thyroid and diabetes management center, …thyroid and diabetes management center 8939 broadway...

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Thyroid and Diabetes Management Center 8939 Broadway

Merrillville, IN 46410 PH:219-736-5077 FAX:219-736-9316

March 3 0 , 2006

U.S. Nuclear Regulatory Commission Materials Licensing Section 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352

Dear Sir o r Madam:

The Thyroid and Diabetes Management Center would like to amend its NRC Byproducts Materials License, Number 13-32380-01. Specifically, we request that Richard S. Longley, M.D. be authorized to treat thyroid carcinoma patients using sodium iodide 1-131. Enclosed is NRC Form 313A documenting Dr. Longley's involvement in three carcinoma treatments, signed by a preceptor.

If there are any questions concerning this license amendment, please contact o u r nuclear medicine consultant, Mr. Patrick J . Byrne, D.A.B.R. at 877-317-5811.

Sincerely,

Richard S. Longle;,M.D. Radiation Safety Officer

RECEIVED APR 1 8 2006

NRC FORM 313 U. S. NUCLEAR REGULATORY COMMISSION I uTRovcDny OM* wo-l’JM’?o

m W F E E F E E L f f i FEE CAE-Y AMOUNT RECEIVED CHECK NUMBER

I A ~ O V E D av DATE

SEhD -NO COPIES OF I*€ EhT.RE C3MPLETEO APPL CATION TO ThE hRC OFFCE SPEC.F,ED BE-OvZI

-Tyh MI U S r n l W K Y W uDln PRoMR3S flu -1yw V.lw lr ?a, IJU L a A l W I*

COUMENTS

CCUNECTICLII. DLUWMC DISTRICT W U X U Y O h W N L MbKVUNO. I *LYCWW~S, NEW wm(li~+ NEW J M ~ . N ~ W r o w ~ W Y L V U ( I * . R m c o a uuyo. mvLIuy*(1. rorovruumw T O

LCENSlNG ASSUTANT S€CV% YUCLEAR MATERIALS S A F m BRANCH U S YVCLEAR REGULATORY COMMISSION REGION I 47s ALLENOALE ROAO I(IHG of PRUSSU PA l m I 1 l S - FLORIM O E D R O ~ U E N T U C ~ MIUIUIP+I wanin CAROLINA PUERTO

RICO -TU CMOUNh TENNESSEE. VlROINlh VIROIN I U D S . OR WEST VlROIN4 SEIIO - IUTY) *S TO

NUCLEAR MATERIALS LICENSNG S E c M w l i S NUCLEAR REGULATORY COMMISSION REGION II

$01 MARIETTA STREET W S u m lem A U N T * GA )LIIIY)l’X

NUCLUR MATERIALS LICENSING SECnON U S NUCLEAR REGULATORY COMMISSIOH REGION IV

611 RVAN RIL* DRIVE. S U E 4CU ARLINGTON TX 7 g r l s O S r

PERSONS LCCITEDIN AOREEMENT STATES SENDlPDLlCATlONS TO THE U 5 NUCLELR REOUUTORY COMMISSION ONLY IF -HEY WISH TO WSSESS A N 0 USE LICENSED *A-ER#AL Y L T l i E S SU-ECT -9 u S HUCLUR R E C I U U T O l l l COMIIISSIOH -YRISOICTIONI

2 NAME AND MAIUNG AWRESS OF APPLICANT 11osI- L P -.I 1 WIS IS AN w w c i n o N FOR icmx P PO PI.. im)

A H W M FEE CATEMRY 1 ENCLOSED 1

11 WASTE MANAGEMENT

11 CERTIFUl ’Wd (Must t. m m p - Dy .pp”unl) THE APPLICANT UNDERSTANDS THAT A U STATEMEMS AND REPRESEMAnONS MADE IN WIS A P U K A m ARE BlNDlNG UPON THE APPLEAM

5. Radioactive Material - 1-131 - oral capsule dose

6 . Purpose - 1-131 therapy f o r Thyroid Cancer

7. Individual - Richard S . Longley,M.D. Responsible

8. Training F o r - see attached Individual

9. Facilities - Thyroid and Diabetes Management Center-8939 Broadway Merrillville, IN 46410

10. Radiation Safety - A L A R A - see attached Program

1 1 . Waste Management - Cardinal Health

12. Fee included - see attached

hNRC FORM a13A U.S. NUCLEAR REQUUTORY COWUISBION I

~

OTHER

?

4 2W3r

MEDICAL USE TRAINING AND EXPERIENCE I AND PRECEPTOR ATTESTATION APPROVED BY OMB: NO. 316041: EXPIRES 1013112wS I I

PART I -TRAINING AND EXPERIENCE Note: Descriitions of training and experience must contain sufficient detail to match the training and experience

criteria in the applicable regulation (10 CFR Part 35)

1. Name of Individual, Proposed Authorization (e.g.. Radiation Safety Officar). an3 Applicable Training Requirements (e.g., 10 CFR 35.50)

Z t c h t r j . 5. ~ o n g l t y , M.b. ; l- l3\>33m(- 'a ; I C CFR 35.39'4

2 For Physiuans, Podiatnsts, Dentists. Pharmausts - State or Temtory Where Licensed F-M6

I 1 R i & f)<R

3. CERTIFICATION a. Provide a copy of the board certification. (Stop here ifapp/ying under 10 CFR Part 35, Subpart J or35.590(a); I continue i f applying under other subpaIts.J . . . . b. Provide documentation in ap ro date items 4 through 10 of trainin or clinical case work required by 35 50(eJ

35.51f); 35.290fcbl)(ii)(G) gr 1" seeking 35.200 authorization; 3!5.390(b)(l)(ii)(G): 35.396(4)(1) and 35 39 (d)(2), 35.59 (c). or 35. (c).

c. Provide completed Part II Preceptor Attestation, Items l l a through l l d Stop here afler completing items 3a. 3b. and 3c when using board certification to meet 10 CFR Part 35 training and exoerience reouirements.

I 4. INDIVIDUALS IDENTIFIED ON A LICENSE OR PERMIT AS RADIATION SAFETY OFFICERS IRSOI. ,----,. . .- . . .- -. .- - .- -. . . .. -. . . . -. - -. . - - -. . . -. . . _ _ . - .- .. . . . -. . -. . . -. . -. . . - -. . - AUTHORIZED USERS (AU), AUTHORIZED MEDICAL PHYSICISTS AMP), OR

AUTHORIZED NUCLEAR PHARMACISTS IANP) SEEKING ADDITIONAL A I THORIZATIONS a. Provide a copy of the license or broadscope permit listing the current authorization and (b) or (c)

b. Complete items 6c (and 10 when training is provided by an RSO, AMP, ANP. or AU) and preceptor items 1 l b througt 1 I d to meet requirements for: RSO in 35.50(~)(2) or 35.50(e); or AU in 35.290(c)(l)(ii)(G) or 35.390(b)(l)(ii)(G) or 35.590(c) or 35.690(c); or AMP under 35.51(c).

c. Complete items 5,6a, 6b. 10, and Preceptor items 1 l a through 1 I d to meet AU requirements in 35.396(a)

5. DIDACTIC OR CLASSROOM AND LABORATORY TRAIN11 ~ - ___

Descrlntlon of Training -I LocaUon

Mathematics Pertaining to the Use and Measurement of Radioactivity I IC

Radiation Biology I ~

1 1

t -- I 1 1 Chemistry of Byproduct Material for

Medical Use I

(optlonal for MdIt ..__

Clock Hours

Physlcbb)

Dates of Training ~

-

PAGE

tc FORM a m zwbl

us. NUCLEAR REGULATORY cowwiom MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (contlnued)

6a. WORK OR PRACTICAL EXPERIENCE WITH RADIATION

Name of Supewlslng Indlvldual(s)

~.

