San Patricio MRI & CT Center, Amendment Request

NRC FORM 313 US NUCLEAR REGULATORY COMMISSION

rs

formation nd ollection onduct ollection

PPROVED BY OMS NO 3150middot0120 EXPIRES 31312012

(3-2009) 10 CfR 30 32 33 Estimated burden per response to comply with this mandatory collection request 43 34 35 36 39 and 40 Submittal of the application is necessary to determine that the applicant is

ed and that adequate procedures exist to protect the public health and safety comments regarding burden estimate to the Records and FOIAIPrivac1f Sienices

(Tmiddot5middotF53) US Nuclear Regulatory Commission Washington DC 20555middot0001APPLICATION FOR MATERIAL LICENSE by internet e-mail to infocollectsresourcenrcgov and to the Desk Officer Office 0

and Regulatory Affairs NEOB- 10202 (3150middot0120) Office of Managemen Budget Washington DC 20503 If a means used to impose an informatio

does not display a currently valid OMB control number NRC may no or sponsor and a person is not required to respond to the informatio

i-1N=S=TR=U7CC=T=ION=S-S=E=E=-=T-H=E-A=P=PR=-O=P=R=I~AT=E~LI=C=E-NS=E=-=-A=PP=LICC7A-=T=ION-G~U-I=D=E=FO=R-=D-=E=TA7I1_=E=D-INS=T=R=U=C=T=1O=N=S~F=O-R-C=OM=P=L-E==T-IN--G-A--P=P-L-CIC-A-T=IO=N--~shySEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELcW---------10

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH

OFFICE OF FEDERAL amp SATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS US NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555-0001

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS

IF YOU ARE LOCATED IN

ALABAMA CONNECTICUT DELAWARE DISTRICT OF COLUMBIA FLORIDA GEORGIA KENTUCKY MAINE MARYLAND MASSACHUSEDS NEW HAMPSHIRE NEW JERSEY NEW YORK NORTH CAROLINA PENNSYLVANIA PUERTO RICO RHODE ISLAND SOUTH CAROLINA TENNESSEE VERMONT VIRGINIA VIRGIN ISLANDS OR WEST VIRGINIA SEND APPLICATIONS TO

LICENSING ASSISTANCE TEAM DIVISION OF NUCLEAR MATERIALS SAFETY US NUCLEAR REGULATORY COMMISSION REGION I 475 ALLENDALE ROAD KING OF PRUSSIA PA 19406-1415

IF YOU ARE LOCATED IN

ILLINOIS INDIANA IOWA MICHIGAN MINNESOTA MISSOURI OHIO OR WISCONSIN SEND APPLICATIONS TO

MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION REGION III 2443 WARRENVILLE ROAD SUITE 210 LISLE IL 60532-4352

ALASKA ARIZONA ARKANSAS CALIFORNIA COLORADO HAWAII IDAHO KANSAS LOUISIANA MISSISSIPPI MONTANA NEBRASKA NEVADA NEW MEXICO NORTH DAKOTA OKLAHOMA OREGON PACIFIC TRUST TERRITORIES SOUTH DAKOTA TIEXAS UTAH WASHINGTON OR WYOMING SEND APPLICATIONS TO f) r (

ARLINGTON TX 76011-4125

MATERIAL IN STATES SUBJECT TO US NUCLEAR REGULATORY COMMISSION JURISDICTIONS i1 THIS IS AN APPLICATION FOR (Check appropriate item)

0

NUCLEAR MATERIALS LICENSING BRANCH 0 US NUCLEAR REGULATORY COMMISSION REGION IV 612 E LAMAR BOULEVARD SUITE 400

o7gt031 ))( PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE US NUCLE~R REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED

2 NAME AND MAILiNG ADDRESS OF APPLICANT (Include Zip code)

A NEW LICENSE Dr Carlos Jimenez Marchan 171 San Patricio MRI amp CT Center ILJ B AMENDMENT TO LICENSE NUMBER 52-31166-01 280 Marginal Kennedyo c RENEWAL OF LICENSE NUMBER Guaynabo PR 00968 ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED 14 NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION

