t h e

If because of the emergent nature of the patienL's - cmd~L~ ' .on, a delay in order to provide a written directive wuuld jeapardize the patient's health, an oral directive w i l l be accepL.abls pra~idad that the information provided in t h e oral directive i s CiocumenLed inxnediaLeQ in t he patient's -a& -a nr- ive is prepared within 24 hours of the oral d irect ive .

Items in brackers 1 1 aze a z m c e s to the requirements m

Items in brackets { ] are referewes to para- mmhrs uf L' recommendations cofttairrecl in VSrJRC R e g u l a t o r y Guide 8 . 3 3 , Qua litr

Title 10 Code o f Federal Regulations, Part 35.

-m ent Proargm,

POLlCY REVIEWED

Routine revisions ta the written cfirizctive will be made prior 90 administration of the dose ornext fractional W e .

In the event the written directive lprescrLpiha) iu not executed as directed leg. patient died, tumor regressed, erc. 1 , rwis-ions crq such written directives shall be made prior to a d m i n i t i m a of the total prescribed dose.

'"2

The identity of the patient as she -iadivh&zal named i n the w r i t t e n directive shall be verified by two independent methods, [lOCFR35,32(a) (2) and (3.2.2). The -prrzcedrure uaed to -i&nti€y the patient shall be to ask the patient's name andconfirm the name figc at least one of the following by comparison with &crnrreqmndixag information in the patient's record: birthdate, address, social security number, signature, the name on the patient's haspiral 1D bracelet QT hospital- u3 c u d , the name on the paLiynt's medical insurance card, or a photograph of the patient's facfp.

3 . THgTRgATMgNTPLAN

The physicist shall perform acceptance t e s t ' on each tratamnt planning or dose calculation campucer programT - 2 - 13). Acceptance testing shall be performed before the first use af a txeaunent planning or d06e calculating computer prbgram for brachytherapy . Accuracy of the treatment planning system w i l l be determined h y comparison with manual calculations and/or cQmparison with other treatment planning syatems, -A zemzxi of the t6t&g -arid -its shall be maintained for three years.

L -4,

3.2 T B P ROVISIO NAL PLAN

The authorized uaer establishes the target vulume in t h e patierkc

examinatbn, x-ray fluoroscopy, x-ray film, CT, MRI, ultrasound or

instruction from the- autharizecl mer, the physicist or dosimetlrkk

of the source placement-and treatment times ngeded to accomplish the distribution of the absorbed dose desired.

using appropriate diagnostic E e d m i q u e s f which may inCAtt$e -physisll

nuclear medicine scans. O n che basis of Zh is R, w i t h

devises a provisional treatment plan, this i s , a provriaiaDal e

3 . 3 E PRETR EATME NT PROCEDUBE_ S

At the completion of the tzeament p l w preparation and pripr to the administration of the treatment, the authorized user will review the plan w i t h the p h y s i c i S DT rlnalmP trist ts verify the plan is consistent with t h e written directive f3.2.5). This revlqw will verify that the following .items 4R the tr-eatmexst -plan are consistent with the written directive:

a. RadioisorJnpe b. Number of RWLCW c. Source srrengths d. Loading sequence, if a-pplieqle e. Total dose or treatment time

For temporary brachytherapy implants, radiographs or o the r comparable images w i l l be nhtainPri & v-ify t;ke-positien of dummy sources in place as the basis for verifying the position of the sources and calculating exposure time ox dase, -For -fM -geoffietry applicators, source locatinn and exposure time or dose m y be determined by the applicator (provided the_position of che sauces within the applicator is known) I3.2.6).

Before administering Lhe Jzachyzherapy d~#, the physicist rn authorized user &all verify thaz the speciffc details of the.

.J brachytherapy administration are in accordaace r i c h the -written direccive and the plan of trestment (3.2.3).ThSs may be accomplished by comparing one of the following: the xmm&aaurex'~ stated isotope and act iv i ty , the aQuTce drawer loading diagram QX color coding. In addition, the number of s~uzces SRWld-be verifW by councing.

4 . "RBA2?4ENT ADMINISTRATION

It is the autharized user's rertporrszbility to ensure admknistratrm of the radioactive source axpLiss w i t h tke urittin-direetive -ad is given to the correct patient.

For permanent brachytherapy imp&m&s , rad-iogr+phs or -otjxer comparable images will be obtained of the rad5oacrtfve sources in place, for verifying the positian nf _the sou~cea ax3 dfi elte -bas* for calculating t a t a l dose, if applicable.For fixed geometry-

determined by the applicator (3.2.3).