-~ Location and . ’.

Corresponding Materials License

~~~ .. ~. .. Number ~.~

5% WWY ( k r 7 .

.

8b. SUPERVISED CLINICAL CASE EXPERIENCE (describe experience elements In 6

lndlvldual Materials License - ~- _. - _ _

-- t ---I

- Dates andlor

Clock Hours of

Experience

q- r7- lO0’r

Hours of ~ Ezrience

q- 27- 1M 4

NRC FORM 313A (4.2005)

U.S. NUCLEAR REGULATORY COMMISSIOI

MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

10, SUPERVISING INDIVIDUAL - IDENTIFICATION AND QUALIFICATIONS

The training and experience indicated above was obtained under the supervision of (fmom than one supewising individual is needed to meet requirements in 10 CFR Part 35, provide the folloMng information for each) :

A. Name of Supervisor B. Supervisor is:

Authorized User Authorized Medical Physicist ~ ~~ -3 * Y G ~ ~~~ K - - u ~~~~~~~ ~~

C. Supervisor meets requirements of Pari 35, Section@) 3 9 c ~~~~~~~~~ .~~~ .

Radiation Safety Officer Authorized Nuclear Pharmacist

for m e d i d uses in Part 35, Section@) I 7 u o , 1o_s c<r,,t 0 i, ... ~

D. Address E. Materials License~Number

1 3 - 0 3 Y 5 1 - 0 3 15-00 5. - LPKF rPnr pue. i 4 D P P F 7 , I r J . y a y 2 .~ .- ~~

PART II - PRECEPTOR ATTESTATION Note: This part must be completed by the individual's preceptor. If mom than one pmceptor is necessary to documenl

experience, obtain a separate rem for statement from each. This part is not m9uimd to meet training reouirements in 35.590 O r ~arP35. &bDart J (excent 35.980).

I attest the individual named in Item 1:

8 11 b. Select one

0 fl N/A

has satisfactorily completed the requirements in Pari 35, Section(@ and Paragmph(s) 3 '5. 3 5 ? ~ ~~ I

as documented in section@) 6 b ofthis form.

meets the requirements in 0 35.50(e) 0 35.51(~) 35.390(b)(l)(ii)(G) 0 35.690(c) for types of use, as documented in section(s)

~ .......................................................................................................................

of this form. ~~~ ....................................................................................................................... I 11,.

I 0 a

has achieved a level of competency sufficient to independently operate a nude= pharmacy (for 35.980); Or

has achieved a level of competency sufficient to function independently as an arthorized

has achieved a level of radiation safety knowledge sufficient to function independently as a Radiation Safety Officer for a medical use licensee ; Or

-C uses (or units); Or .. LL52.r LLL33.Y. ........

n N/A l ld .

0 I am an Authorized Nuclear Pharmacist; Or @ I am a Radiation Safety Officer; Or

I i~ i meet the requirements of 35 ,3 7 0 section(s) of 10 CFR Part 35

or equivalent Agreement State requirements to be a preceptor AU or 0 AMP

forthe following byproduct material uses (or units): 2- \ 3 ( P C P - i ; , j~~(, p , - ~ 3 3 h G ............ .- ................ . . . . . . . . . . . . . . . . . . . . . . . . . . .........................................................................

B. Materials License Number A. Address 5x b P R y m E o ; c p ~ CFnlTFR '500 5 . C P K F P P r r k p v G . H D b k - 7 ,XN. Y63

i3 - 0 3 4 5 1 - 0 3

~~~~~~ ~~ ~ ~~~~~~~~ ~~~~~ . . ~~~~~~~~~ ~~~ ~~ ~~ ~

E. DATE - / I ' N - 0 5

Y PAGE

NRC FORM MJA (C2Cc51

U.S. NUCLEAR REQUUTORY COMyISSIOh

MEDICAL USE TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

6c. TRAINING FOR - SECTIONS 35dO(e), 35.51(c), - 35.590(c), or 3A690(c) _ _ ~~~

- __ Name of Progra and

Correspondin Degree, Area of Study

Residency Program ._ License Lzz:a\/ Number Dates

Type of Tralnlng - - ~ -4

- . Name of Organization that

Approved the Program (e.g., Accreditation Council

for Graduate Medical Educatlon) and the Appllcabk Regulation

(e.g., 10 CFR 35.490)

Location and Dates ~ . .

Types of training may include supervised (complete item 10 for 35.50(e), 35.51(c). and 35,69O(c)), didactic, or vendor training.

7. FORMAL TRAINING Physlclans (for uses under 35.400 and 35.600) and Medical Physicists

8. RADIATION FULL-TIME EXPERIENCE

0 YES Completed 1 year of full-time (in areas identified in item 6a) under supervison ~

0 NIA of . .-a the RSO for License No

9. MEDICAL PHYSICIST -- ONE-YEA~ULL-TIME TRAININGWORK EXPERIENCE

0 YES Completed 1 year of full-time training (for areas identified in item sa) in therapeutic radiological physics

who is a medical ~ -~ ~ ~~~~ ~ ~ ~~~

0 N,A (35.961) or medical ~~~~ ~~~~~~~~

Authorized Medica Physicists (35.51);

~~ ~~~ ~ ~ ~~ ~ ~~ ~~ ~~~

YES Completed 1 radiation therapy services described 0 NIA and for

who is a medical physicist (35.961) or meets ~. . ~~

under the supervision of

requirements for Authorized Medical Physicists (35.51) (specify use or device) ~~ ~ . ~~~~~~~~

Successfully Completed the Nuclear Thyroidology Course

Iodine 131 Course on

October 17-24, 1998

Has completed its 80 hour course on the use of Iodine 13 1 for the treatment of hyperthyroidism and thyroid carcinoma

P.06

Appllcablltty Table

8.1 8.2 9.1 9.2 9.3 9.4 9.5 9.6 10.1 10.2 10.3

10.4 10.5 10.6 10.7 10.8 10.9 10.10 10.1 I 10.12 10.13 10.14 10.15 10.16 11.1 11.2 12.1 12.2

Tralnlng Program Other Training Program Faclllty Dlagram 8 Equipment Lit Survey Instrument Callbratlon Dose Callbrator Callbratlon Personnel Monltorlng Program Mobile lrnaglng Equlpment QA Other Equipment and Facilities Radlatlon Safety Commlnee A W Program Sealed Source Leak Tests