San Patricio MEDFLIX I Dr Carlos Jimenez Marchan Nuclear Medicine PhYSician and the Radiation

280 Marginal Kennedy Control Program Director

Guaynabo PR 00968

TELEPHONE NUMBER rSan Patricio MEDFLIX (787) 607-3666

Avenida J F Kennedy Marginal Buchanan km 50

Carretera Estatal PR-2 Barrio Pueblo Viejo

Guaynabo Puerto Rico 00968

TYP~EANDN OF=INFORMA~TIONTO =BE IS D=ESCRIBE=D GU=-=--IDE- shySC=OPE PROV=IDED APPLlCA=TIONIN THE=LICENSE~SUBMITITEMS THROUGH 11 ON 812 X 11 PAPER ==THE 5RAbIOACTIVE ~ATERIAL 6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WilL BE USED

Ia Element and mass number b chemical andor physical form and c maximum amount which will be possessed at anyone time Same

Same

I7 INDIVIDUAL(Sj RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS TRAINING EXPERIENCE

Same Same 19 FACILITIES AND EQUIPMENT 10 RADIATION SAFETY PROGRAM

I Same Same 111 WASTE MANAGEMENT 12 LICENSEE FEES (See 10 CFR 170 and Section 17031) Same

Same T

i FEE CATEGORY 7C

I 13 CERTIFICATION (Must be completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING

UPON THE APPLICANT

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT NAMED IN ITEM 2 CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 CODE OF FEDERAL REGULATIONS PARTS 3D 32 33 34 35 36 39 AND 40 AND THAT ALL INIORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF

WARNING 18 USC SECTION 1001 ACT OF JUNE 25 194862 STAT 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ~Y

SIGNATURE DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MADER WITHIN ITS JURISDICTION

CERTIFYING OFFICER - TYPEDPRINTED NAME AND TITLE

i Carlos Jimenez Marchan MD II ~ ~~~~~==~~~~~~~~~~~-----------------~ TYPE OF FEE FEE LOG FEE CATEGORY ~MOUNT RECEIVED

I APPROVEDBvy~L---~~L-------~---L--------~--~--t~~~-----+--------------~--------~~~----------------------~

NRC FORM 313 (3-2009) PRINTED ON RECYCLED PAPER

-r1~~1 shyNMSSlRGN1 MXratlALS()02

I

SAN PATRICIO

MEDFLIX E DLAGN6STICO rvlAs

December 15 2011

Licensing Assistance Team Division of Nuclear Materials Safety US Nuclear Regulatory Commission Region I 475 Allendale Road King of Prussia PA 19406-1415

ltgt Carlos Jimenez Marchan MD W

NSan Patricio MRI amp CT Center 1508 Roosevelt Avenue Suite 103 San Juan PR 00920

SAN PATRICIO MRI amp CT CENTER REQUEST FOR AMENDMENT TO LICENSE NUMBER 52-31166-01

Please amend the NRC license 52-31166-01 of the San Patricio MRI amp CT Center Facility as follows

Amendment 1

Please add to this license the 10 CFR Part 35300 that applies for the use of unsealed byproduct material for which a written directive is required We will be using exclusively lodine-131 for therapies permitted by 10 CFR 35300 when approved by NRC This will be limited to outpatients who may be released in accordance with the requirements in 10 CFR 3575 Also documents regarding the iodine -131 treatment will be written and available

The name of the AU for part 1 0 CFR 35300 is

bull Dr Carlos E Jimenez Marchan Nuclear Medicine Physician and the Radiation Control Program Director for this facility

bull License 11046 from Commonwealth of Puerto Rico Department of Health of Puerto Rico Board of Medical Examiners

bull Previous license number on which the physician was specifically named as an AU 11810-02 for Parts 35100 200 and 300