Dose calculations shall be checked -hefore f i f t y of ttze prescribed dose has heen administered. An authorize& user or qualified individual under the supervision of the autkcrri- wer, who whenever possible did m t make the or5giaal c a l c u h t i m ,

applicators, source location and t o t a l dose (if apBlicabL e) -=y-be

\/'

. ._

should check the dose c a l c u l a t i a s . Manual dose calculations 8hou1d be checked for arithmetic erroz8, appropriat+ trantlftr af *ta from the written directive, plan of treatment; tables and graphs, appropriate use of nomograms ( w h e r e app1icahJ.e) and appropriate use of pertinent data in the calculat ion. Computer-generatea dose calculations should be checked by examining the c v r -printout to verify that the correct data for the patient was used in calculations (eg. position of the applicator or sealed sources, total source strength, number of saurcea or: loading fequencej. Alternatively, the brachytherapy dose should be calculated m a m a l l y to a ailrgfe key point. N o t e : If manual calculations are perfonned, using computer-generated outputs (or vise-versa), particular emphasis shoufd beplacea on verifying the correct output fram q e type calculation feg. comprter) to be used as iap.ut in-irrrotker type calculation (eg. manual) (3.2.10).

If the authorized user det%rarines that delaying t h tregtment in order to perform t h e checks of the dase calculaEions would jeopardize the patient's health hncnllnR af the -emer=nt natwe of the patient's medical condition, the checks-of t k e e calculations-

brachytherapy treatment (3.2.12). shall be performed w i t h i n t w o wnrklnq * -days bf comp&etitnl -of t t r e

A f t e r insertinn of a Eempzary&~hy€&rapy h p h n t t h a a t h u r 5 z e d user w i l l promptly record t h e actual source loar3fng sequence an& initial the record (3.23)- After inse~%.i-on of a pemanent brachytherapy sources the authorized user w i l l promptly remrb- t h e actual number of radioactive SOUTCBS implanted .sad AJ+it-i;al tke record (3.2.9).

Any individual who is uncertax~ zibalt-asy-sspect of the tTemmenz shall see& guidance an& a& qne=ions before initiating any procedure { 3 . 2 . 4 } .

Unintended deviatbna from the written directive h c l u d e misadministrations and recordable events w h i c h -are defined in 10CFR35.2. When a misadministration occurt3, notification a€ *e M C , the refexzingphysician-and the pa-tkent must -fa~lvwyn&3el.ines given in 10CFR35.33.

When a "recordable evenL" occur8, all reLevent €-%cts must be assembled and appropriate actFane taken if necwsary. A written. record of the relevent facts lending up to d e event irnd m y actions taken to prevent similar event6 m u s t be prepared within 3Q days of recognizing the recordable event. T h b o r repert will be submi t tedta the Radiation Safety Committee f o r revhvrand a copy of the report will be maintained in the hospital files.

Unintended deviations front the written directive will be investigated by the lnedical -director w i t h tke -as&starrce cii the physicist and Radiation Safety O f f i c e r .

6. QUALITY MANAOBMENT PROGRAM

A formal review of the quality management program will be made at- least once every 12 m-hs J.10CFR35.32(b)1 and {3.2.14+. The program w i l l be reviewed by the physiciot. Twenty-five or 2 0 percent (which ever is greater) of the w r i t t e n - d k c e - c t i v e r J generaced during the 12 manth period. under consideration will be reviewed. If less than twenty-five caaes areperformed then 100 pezcenz of ttze cases will be reviewed. This r e v i e w will encompas~ the written directives, computer treatment plano/dose calculations, trea+_mant records and associated documents pertaining tu the planning and abrrrjlnfstrat5an of t h e treatment. For each pat ient case the review will determirre whrzcbqr the administered dose was in accordance w i t h the written directive.

The physicist w i l l hplemPnt an -aaaual r-itdizttien *y r e v i e w in accordance with regtrlatary guide 10.8. The date and attendance of- this review w i l l be documented.

The records of recordable events of administratfons occurrirrg in the 12 month period w i l l be xmriewed for -prorrrptnees 4 e-ws of the Fnuestigations, a p p r a p r i a ~ 8 of t h e a c t b n ( e ) taken (i€ any) and will include a review of _the aucceedlzq f i e -wri t ten directives (if available) from similar adrninis€ratiane to -evaluate- the effect of any action t h a t was taken.