Safe Use of Radiopharmaceuticals Spill Procedures Ordering and Receiving Opening Packages Unft Dose Records Multidose Vial Records

Mo-99 Concentration Records Implant Source Use Recards Area Survey Procedures Air Concentration Control Radlophermeceutlcal Therapy Implant Therapy Other Safety Procedures Waste Dlsposal Other Waste Disposal Quality Management Plan Attenuation Correction Source

Enclosed NIA Enclosed Per 10 CFR 35.51 Enclosed Enclosed NIA N/A N/A Endosed Per Appendlx H Regulatory Guide Enclosed Endosed Enclosed Enclosed Enclosed Enclosed Enclbsed

Enclosed Enclosed Enclosed NIA NIA Enclosed NIA Enclosed N/A

N/A

p . 0 6

Thyroid and Diabetes Management Center NRC Byproduct Material License Application

RADIOACTIVE MATERIAL AND USE

Item 5 Item 6 Byproduct Material Amount Purpose

Material i n 35.300 As needed Radiopharmaceuticals 1 Curie of 1-131 f o r therapy

RADIATION SAFETY PROGRAM RESPONSIBILITY

Item 7.1

Authorized Users Materials and Use

Richard S. Long1ey.M.D.

Item 7.3

Radiation Safety Officer

Richard S. Longley,M.D.

35.300(including 1-131 thyroid

carcinoma therapy)

P.07

Thyrold and Dlabetes Management Center NRC Byproduct Material License Appllcatlon

i PERSONNEL TRAINING PROGRAM

Page 1 of 2 Item 8.1

Personnel

All indivlduals who In the course of employment recelve an occupational dose 'dl1 be instructed In accordance wlth 10 CFR 19.12.

Training Frequency

1. Before assuming duties wlth, or in the vlcinlty of, radloactlve materials.

2. During annual refresher training.

3. Whensver there Is a significant change in duties, ragulations. or in the terms of the

lnstructlon Toplcs

1. Applicable regulations and llcense condltions.

2. Areas where radioactive material is used or stored.

3. PotenHal hazards assaclated wlth radioactive materlal in each area where the

4. Appropriate radiatlon safety procedures.

5. The Ilcensee's in-house work rules.

6. Each indivldual's obligatlon to report unsafe conditions to the Radlatlon Safety

7. Approprlate response to emergenclea or unsafe conditions.

8. The workel's rlght to be Informed of occupatiorral radiation exposure and bioassay

license.

employees wlll work.

Offlcer.

results.

f

Thyroid and Diabetes Management Center NRC Byproduct Material License Appilcetlon

/tern 8.1 (cont)

9. Locations where the llcensee has pasted or made avallable notices, copies of pertinent regulations. and copies of the license and ilcense conditions, a8 required by 10 CFR Part 19.

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

The methods used for this training may be one or more of the following:

Page 2 of 2

a. Lectures b. Review of Written Instructton c. Video-Tape d. WrittenTests

P.09

Thymld and Dlabetes Management Center NRC Bvproduct Material License Application

EQUIPMENT LIST

Item 9.1

D o s e Callbrator Capintec CRC-15R (or equlvalent)

Survey Meter8 Blcron GM (or equivalent) Surveyor 2000 Range (0.01 mWh-2000 mR/h)

Vlctoreen Ion Chamber (or equivalent) 740G Range (1 mRhl000 mWh)

Other Well Counter Uptake Probe Lead Glass Face Shields Leaded Syringe Shlelds Remote Handling Tools Lead Bricks Lead Storage Containera RadlacWash Absorbent Pads

P. 10

Thyroid and Diabetes Management Center NRC Byproduct Materlal Llcense Application f

CALIBRATION OF SURVEY INSTRUMENTS Item 9.2

All survey Instruments wlll be cailbrated and checked in accordance with 10 CFR 35.51 Survey instruments wlll be calibrated by:

1. The manufacturer:

2. Medical Physics Consultants: (NRC License # 21-20153-01)

3. Any authorized user llcensed to perform survey meter callbratlons as a servlce.

P . l l

Thyroid and Diabetes Management Center NRC Byproduct Material License Application i

Item 8.3

Test

Constancy

Linearity

Accuracy

Geometry Dependence

CALIBRATION OF DOSE CALIBRATOR

Page 1 of2

Frequency Tolerance

Daily prior to patient dose assays +I- 10%

+/- 10%

+I- 10%

+I- 10%

lnstallatlon, following repair, and quarterly

lnstallatlon, followlng repair, and annually

Installation and following repalr

CONSTANCY testlng will be performed using a long-lived reference Sourcs (8,s.. Ceslum-137) with actlvlty greater than 50 microcuries. Zero or record the background reading on the appmprtate setting. Assay the source for both the reference 8ourcB settlng and the most commonly used radlopharmaceutical settings. Record the readlngs and compare to the calculated values. The Radlation Safety Mncer will be notlfled and the unit wlII be repaired or replaced If the constancy error exceeds 10 percant.

LINEARITY testing will be performed using a Technellurn-99m source having actkrlty at least as great as the maximum actlvlty admlnlstered to patlents. Testing will be conducted with the decay or the leaded-sleeve method over the entire range of edmlnistered actlvlty.

P.12

Thyroid and Diabetes Management Center NRC Byproduct Materlal License Applicatlon

{rem 9.3 (cont.)

Page 2 of 3

Decay method: Assay the source at approximately 0, 6, 24, 30, 48, etc. hours over the entire range of use (between the highest actlvity admlnlstered to patients and 30 UCi). Record the net actlvltles, tlme, and date. Uslng a measured activlty for reference, which is closest to that which Is commonly admlnlstered to patlents, calculate the expected readlngs and compare to the measured readings. The Radiation Safety Officer must revlew and sign the test document. The Radiation Safety Officer will be notified and the unit will be repaired or replaced or patlent dosage readings wlll be mathematically corrected if the linearity error exceeds 10 percent over the range of activlty.

Sleeve method: The sleeves wlll be calibrated at the tlme of an lnltial reading of a decay-method llnearlty test. Elther the "Callcheck" or "Llnsator" product wlll be used, and the testing procedure will be performed according to the manufacturer's Instructions. The Radiation Safety Officer must review and sign the test document. The Radiation Safety OPflcer wlll be notlfled and the unlt will be repaired or replaced Or patient dosage readlngs wlll be mathematlcally corrected if the llnearlty error exceeds 10 percent over the range of use.

ACCURACY testing will be performed uslng Cesium-137 and Cobalt-57 or Barium-133 reference sources havlng NBS-traceable actlvltles greater than 50 mlcrocurles. The net measured actlvltles wlll be compared to the calculated actlvltles based on radloactive decay. The Radlatlon Safety Officer must review and sign the test document. The Radlatlon Safety Officer will be notified and the untt wlll be repalred or replaced If the accuracy error exceeds I O percent.