280 Marginal Kennedy Guaynabo PR 00968 -Tel 787 620 5757 - Fax 787 620 5761 -wwwsanpatriciomedflixcom

SAN PATRICIO

MEDFLIX

Amendment 2

We would also like to include Dr Roberto A Annexy Marquez [Contact number is [787) 922-4895) as an AU for parts

bull Part 35100 for the use of unsealed byproduct material for uptake dilution and excretion studies for which a written directive is not required

bull Part 35200 for the use of unsealed byproduct material for imaging and localization studies

bull Part 35300 for the use of unsealed byproduct material for which a written directive is required

Enclosed you will find two copies of the following information for the amendment process and

approval U~middot ~fAnOstc dOlCterS fkat 1 The Application for Material License Wl( ( JU 9ptlHs h (J 6 2 The Form 313 A [AUD] of Dr Roberto A Annexy Marquez 3 The Form 313 A [AUT] of Dr Roberto A Annexy Marquez 4 Copy of the Certification indicating that Dr Annexy fulfilled the requirements of his

Postgraduate Medical Education Training Program in the Specialty of Nuclear Medicine at the University of Puerto Rico Medical Sciences Campus

5 Copy of the Certificate that indicates that Dr Annexy met the requirements of the American 80ard of Nuclear Medicine

6 Copy of the license 16811 from Commonwealth of Puerto Rico Department of Health of Puerto Rico 80ard of Medical Examiners of Dr Annexy

7 Copy of the Controlled Substances Registration Certificate of Dr Annexy

Amendment 3 We also request you to update the mailing address and the name of our facility in your records as they have changed The correct information should read

San Patricio MEDFLIX 280 Marginal Kennedy Guaynabo PR 00968

Please contact us for any additional information at phone number (787) 620-5757

Thank you

Carlos Jimenez Marchan MD Director Nuclear Medicine Department San Patricio MEDFLIX

280 Marginal Kennedy Guaynabo PR 00968 -Tel 787 620 5757 bull Fax 787 620 5761 bull wwwsanpatriciomedflixcom

iNRtgtrORM 313A (AUO)

US NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION

APPROVED BY O~1BINO 3150middot0120 EXPIRES 33112012

(for uses defined under 35100 35200 and 35500) [10 CFR 3519035290 and 35590]

l~0091

Name of Proposed Aulhorlzed User

Dr Roberto Annexy

State or Territory Where Licensed

Puerto Rlto

Requested Aulhorizatlon(s) (check all that apply)

[] 35100 Uptake dilution and excretion studies

[ZJ 35200 Imaging and localization studies

o 35500 Sealed sources for diagnosis (specify device ___________)

PART bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)

Training and Experience includi board certification must have been obtained within the 7 years preceding the date of application or the I dual must have obtainedrelated continuing education and experience since the requIred training and experience was completed Provide dates duration and description of continuing education and experience related to the uses checked above

(lJ 1 Board Certification

a Provide a copy of the board certlfloation

b If using only 35500 materials stop here If using 35100 and 35200 materIals skip to and complete Part II Preceptor Attestation

o 2 Current 35390 Authorized User Seeking Additional 35290 Authorization

a Authorized user on Materials License meeting 10 CFR 35390 or equivalent Agreement-----------shy State requirements seeking authorIzation for 35290

b Supervised Work Experience(If more than one supeNsing Individual Is necessary to document supeNised work experience provide multiplecopies of this section)

Description of Experience location of ExperienceLicense or

Permit Number of Facility Clock Hours

Oates of Experience

Eluting generator systems approprIate for the preparation of radIoactive drugs tor imaging and localization studies measuring and testing the eluate for radlonuclidic purity and processing the eluate with reagent kits to prepare labeled radioactive drugs

Total Hours of Experience

Supervising Individual ILicensePermit Number listing supervising Individual as an authorized user

I u HUUU uu~~~u n Hujf ~HU bullbullbullbullbull u u u HUunu bullbulluUl u

Supervisor meets the reqUirements below or equivalent Agreement State requirements (check all that apply)

035290 035390 + generator experience In 32290(c(1)(U)(G)