If any misadminiseeation or recczrdable event is uncovered- during. the periodic review af the -gwn.gxam , -the w&er of eaees swimued wzll he expanbed 88 deerned: necessary By the Medical Director and physicist.

The r e v i e w e r s will evaluate the overall effectiveness of the quality nranageffent proqratn d-Rd -the m?wd for mbdiTicat ion o€ the program.

A report by the individual gx?r$oz#iag the -re*, #ill.-be-F;nfimitted to the Radiation Safety C a m i t t e e for revirew and a copy w i I I be maintained in the hospital filesfor three years.

Changes to the quality management program U -he documented, implemented and submitted to the NRC for review within 30 daw; [10CFR35.32 (e) 1 .

7. RECORD KBRPING

The written directive will be mint-ained far three years.

A record of the acceptance testing 0x1 eacrkr tre&merkt p l d m i q computer program for HIlR xemoce -afterloadhg -device ixachyrherapy will be maintained f o r three years.

Each brachytherapy ' shall -be -nit& for Tadirmrtivity with a survey meter before a d a€ter each treatment and t h e result recorded and signed by Lhe pkjlsici-st of -authorized mer. T h i s record will be maintained for three years.

After each brachytherapy treatment, the sutharized u r n shall date and sign or initial a record of thet administered treatmentfduse. This record shall be maintained for Uxee pars.

A record af xecordable-eve&* -will -be mailztahed in the hospital files for three years.

Record8 of all farmal review of the Quality Prcrgram will be maintained €or three years.

Revised: .Nover;lber -6, 1396

Approve9 :

Medical D i - ~ e c t o t .U&at-ion 'Oncology date

SUBJECT:

DATE:

POLICY:

PROCEDURE:

TBWITAS HOSP€TAL RADIATION ONCOLOGY POLICY dk F?RfM22Y?BW%W

J.

2.

3.

RECEIPT OF BRACHYTHERAPY SOuRCFS

qepternber 16, 1992

The receipt ofhachythempqrsourceeat Trhdtad .Hospital shalt be in accordance with both tht h p i t a t ' s NRC license and the model guieSnee €erorcl+ringdreceivling radio- active materials that was ptrtished in Appendix K of NRC 3kgulafmyGuidc HIS, Revision 2. 'fhe brachytherapy sources desired by the radiatiM o-sha.ll-- by the RSO or his designee.

J k € O ~ a n j L ~ ~ d e d , & e * ~ pkmgdle order &ai€ ckeck dxat the hospital's NRC license aftow the pmesskmtmdweeftheradianticiidetok ordered. €fin doubt, the mdividual. sfroukd double check with the RSO or -hndcsignees, i.e.,*e radialion oncologist and/or the radiation physicist before placing any order for brachy- therapy sources.

No radioactive padcages will be -red by fecarritjr personnel or receiving department for later dtsvery to the -- Upon receipt of the d e l i ~ ~ in she-- department, the radiation physicist shall perfbrm a package

s m e y (utilizing -a appropriate +wrvey meter) d t f n shipping container at both thxee feet from an at the shippirrg- 4xm&eTswfiKx. -Radiation -kv& measured must be acceptable for the type of DOT label attached to the -shipping container. For a "RADIOACTIVE - WHII'E I" label, the acceptable dose rate Iimits are less than or equal

te 0.5 mRh. (suEEace). For a “RADIOACTNE- YELLOW H” laeel &eaccqtablo dose rate limits are less than or eqnal to 50.0 mwhr. (sutfacc) and 1.0 mWhr. (b &et). For- ‘ m - m - n L L o w m” label, dt% a~~cptablo dose rate limits are less than or equal 10208.0 mR&r.fsmface) and 10.0 mwhr. (thtce ha). If readiffgs; are higher than listed above, contact the BsU-fiw- immctions. Radiation lev& abwe these li&s fn%Mfate‘

4Y that both the NRC and the DOT bo conuwedimmedna for g u i b c c . Do not open up my m g e s with radiation levels higher than the abweststea a limits. The receipt of the radioactive scwces inchtding the number of sources, the hdividualvd Ectal acthities receive and the measured package dose rates shall be documented in the appropriatehg-bedr. (Please d e r tcs the hespita;l’s-NKC--ieenstfbr additiod Tinfcmation on this topic.