GEOMETRY DEPENDENCE testing will be performed uslng a solutlon of Technetlurn- 99m having an activity concentratlon of 1-10 mCVml. If generaton andlor radlopharmaceutical klts are normally used, both of the following tests will be performed:

Unlt dose users will assay 0.5 cc of the solutlon In a 3 cc plastic syringe. The solution in the syringe will then be diluted wlth water and assayed at incremental volumes of 1.0, 1.5, and 2.0 cc. Record all readlngs. Select a standard volume closest to that nOrmally used for injectlona and divide the activity by the other measured actlvlties. If any error exceeds 10 percent, correction factors will be applled to the appropriate volumes and a correction factor chart wit1 be applied to the dose calibrator. The Radiation Safety Offlcer must review and sign the test document. The Radiation Safety Officer Will be notied and the unlt wlll be repaired or replaced or patlent dosage readings will be mathematlcally corrected if the geometry error exceeds 10 percent.

P. 13

(- Thyroid and Dlabetes Management Center NRC Byproduct Materlal Llcense Applicatlon

kern 9.3 (cant)

Page 3 of 3

Generator/klt users will assay 1.0 cc of the solution In a 30 cc glass vial. The solution In the vial wlll then be diluted with water and assayed at incremental volumes of 3, 5, 7, 9, 11, 13, 15, 17, and 19 cc. The assays should take place within 10 mlnutes. Record all readings. Select a standard volume closest to that normally used for mixing kits and dlvlde the activity by the other measured activities. If any error exceeds 10 percent, correctlon factors wlll be applied to the appropriate volumes and a correctlon factor chart wlll be applled to the dose calibrator. The Radiation Safety Offlcer must review and sign the test document. The Radiation Safety OfRcer will be notified and the unit will be repaired or replaced or patlent dosage readings will be mathematically corrected If the geometry error exceeds 10 percent.

P. 14

Thyroid and Dlabetes Management Center NRC Byproduct Material Llcense Application c

PERSONNEL MONITORING PROGRAM Item 9.4

1. The RSO or delegate will promptly review all film, thermoluminescent (TLO), or optically stimulated luminescent (OSL) dosimeter exposure reports to look for workers or groups of workers whose reported exposures are unusual.

2. All indlvlduals who are occupationally exposed to radiation on a regular basls wlll be issued a fllm, TLD, or OSL whole body monitor.

3. All Individuals who handle radioactive material MI a regular basis will be issued a fllrn. TLD. or OSL finger monitor.

4. All lndlvlduals who are occupatlonally exposed to significant radiation levels on an occasional bask, such as nurs6-s carlng for radiopharmaceutical therapy or implant patlents, will be issued a whole body monitor when caring for those patlents.

5. Other lndlvlduals who are exposed to radiation on an occasional basis such as security personnel who deliver packages, secretarlal personnel who work In the nudear rnedklne clink but do not work wlth patlents, and nurses who occaslonally care for patients who have recelved diagnostic dosages will not normally be Issued exposure monltors.

6. All film, n D , and OSL badges wlll be changed on a monthly bask

7. All personnel monitoring devices will be supplied by a vendor who Is accredited by the National Voluntary Laboratory Accredltatlon Program (NVLAP).

P. 16

Thyroid and Dlabetes Management Center NRC Byproduct Materlal Llcense Application c

RADIATION SAFETY OFFICER DELEGATION OF AUTHORITY /tern 10.1

Radiation Safety Offlcer (RSO) delegatlon of authority.

Memo To: All Employees From: Chief Executive Officer Subject: Delegation of Authority

Richard S. Longley, M.D. has been appolnted Radiation Safety Offlcer and Is responslble for ensurlng the safe use of radiation. The Radiation Safety OlYker is responslble for managing the radlatlon safety program; Identifying radiatlon Safety problems; Inltlatlng, recommending, or provlding correctlve actlons; verlfylng lmplementatlon of correctlve actlons; and ensuring compliance with regulations. The Radiation Safety Officer la hereby delegated the authority necessary to meet those responslblllties.

The RadlaUon Safety Offlcer is also responsible for assisting the Radiation Safely Committee in the performance of its dutles and serving as Its secretary.

P.16

<-

c.

Thyrold and Dlabetes Management Center NRC Byproduct Material Llcense Appllcatlon

MAINTAINING OCCUPATIONAL RADIATION EXPOSURE A U R A

Item 10.2 Page 1 of 7

Thls llcense Is for an outpallent clinic and therefore Is not requlred to have a Radlatlon Safety Commlttee. The following statements referring to the Radlatlon Safety Commlttee will actually mean Radlatlon Safety Officer for thls Ilcense. All pertinent rssponslbllltles of the Radlatlon Safety Commlttee wlll be met by the RadlatJon Safety OCllcer, wlth the assistance of the radlological physics consultants.

1. Management Commltment

a. We, the management of thls rnedlcal fadllty, are committed to the program described hereln for keeping lndlvldual and collective doses as low as Is reasonably achievable (ALARA), In accord with thls mmmltment, we hereby descrlbe an admlnistrative organization for radiatlon safety and wlll develop the necessary wrltten pollcy, procedures, and instructions to foster the A U R A concept within our facllity. The organlzatlon wlll Include a Radiation Safety Committee (RSC) and a Radlatlon Safety Officer (RSO).

b. We wlll perform a formal annual revlew of the radiation safety program, Including A U R A conslderatlons. Thls wlll Include reviews of operating procedures and past dose records, inspections, etc., and consultatlons wlth the radlatlon safety staff or outaMe consultants.

c. Modlflcatlons to operating and malntenance procedures and to equipment and facllltles will be made K they will reduce exposures unless the cost, In ouf judgment, is considered to be unjustified. We will be able to demonstrate, If necessary, that improvements have been sought, that modifications have been consldered, and that they 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 addltlon to maintaining doses to Individuals as far below the llmlts as Is reasonably achlevable, the sum of the doses received by all exposed individuals will also be maintained at the lowest practicable level. It would not be desirable, for example, to hold the highest doses to individuals to some fractlon of the applicable llmlt If thls Involved exposing addltlonal people and slgnlficantly increasing the sum of radiation doses received by all involved indlvlduals.

P.17

I--

\...

Thyrold and Diabetes Management Canter NRC Byproduct Material License Applicatlon

ltem 70.2 (cont.) Page 2 of 7

2. Radiation Safety Committee

a. Review of Proposed Users and Uses

(1) The RSC wlll thoroughly revlew the qualifications of each appllcant wlth respect to the types and quantltlas of materials and methods of use for which application has been made to ensure that the applicant will be able to take appropriate measures to maintain exposure ALARA.

(2) When considering a new use of byproduct material, the RSC will revlew the efforts of the applicant to malntaln exposures ALARA.

(3) The RSC will ensure that the usem justify their procedures and that individual and collective doses wlll be ALARA.

b. Delegation of Authority

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

(2) The RSC will support the RSO when It Is necessary for the RSO to assart authority. If the RSC has overruled the RSO, it will record the bad8 for Its actlons In the rnlnutes of the quarterly meetlng.

c. Review of ALARA Program

(1) The RSC wlll encourage all users to revlew current procedures and develop new procedures as appropriate to implement the ALARA concept.