NRC FORM 313A(AUD) (3middot2009) PRIIlTED 011 RECYCLE PAPER PAGE t

~ORM 313A (AUD) us NUCLEAR REGULATORY COMMISSION

) AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (conllnued)

I 1D 3 Trilnlng am EXl29rlem~o for frol2osed Autb2[I~ed US[

s Classroom and Laboratory Training

Description of Training Location of Training Clock Hours

Dates of Training

Radiation physics and Instrumentation

Radiation protection I I

Mathematics pertainIng to the use and measurement of radioactivity

Chemistry of byproduot material for medical use (not required for 35590)

I

Radiation biology bull

Total Hours of Training b SupsNlsed Work Experience (completion of this table Is not required for 35590)

(Ifmore than one supervising Individual s necessary to document supervised work experienoe provide multiple copies of this section)

SupervIsed Work Experience Iotal Hours of Experience

Description of Experience Must Include

Location of ExperienceLicense or Permit Number of Facility Confirm Dates of

Experiencemiddot

Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys

OmiddotYes

DNo

Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters

DYes

ONo

PAGI2

A (AUO) US NUC1EAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3 TraIning and Experience for Proposed Authorized Usee (continued) i b Supervised Work Experience (continued)

DatesofDelcrlpllon of Experience locatlon df Ixperiencellqel)se or ConfirmMust Include ExperiencemiddotPermit Number of FacUlty

Calculating measuring and safely DYes preparing patient or human research subject dosages DNo

Using administrative controls to DYes prevent a medical event Involving the use of unsealed byproduct material DNa

Using procedures to contain spilled DYes

shybyproduct material safely and using proper decontamination procedures DNo

Administering dosages of radioactive DYes drugs to patients or human research subjects oNo

Eluting generator systems appropriate DYesfor the preparation of radioactive drugs for Imaging and localization DNostUdies measuring and testing the ~Iuate for radionuclldlc purity and processing the elUate with reagent kits to prepare labeled radioactive drugs

Supervising IndMdual LicensefPermll Number listing supervising Individual as an aulhorized user

u u bullbullbull bull bull bullbullu u bullbullu bullbullbull t tU~9 bullbullbulln u nubullbullbullbullbullu bullbullbullbull bull middotmiddotuumiddotmiddotuu UHUmiddot bull middot u u u _uu uuu

Supervisor meets Ihe reqUirements belltwJ or equivalent Agreement State requirements (check one)

035190 035290 035390 035390 + generator experience In 3S290(c)(1)(IIG)

c For 35590 only provide documentation of training on use of the device

Device Type of Training Location and Dates

d For 35500 uses only stop here For 35100 and 35200 uses skip to and complete Part II Preceptor Attestation

PAGE 3

_~~

~A (AUO) US NUCLEAR REGULATORY COMMISSION

~6~HORtZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PARTII-PRECEPTORATTESTATION I Note This part must be completed by the Individuals preceptor The preceptor does not have to be the supervising

Individual as long as the preceptor provides dlr~ct$ or verifies training and experience required If more than one preceptor is necessary to document experience obtain a separate preceptor statement from each Not requIred to meet traIning requirements In 35590 bull

By checking the boxes below the preceptor Is attesting that the Individual hyenls koowledge to fulfill the duties of the position sought and not attesting to the Individuals general cUnlcal competency

First Section Check ono of the following for each use requested

For 35190

Board Certification [lJ I attest that Dr Roberto Annexy has satisfactorily completed the requirements In-

Name of ProPOSed Aulhotted User bull

10 CFR 35190(a)(1) and has achieved a lavel of competency sufficient to function Independently as an authorized user for the medical uses authorized under 10 CFR 35100

Training and Experience

o I attest that Name of Proposed Aulhoriled User

OR

h~ satisfactorily completed the 60 hours of training and

experience including a minimum of 8 hours of classroom and laboratory training required by 10 CFR 35190(c)(1) and has achieved a level of competency sufficient to fUnction independently as an authorized user for the medical uses authorized under 10 CFR 35100