Revisd July 2002

9 vd 'trinitas Hospital

'id' RADIATION ONCOLOGY POLICY 8 PROCEDURE

SUBJECT: STORAGE OF BRACHYTHERAPY SOURCYS

DATE: September 16, 1992

POLXCY t All brachytherdpy &ources are Stured in the locked, radioactive materials s€orage room (located within the rad in t ion oncnlogy departmentj. All cs-137 brachytherapy tube sources are stored w i t h i n a locked, fireproof, properly shielded -safe ( loca ted w i t h i n the radioactive materials storwe room). Those sources ordered for tempsrary me., e . g . It-192 seeds, are stored in their original shipping container within the radioactive matexials storage room. proper tra ining and specific aukhorizakian axe granted access to t h i s storage room.

PROCeDtfRe:l.The entrance of this r e o m is pes4x?dwitfi a radio- attive w a r n i v q sigm i n d i c a t i n g the presence & radioactive materials w i t h i n the room.

Only those i n d i v i d u a l s w i t h a y e d ,

2,The l i s t of individuals authorized to handle brachy- therapy sources, 11s w e l z - ~ t s , the po l i cy for the proper handling and use of these sources are a l so posted outside the room entrance.

Q c k f j - \ k S 'G *Is Date Robert Silbey M.D&, RSO

4 '

K: Ceifeste. RN, Adm. Director Date

Medical Pizector

'd

, L.1

TRlNfTAS HOSPITAL RADIATION ONCOLOGY POL1 4-PRAX?%BtfRiC c4w

s-m: SulcvEY OF BRAtXYTHEWPY SOURCE STORAGE AREA

DATE: September 16,1992

POLICY: Surveys c3f the brachytherapy storage room(uti1izing an Appropriate-su~veynt.tcr)and 3sadjacem ~zcgg are conducted by the physicist and reviewed by the RSO on at least a quarterly basis. Tk: dor#.ratekvels-xgea& must be less than the license action level for ambient dose rate.

2. Any missingsautces 4 i & l m l d ' b y & i s i l w u w q f q * h Immediate notification to the RSO and an investigation of 4 e source loss.

Date &9

Medical Director

TRINITAS HOSPITAL

ITEM 9

Radiation Monitoring Instruments

(A) Radiation Survey Instruments will be calibrated yearly by a qualified person to perform such calibrations. ( We will send out our meter to our radiopharmaceutical vendor, who sends it to a calibration laboratory that meet the requirements in 10 CFR 20.1501 and of 10 CFR 35.61.)

(B) Radiation Well Counter will be calibrated yearly by our consulting physicist, who will follow nationally recognized standards or the Manufacturers recommendations.

The Survey meter is a Ludlum 14 with a 44-9 GM Pancake Probe. This unit will be used for Daily package surveys of incoming packages, daily area surveys, daily monitoring of hands and feet, and for monitoring waste prior to disposal.

The Well Counter is a Biodex AtomLab 930with Biodex Well. This unit will be used for daily wiping of Incoming and outgoing radioactive packages, and for weekly area wipe testing for contamination.

We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used.

Dose Calibrator

Equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufactures instructions.

Gamma Camera

We will perform all Quality Control and Calibrations that are in accordance with nationally recognized standards and manufacturers recommendations.

Thyroid Uptake Probe

We will perform all Quality Control and Calibrations that are in accordance with nationally recognized standards and manufacturers recommendations

TRINITAS HOSPITAL

Item 10

Occupational Dose

We will provide dosimetry that meets the requirements listed under criteria in NUREG 1556 , volume 9 “ Consolidated Guidance about Materials License: Program Specific Guidance about Medical Use Licensees.”

Area Surveys

We have developed and will implement and maintain written procedures for area surveys In accordance with 10 CFR 20.1 101 that meet the requirements of 10 CFR 20.1501 and 10 CFR 35.70.

Safe Use of Unsealed Licensed Material

We have developed and will implement and maintain procedures for safe use of unsealed byproduct that meets the requirements of 10 CFR 20.1101 and 10 CFR 20.1301.

Spill Procedure

We have developed and will implement and maintain written procedures for safe response to spills of licensed material in accordance with 10 CFR 20.1 101.

Item 11

Waste Management

We have developed and will implement and maintain written waste disposal procedures for licensed material in accordance with 10 CFR 20.1 101, that also meet the requirements of the applicable section of Subpart K to 10 CFR Part 20 and 10 CFR 35.92.