(2) The RSC will perfarm a quarterly review of occupational radiation exposure wlth partlcular attention to Instances in whlch the investlgatlonal levels In Tabla I are exceeded. The principal purpose of this revlew Is to assess trends in occupational exposure as an Index of the ALARA program quality and to declde If actlon Is warranted when investigational levels are exceeded.

Thyrold and Dlabetes Management Center NRC BvDroduct Material License Application /

Item 10.2 (cont.) Page 3 of 7

Table I: Investlgatlonal Levels Level I Level II

Body Part Exposed (mrems per calendar quarter)

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

2. Lensofeye 375 1 I25

3. Hands and forearms; feet and 1250 3750 ankles

r

4. Skin of the whole body 1250 3750

(3) The RSC wlII evaluate our Institutlon's overall efforts for maintaining doses AIARA on an annual basis. This review will include the efforts of the RSO, euthorized users, and workers as well as those of management.

3. Radiatlon Sahty Omcer

a. Annual and Quarterly Revlew

(1) The RSO wfll perfarm or cause to be perfonned an annual revlew of the radlatton safety program for adherence to A U R A concepts. Revlew of speclflc methods of use may be conducted on a more frequent basls.

(2) Quarterly review of occupational exposures. The RSO wlll review or cause to be revlewed at least quarterly the external radiation doses of authorlzed users and workers to determine that thelr doses are ALARA In accordance wfth the provisions of Sectlon 6 of this program and will prepare a summary report far the RSC.

(3) Quarterly revlew of records of radiation surveys. The RSO wlll review or cause to be revlewed radiation surveys In unrestrloted and restricted areas to determlne that dose rates and amounts of contamlnetlon were at ALARA levels during the previous quarter and wlll prepare a summary report for the RSC.

Annual review of the radiation s&ty program.

P. 1 9

Thyroid and Dlabetes Management Center NRC Byproduct Material License Application


b. Education Responsibllitlos for tho ALARA Program

(1) The RSO wlll schedule brleflngs and educational sessions to Inform worken of ALARA program efforts.

(2) The RSO will ensure that authorlzed users, workers, and ancillary personnel who may be exposed to radlatlon wlll be Instructed In the ALARA phllosophy and Informed that management, the RSC, and the RSO are committed to implementing the AURA concept.

c. Cooperative Efforts for Development of ALARA Procedures

Radlation worker8 will be glven opportunities to participate In formulating the procedures that they wlll be requlred to follow.

(I) The RSO wlll be In close contact with all users and workers In order to develop ALARA procedures for worklng wlth radloactlve materials.

(2) The RSO wlll establish or cause to be established procedures for receivlng and evaluatlng the suggestlons of individual workers for improving health physlca practlces and will encourage the use of those procedures.

d. Reviewing instances of Deviation from Oood ALARA Practices

(1) The RSO wlll lnvestlgate all known instances of devlatlon from good A M practices and, If possible, wlll determine the causes. When the cause is known, the RSO will implement changes In the program to maintain doses ALARA.

4. Authorized Users

a. New Methodo of Use Involving Potontlal Radiatlon Doses

(1) the plannlng stage before uslng radloactlve materials for new uses.

(2) meterials to ensure that doses will be kept ALARA.

The authorlzed user will consult wlth the RSO and/or RSC durlng

The authorized user will review each planned use of radioactive

P . 2 0

Thyrold and Diabetes Management Center NRC Byproduct Material License Appllcatlon

Item 10.2 (cant.) Page 5 of 7

b. Authorlred Uoer's Responslbittty to Supervised Jndlvlduals

(1) The authorized user will explain the ALARA concept and the need to maintain exposures ALARA to all supervised individuals.

(2) The authorized user wlll ensure that supervlsed lndlvlduals who are subJect to occupatlmal radiation exposure are trained and educated In good health physlcs practices 3nd In malntalnlng exposures ALARA.

5. lndhrlduals Who Recelve Occupstlonal Radlatlon Doses

a. Workers wlll be Instructed in the ALARA concept and Its relatlonship to work

b. Workers wIII be Instructed in recoumes available if they feel that A U R A in not

Establishment of Investlgatlonal levels In Order to Monitor lndlvidual Occupatlonal External Radlatlan Doses

This faclllty hereby establlshes Investigational levels for occupational external radlatlon doses which, when exceeded wlll Initiate review or lnvestlgatlon by the RSC andlor RSO. The investlgatkmal levels that we have adopted are llsted In Table 1. These levels apply to the expasure of lndlvklual workers.

The RSO will revlew and record on form NRC-5, "Current Occupational External Radlation Exposures," or an equlvalent form (e.g., dosimeter processor's report) results of personnel monitoring not less than once In any calendar quarter as required by 10 CFR Part 20. The following actions wlll be taken at the investigatlonal levels as stated in Table 1:

a. Pernonnel dose less than lnveotlgatlonal Level 1.

Except when deemed appropriate by the RSO, no further action wlll be taken In those cases where an Indlvidual's dose is less than Table 1 values for the lnvestlgetional Level I.

procedures and work condltions.

being promoted on the job.

0.

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Thyroid and Diabetes Management Center NRC Byproduct Material Llcense Application

item 10.2 (cont.) Page 6 of 7

b. Personnel dose equal to or greater than lnvestlgatlonal Level I but less

The RSO wilt review the dose of each individual whose quarterly dose equals or exceeds Investigational Level I and wlll report the results of the reviews at the flrst RSC meetlng fOllOWlng the quarter when the dose was rerorded. If the dose does not equal or exceed Investigational Level II, no action related specifically to the exposure is required u n l m deemed appropriate by the Committee. The Committee will, however, revlew each such dose in comparison with those of others performing similar tasks as an Index of ALARA program quallty and will recard the revlew In the Committee mlnutes.

c. Personnel dose equal to or greater than lnvestlgatlonsl Level II.

The RSO will lnvestlgate In a timely manner the causes of all personnel doses equaling or exceeding investigational Level I I and, if warranted, will take action. A report of the investigation, any actbns taken, and a copy of the indivldual's NRC Form-5 or Its equlvalent wlll be presented to the RSC at Its flrst meetlng foilowlng compietlon of the Investlgatlon. The details of these reports will be Included in the RSC minutes.

d. Rosotabllshment of lnvestlgatlonal Levels to levels above those listed In Table 1.

In cases where a worker or group of workers' doses need to exceed an Investigational level, a new, hlgher Investlgatlonal level maybe establlshed fw that indivldual or group on the bask that it is consistent with good A U R A practices. Justification for new investlgatianal levels wlll be documented. The RSC wlll review the justiflcaUon for and must approve or disapprove all revisions of lnvestlgatlonal levels.

than lnvsstlgatlonal Level II.

P.22

Thyrdd and Diabetes Management Center NRC Byproduct Materlal Llcense Appllcation F- -

Item 10.2 (cant.)