For 3529Q Board Cetllflcatfon

[l] I attest that Dr Roberto Annexy has satisfactorily completed the requirements In Name of PloPO$Gd AUlhorized USSl

10 CFR 35290(a)(1) and has achieved a level of competency sufficient to fUnction independently as an authorized user for the medical Clses authorized under 10 CFR 35100 and 35200

TraInIng and Experience


OR

has satisfactorily completed the 700 hours of training

and experience IncludIng a minimum of 80 hours of classroom and laboratory traIning required by 10 CFR 35290(c)(1) and has achieved a level of competency SUfficient to function independEJntly as an authorized user for the medical uses authorized under 10 CFR 35100 and 35200

bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullwbullbullbull~bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull Second Section Complete the following for preceptor attestation and signature

[I I meet the requirements below or equivalent Agreement State reqUirements as an authorized user for

035190 (Z] 35290 035390 [lJ35390 + generator experience

Nama of Preceptor

Dra Frieda Sliva Signature f) -tn~A~I

Telephone Number

(787) 625middot9958

Dale

08311l0n

LicensePermit NumberFaclilly Nama 52middot01946middot07

PAGE 4

US NUCLEAR REGULATORY COMMISSION NRC FORM wi(lAUT) (320001 ~-

AUTHoRIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON

APPROVED BY OMB ~O131600120 EXPIRES 33112012

(for uses defined under 35300) [10 CFR 353903539235394 and 35396]

OR

o 35300 Oral administration of sodium Iodide 1-131 requiring a written directive In quantities less than or equal to 122 glgabecquerels (33 mlllicuries) bull bull

o 35300 Oral administration of sodium Iodide 1-131 requiring a written directive in quantities greater than 122 glgabecquerels (33 mllilcurles) bull bull

o 35300 Parenteral administration of any beta-emitter or photon-emllling radionucllde with a photon energy less than 150 keV for which a written directive Is required

o 35300 Parenteral administration of any other radionuclide for which a written directive Is required

PART 1--TRAINING AND EXPERIENCE (Select one of the three method beow)

rraining and Experience Including board certification must have been obtained within the 7 years precedJn~ the date of application or the individual must have related continuing education and experience since the required training and experience was completed Provide dates duration and description of continuing education and experience related to the uses checked above

1]1 Board Certification

a Provide a copy of the board certification

b For 35390 provide documentation on supervised clinical case experience The table in section 3c may be use4 to documentthlsmiddot expllrience

c For 35396 provldedocumentatloi-on crassr-oom-and laboratory training supervised work experience and supervised clinical case experlence The fables In sections 3a l 3b and 3c may be used to document this experience

d Skip to and complete Part II Preceptor Attestation

J 2 CUrrent 3530035400 or 35600 Authorized US9r Seeking Additional Authorlza1ion

a Authorized User on Materials license ------------------~-

under the requirements below or equivalent Agreement State requirements (check all that apply)

035390 0 35392 035394 035490 035690

b If currently authorized for a subset of clinical uses under 35300 provide documentation on additional required supervised case experience The table In section 3c may be used to document this experience Also provide completed Part II Preceptor Attestation

c If currently authorized under 35490 or 35690 and requesting authorization for 35396 provide documentatron on classroom and laboratory training supervised work experience and supervised clinical case experience The tables In sections 3a 3b and 3c may be used to document this experIence Also provide completed Part II Preceptor Attestation

iRe FORM 31M (AUT) (3-2000) PRIIITEO ON RECYCLE) PAPER PAGEl

Name of Proposed Authorlzed User

Dr Roberto Annuy

State or Territory Alhere Licensed

Puerto Rico bull

Requested Authorlzatlon(s) (check-all that apply) I

[l] 35300 Usa of unsealed byproduct material for which a written directive Is required bull

~ 00l)

FORM li3A (AUT) US NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued) 1

a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 3 Trllnln9 and Exru~rl9nce for Pro12osag Authorized User