7. Signature of Certifying Offlclal

I hereby certii that this Institution has implemented the ALARA Program set forul above.

Page 7 of 7

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(-

Thyroid and Diebetes Management Center NRC Bvomduct Materlal Llcense Appllcetion

PROCEDURE FOR LEAK-TESTING SEALED SOURCES

Item 10.3

1. Medical Physics Consultants, Inc. (NRC License No. 21-20153-01), or anyone llcensed by the NRC to perform leak testing B5 a service. Sources will be leak tested on a bi-annual basis that is not to exceed 6 months.

P.24

Thyrold and Dlabetes Management Center NRC Byproduct Material License Application

RULES FOR THE SAFE USE OF RADIOPHARMACEUTICALS

kern f0.4 Page 1 of 2

1. Wear laboratory coats or other protective clothing at all times in areas where

2. Wear dlsposable gloves at all Emes while handllng radioactive materials.

3. Elther after each procedure or before leavlng the area, monitor your hands and clothlng for contamlnatlon In a low background area.

4. Use syringe shields for routine preparation of patient dosages and administration to patients, except in those circumstances In whlch thelr use Is contralndhted. In these exceptlonal cases, consider the use of other protectlve methods such as remote dellvery of the dose.

5. Do not eat, drink, smoke, or apply cbsmetlcs In any area where radloactive material is used or stwed.

6. Do not store food, drink, or personal effects in areas where radioactive material is used or stored.

7. Wear personnel monitoring devices (as prescribed by the RSO) at all tlmes while In areas where radioactive materials are used or stored. Store personnel mOnltOrlng devices at the faclllty In a deslgnated lowbackground area.

8. Wear a flnger exposure monltor during the elution of generators; during the preparation, assay, and Injection of radiopharmaceutids, and when holding patients during procedures.

9. Dispose of radloactlve waste only In designated, labeled, and properly shielded receptacles.

I O . Wipe-test byproduct material storage, preparation, and administratlon areas weekly for contamlnatlon. If necessary, decontaminate or secure the area for contamlnatlon.

11. Wlth a radiation detectlon survey meter, survey the generator storage, kit preparatlon, and injection areas dally for contamination. If necessary, decontamhate or secure the area for decay as appropriate.

radioactive materials am used.

P . 2 6

Thyroid and Diabetes Management Center NRC Byproduct Material License Application i Item 10.4 (cont.)

12. Confine radioactive solutions In shlelded contalnen that are clearly labeled with the Isotope, compound name, and the date and tlme of receipt or preparation. Syringes and/or syringe shields shall be labeled with the radiopharmaceutical name or abbreviatlon contalned wlthln, type of study, or patlent’s name.

13. Assay each patlent dose In the dose calibrator before administration. Do not use a dose If It dlffera from the prescribed dose by more than ten percent, except PreSCriptlOnfi of less than 10 uCi. Check the patlent’s name and I.D. number and the prescribed radlonuclide, chemical form, and dosage before admlnistering.

Page 2 of 2

14. Always keep radloactlve materials in shielded locations or mntalners.

15. When practlcal, use a cart br wheelchair to move flood sources, syringes, waste. and other radloactlve materlel.

16. It 18 prohlblted to pipette by mouth,

P.26

Thyroid and Diabetes Management Center Wr QvDroduct Material License Application

i EMERGENCYPROCEDURES

Item 13.5 Page I of2

Mlnor 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 dlsposable glove8 and remote handling tools. Carefully fold the absorbent paper wim the clean side out and insert in a plastlc bag for transfer to a radioactive Waste container. Also place the contaminated gloves and any other contaminated disposable material in the bag.

4. SURVEY Survey the area with B low-range. GM survey meter. Check the area around the splll, hands, clothing, and shoes for contamination.

5. REPORT: RepOR the incident to the RSO who wlll supervise the cleanup of the splll and complete the Radioactive Spill Report and the Radioactive Spill Contamination Survey. The RSO may delegate the actual clean-up and survey performance to a trained technologist. However, the RSO will retaln the ultimate responsibility to ensure that the Report and Survey are completed properly.

MaJor Spills

1. CLEAR THE AREA: NatHy all persons not involved in the splll to vacate the room.

2. PREVENT THE SPREAD: Cover the splll wlth absorbent paper, but do not attempt to clean i t up. Confine the movement of all personnel potentially contaminated to prevent the spread.

3. SHIELD THE SOURCE: Thls should be done only I it can be done without further contamination or a signlflcant increase in radiatlon exposure.

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

5. NOTIFY: Notm the RSO immediately.

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c Thyrald and Dlabetes Management Center NRC Byproduct Material License Appllcation


8. PERSONNEL DECONTAMINATION: Decontaminate personnel by removing contaminated clothing and flushing the contaminated skln wlth lukewarm water and then washlng with rnlld soap. If contamination remalns, induce perspiration by coverlng the area with plastic. Then wash the affected area again to remove any contamlnatlon released by the perspiration.

7. REPORT: The RSO will supervlse the cleanup of the splll and complete the Radloactlve Spill Report and the Radioactive Spill Contamination Survey. The RSO may delegate the actual clean-up and survey performance to a tralned technologlst. However, the RSO wlll retain the ultlmate responslbllity to see that the report and the survey are completed properly.

P.28

<- Thyroid and Diabetes Management Center NRC Byproduct Materlal Llcense Application

PACKAGE ORDER AND RECEIPT PROCEDURES

/fern IO. 6

1. The Radlatlon Safety Officer (RSO) or a designee must authorize each order for redloactlve materlals and ensure that the requested materials and quantltles are authorized by the license for use by the requestlng authorlzed user and that possession limits are not exceeded.

2. The RSO will establlsh and malntaln a system for ordering and receiving radioactive materlai. The system must contain the following information:

a. For routlnely used materials

(I) Written records that IdenUfy the authorized user or department, isotope, chemical form, activity, supplier will be made.

(2) The above records will be checked to confirm thet material received was ordered through proper channels.

b. For occaslonally used materials

(1) The authorlzed user who wlll perform the procedure will make a written request that lndlcates the Isotope, radiophannaceutlcal, activity, and suppller.

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

3. For deliveries during normal worklng hours, packages are received at the Nuclear Medicine department.

4. If off duty deliveries are necessary, the canier has been given a key to the Hot Lab. The carrier will then place the package within the Nudear Mediclne Hot Lab and re- lock the door of the Nuclear D e p a ~ m t and the Hot Lab.

P. 29

Thyroid and Dlabetes Management Center NRC Bvproduct Material Llcense Application

PROCEDURE FOR OPENING PACKAGES CONTAINING RADIOACTIVE MATERIAL

ttem 70.7

1. Put on gloves to prevent hand contamlnation.

2. Vlsually Inspect the package for any slgn of damage (e.g., wet or crushed). If damage Is noted, stop and notify the RSO.

3. Measure the exposure rate from the package at 1 meter and at the package surface. If the rate is hlgher than expected, stop and notify the RSO. The surface dose rate should not exceed 200 mllllrern per hour. Packages with the “Whlte I“ labels should be less then 0.5 mlllirern per hour at the package surface.

4. Wipe the external surface of the source container and analyze the sample for actlvlty In (dpm’s). If the value Is above the established trigger level, and there is contamlnation, notify the RSO.

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

a. Remove the packlng sllp. b. Open the outer package following the supplier’s Instructions, If available. c. Open the inner package and verify that the contents agree with the packing

d. Check the lntegrlty of the final sourcu container. Look for broken seals or vials, loss of Ilquid, condensation, or discoloration of the packing material.

e. If anythlng unusual is noticed. stop and notlfy the RSO.

sllp.

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

7. Monltor the packing material and the empty packages for contamination with a GM survey meter before dlscarding. If contaminated, treat as radioactive waste. If not wntamlnated, deface all radiation labels before discarding.

8. Record the receipt and all readings taken.

9. For packages recalved under a general license In 31.1 1, follow the steps listed

a. Visually inspect the package for damage. If damage Is noted. stop and notify

b. V0My that material received Is the material ordered.

below for each package.

the RSO.

P.30

Thyroid and Diabetes Management Center NRC BYDmdUd Material License Applicatlon

i UNIT DOSE RECORDS

lfem 10.8

Unlt Dose Records shall contaln:

I. Technlcal Data

a. Radionudide b. Chemlcal form or abbreviation c. Date of recelpt, adrnlnistratlon or disposal d. Activity as recorded on the packing slip e. Supplier f. Lot or control number

2. Administrative Data

a. Tlme and date of admlnlstratlon or disposal b. Measured activity e. Patient name and ID number d. Method of dlsposal e. lnfflals of person recording the information f. Prescribed Dosage

MULTIDOSE VIAL RECORDS

Item 10.9

Multidom Vlal Records shall contain:

I. Technical Data

a. Radlonucllde b. Chemical form or abbrevlatlon c. Date of preparation d. Date, time, and adlvlty of initial assay e. Supplier of kit manufacturer

2. Administrative Data

a. Date and tlme dosage was drawn b. Prescribed dbsage c. Calculated volume needed for prescrlbed dose d. Measured activity e. Patlent name and ID number f. Method of disposal and date g. lnitlals of person recordlng Information

P.31

i Thyroki and Dlabetes Management Center NRC Byproduct Material License Appllcatlon

BYPRODUCT MATERIAL USE Ifern 10.10

Molybdenum Concentration Records shall contain:

a. Date the generator was recelved b. Date and time of elution c. Measured Me99 acHvlty In microcuries d. Measured Tc-99m activity In mllllcuries e. Ratlo of the total Ma-99 rnlcrocurles per millicurie of Tc-ggrn and

documentation that the retlo Is less than specifled in 10 CFR 35 f . Initials of the person who made the record

c

c

P . 3 2

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,

Thyroid and Diabetes Management Center NRC Bvprodud Material License Application

AREA SURVEY PROCEDURES

Page I of 2 Ifem 10.12

Surveys for contamination and ambient exposure rates will be performed in accordance with 10 CFR 35.

1. All areas where radiopharmaceuticals are eluted, prepared, and administered will be surveyed at the end of each day of use for ambient radiation exposure rates and weekly for removable contamination. Special care will be taken to remove all paraphernalia from patient's rooms where diagnostic administrations are occasionally made; and these rooms will not be surveyed.

2. All areas where radioactive materials are stored will be surveyed weekly for ambient radiation exposure rates and for removable Contamination.

3. Laboratory areas where each process involves less than 200 uCi of by-product materials will be surveyed monthly for ambient radiation exposure rates and removable contamination.

4. Surveys for ambient exposure rates will be performed with a radiation detection survey instrument able to detect as low as 0.1 mWh.

5. Surveys for removable contamination will consist of a series of wipes, which will be assayed using a procedure sufficiently sensitive to detect 2000 dpm.

6. The trigger levels for exposure rate surveys will be established by the Radiation Safety Officer in compliance with 10 CFR 35.70(d). These trigger levels wiil ensure compliance with 10 CFR 20 and may vary from 0.2 - 2.0 mFUhr. depending on location 8, purpose.

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

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

P . 3 3


Item IO. 12 (coni.) Page 2 of 2

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

a. Location, date, 2nd 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 drawlng. f. Corrective actions taken in case of contamination or excessive exposure

rates and reduced contamination levels after corrective action.

10. The RSO or their designate will review the survey results on a quarterly basts for conformance to certain action levels.

11. The method for determining the efficiency factor of each counting instrument used to detect contamination for wipe testing is as follows:

A= Calculated source activity of sample isotope in dpm

B= Measured source counts of sample isotope in cpm

C= Measured background counts in cpm

D= 6-C (Net Counts in cprn)

Efficiency Factor = C-1 Net counts in cprn (Dl

Wipe sample in dprn = Net counts of wipe sample x Efficiency factor

12. The RSO will be notified of all positive wipe test and ambient survey results.

P . 3 4

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AIR CONCENTRATION CONTROL

WORKER DOSE FROM NOBLE GASES

Item IO. 13.1

We will not use radioactive gases at this facility.

WORKER DOSE FROM AEROSOLS Item 70.73.2

We will not use aerosols at this facility.

PUBLIC DOSE FROM AIRBORNE EFFLUENT

Item 10.13.3

We will not directly vent spent aerosols and gases to the atmosphere and therefore no effluent estimation is necessary.

SPILLED GAS CLEARANCE TIME

Item 10.13.4

We Will not be using radioactive gases at this facility, therefore it is unnecessary to calculate a spilled gas clearance time.

P . 3 5


RADIOPHARMACEUTICAL THERAPY

Item IO. 14

Our department intends to use Iodine-I 31 for outoatient radiopharmaceutical therapy in accordance with 10 CFR 35.75.

P.36


Itern 11.1 WASTE DISPOSAL

Page I of 2

Liquids and Gases

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

1. Disposal to the sanitary sewer system will be made in accordance with 10 CFR 20. A record will be kept of the following: date, radionuclide, estimated activity released, and place where material was released.

2. Permissible concentrations in effluents will be kept within the limits enumerated in 20 CFR 20. A record will be kept of the date, radionuclide, estimated activity released, estimated concentration, and vent site at which the material was released.

~

Decay in Storage

1. Only material wlth a physical half-life of less than 65 days may be decayed in storage at the facility.

2. Each container will be tagged to include:

a. the date sealed or set into storage b. the longest-lived isotope in the container c. 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 monitored as follOwS:

a. Low-range GM survey meter will be checked for proper operation. b. 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. e. Only those containers which cannot be distlnguished from background levels

will be disposed of after all radioactive labels have been defaced. f. The date on which the container was placed in storage will be recorded. g. The date of disposal will be recorded. h. The type of material will be recorded.

P.37

Thyroid and Diabetes Management Center NRC Byproduct Material License Application r-

Item 7 7.1 (cont.) Page 2 of 2

5. Mo-99TTc-99m generators wlll be held for at least 60 days before being dismantled. When dismantling generators, a low-range GM survey meter will be kept at the work area. The oldest generator will be dismantled first, working forward chronological 1. Each individual column will be held in contact with a low-level survey instrument in a low background (less than 0.05 mR/h) area. The generator dete and disposal date will be logged In the disposal records. Radiation labels will be removed or defaced on the generator shield. Generators may also be returned to the manufacturer for disposal. Manufacturer's instructions will be followed.

Unit Dose Waste

If a unlt dose pharmacy is used, the materials supplied by them (e.g., syringes, needles, etc.) may be returned to the unlt dose pharmacy In the original shipping container. Pertinent DOT regulations will be followed as specified by the unit dose pharmacy.

.

P . 3 8


Item 72.1

RADIOPHARMACEUTICAL QUALITY MANAGEMENT PROGRAM

Page 1 of 5

1. 0biecti.ve

"to provide hlgh confidence that byproduct material will be administered as directed by the authorized user."

2. ftcsoonsibilitv, Authority,,.a Review

The responsibility and authority to establish and implement the Quality Management (QM) Program shall be given to the Chief Nuclear Medicine Technologist.

3. instruction

All individuals responsible for prescribing, preparing, or administering dosages which require written directives as outlined in this program wiii be instructed in the requirements of the Quality Management Program on an annual basis.

4. Elements for Medical Use - - Radiopharmaceutical Therapies and.Nal 1.125 or Nab131 >30 uCi

A. Prior to administration, a written directive will be prepared for:

i. any therapeutic administration of a radiopharmaceutical and ii.any adminlstration of Nal l-125 or Na-131 greater than 30 uci.

With regard to diagnostic and therapeutic radiopharmaceuticals "A written directive means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, containing the following information:

1. Patient name. 2. Patient identification number, if available.

4. Dosage. 5. Route of administration, 6. The type of procedure desired.

3. Radiopharmaceutical. \

P . 3 9

r

r

.



Revisions to written directives may be made for any diagnostic or therapeutic procedure provided that the revlslon is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage. No oral revisions to a written directive will be considered acceptable. All oral (written directive) will not be considerable acceptable

8 . Prior to administration, the patient's identity is verified by more than one method as the individual named in the written directive by the person administering the radiopharmaceutical.

1. The patient shall be called by name. 2. The patient shall be asked to spell their name. 3. The patient shall be asked to state their birth date. 4. The patient shall be asked to state their Social Security Number. 5. The patient shall be asked for some identification such as driver's license. 6. The in-patient's wristband shall be checked.

If the information obtained from both of any two of these methods does not correspond to the information on the written directive, the radiopharmaceutical shall not be administered until conclusive verification that this procedure Is intended for this patient is obtained.

C. Each administration is in accordance with the written directive

The technologist shall read the written directive before preparing or administering the radiopharmaceutical, If any portion of the wrltten dlrective is unclear to the technologist, they shall contact an authorized user for clarification.

The radiopharmaceutical shall not be administered until the intent of the written directive is thoroughly understood by the technologist. If the technologist preparing the dose is different from the technologist administering the dose, both technologists shall read and understand the written directive.

The technologist shall verify that the specific details of the administration (radiopharmaceutical, dosage, and route of adminlstratlon) are in accordance with the written directive. The actual dose calibrator assay shall be verified with the dosage listed on the written directive.

P . 4 0



After administration of a radiopharmaceutical, the individual administering the dosage shall make a written record that documents the administered dosage in reviewable form, date the written record, and sign or initial the written record.

D. Retention of written directives

Each written directive and a record of each administered radiophamaceutical dosage shall be retained for three years after the date of administration.

E. Any unintended deviation from the written directive is identified and

~

~

I

evaluated, and appropriate action is taken.

Upon identification of an unintended deviation, an investigation of the incident shall be made. The cause of the incident shall be determined and, if appropriate, corrective procedures will be implemented. Documenting and reporting of the unintended deviation shall be in accordance with the reporting rules of Part 35.

F. Recordable Events

All recordable events shall be evaluated within thirty (30) days after discovery. A recordable event shall be responded to by: (1) assembling the relevant facts including the cause; (2) identifying what, if any, corrective action is required to prevent recurrence; and (3) retaining a record, in a reviewable form, for three years, of the relevant facts and what corrective action was taken.

5. Annual Review

The review shall determine the effectiveness of the QM program. Areas identified as inadequate shall be modified to meet the objectives of 35.32(a).

Records of each review, including the evaluations and findings in a reviewable form for three years will be retained for three years.

Frequency: A review of the quality management program shall be conducted at twelve (12) month intervals.

P.41

r

...


/tern 72.7 (cont.) Page 4 of 5

Responsibility: The review shall be conducted by the consulting medical physicist. Management shall be briefed in writing of the findings.

Sampling: If patient administrations exceed 100, 20% of these will be used for the review. If patient administrations are less than 100, all of these will be used for the review.

All misadministrations and recordable events previously identified will be included in the annual review.

If misadministrations are identified during the course of the annual review, the sample size will be increased to include all procedures of the type involved in the misadministration.

If recordable events are identified during the course of the annual review, the sample size will be increased to include all procedures of the type involved in the recordable event.

Scope: The review shall evaluate the following items.

1. The compliance rate of having written directives prior to administration of a radiopharmaceutical or radiation in those cases where written directives are required.

2. The content of the wrltten directive is as required.

3. The instruction of the supervised individual(s) in the licensee's written quality management program and requirement of following the authorized user's Instructions.

4. The methods of verifying the patient's identity by more than one method is performed as stated In the QM program.

5. The compliance rate of verifying the patient's identity by more than one method.

6. Radiopharmaceutical or radiation administrations are in accordance with the written directives.

P.42

Thyroid and Diabetes Management Center NRC Byproduct Material License Application c ltem 12. I (cont.) Page 5 of 5

I

c

7. The compliance of the staff in identifying, evaluating, and taking appropriate corrective actions for unintended deviations from the written directive.

~

i ~

8. The compliance with the requirement to respond to each recordable event.

9. The compliance with the requirements to notify and report a misadministration.

10. The compliance with the requirements to keep the appropriate records, including:

the annual reviews the written directives the radiopharmaceutical dosages the recordable events the misadministrations

6. Revislons to the program

I f the program is revised, the revisions will be submitted to the NRC within 30 days after the revision has been made.

P . 4 3


In Reference to 10 CFR 20.7406

1. We will minimize contamination of our facility and the environment by performing daily exposure rate surveys and weekly wipe tests to identify areas of contamination. Contaminated areas will be immediately decontaminated.

2. All radioactive materials used at this facility have half-lives less than 65 days, therefore ail radioactive materials will be decayed on site. If we terminate our license, all radioactive waste that has not fully decayed In storage will be transferred to a licensed disposal facility.

3. Upon termination of our license, we will perform a closeout survey of all areas authorized for radioactive use. The closeoul survey will consist of surveys with a GM meter to detect ambient exposure rates and wipe tests to determine if removable contamination is present.

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