Description of Training

o

location of Training Clock Hours

Dates of Training


Radiation protection

Mathematics pertaining to the use and measurement of radioactivity

Chemistry of byproduct material for medical use

Radiation biology

Total Hours of Training

b Supervised Work Experience D 35390 035392 035394 035396shyIfmore than one supeTVIsing Individual Is necessary to document supervised training provide multiple copies of this page

Supervised Work Experience Total Hour~ of Experience


Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of

Experience


DVes

DNo

PerformIng quality control procedures on Instruments used to determine the activityof dosages and performing checks for proper operation of survey meters

DVes

DNo

Calculating measuring and safely preparin~ patient or human researc subject dosages

Dves

DNo

Using administrative controls to prevent a medical event involving the use of unsealed byproduct material

~

DYes

DNo

Using procedures to contain spilled byproduct material safely and using proper decontamination procedures

DYes

DNo

PAGE 2

~

r - middot~RM~13A (AUT) US NUCLEAR REGULATORY COMMISSION

r - AUTHORIZED USER TRAINING AND EXPERIENCE ANI) PRECEPTOR ATTESTATION (continued)

3 training and Experience for Proposed AuthorIzed User (continued) I

b Supervised Work Exper[ence (continued) bull

SupervisIng Individual LIcensePermit Number listing supervising Individual as an authorized user _

Dr Roberto Annexy 52-01946-07 ~ ~ ~ ~ bullbullbullbull bullbullbullbullbull ~ ~ bullbull ~o~ ~ bullbull bullbullbull

Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply) ~ 9 bull I bullbullbullbullbullbull t 9 ~ I bullbull 0shy bullbull l bullbullbullbullbullbull

035390

[Z] 35392

I] 35394

035396

~ With experience administering dosages of

G1 Oral Nalmiddot131 requiring a written directive In quantities less than or equal to 122 glgsbecquerels (33 mlllicuries) ~ CErOral Nalmiddot131 in quantities greater than 122 glgabecquerels 33 millicuries 0 Parenteral administration of beta-emitter or photon-emltllng radionuclide with a photon energy less than 150 keY requiring a written directive Is required 0 Parenteral admlnlstrallon of any other radlonucllde requiring a written dlrectwe

- ~ bull ~ ~ ~ $

SupsVIslng Authorized User must have experlanceln adminIstering dosages In the serna dosage calegOlY or categories as the IndivIdual requElsUng authorized userslatus

c SupelVised Clinical Case Experience Ifmora than one supervising Individual Is necessary to document supervised work experience provide multfple copies of this page

Description of Experience

Oral adm[nlstratlon of sodium Iodide 1-131 reqUiring a written directive In quantitIes less than

or equal to 122 glgabecquerels (33 millcurles)

Oral administration of sodium iodide 1-131 requiring a written directive In quantities greater than 122 glgabecquerels (33 millicuries)

Parenteral administration of any beta-emitter or photon-emitting radlonucllde with a photon energy less than 150 keY for which a written dIrective Is required

Parenteral admInistratIon of any other radlonucllde for

which a written directive Is required

Ilisl raclfonuclldes)

Number of Cases Involv[ng Personal

Participation

8

Locellon of ExperienceLicense or Permit Number ofFacllity

Dates of Experience

University or Puerto RIco Medical Sciences 0710112007 to Campus Nuclear Medicine ResIdency Program 06302009 52-01946-07

University of Puerto Rko Medical ScIences 0701l007 to Campus Nuclear Medicine Residency Program 061302009 52-01946middot07

PAGE 3

313A (AUT) us NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION uod)

rDlnlng and ExperIence for Proposed AythQrlzgd User (oontlnued)

c Supervised Clinical Case Experience (conll~ued)

Supervlsin(J Individual LlcensePermlt Number listing supervising Individual as an authorized user

Dra Frieda SlIvll 51-0194607

Supervisliig iridivfduai meets ilierequlrements beiow or equlvalenf Agreementstate requlremeots (cHeck ali that apply) ~ bullbullbull t bullbullbullbullbullbullbull ~~ ~ ~ bullbull

035390 middot Wth experience administering dosages or middot middot [Z] 35392 middot [i] Oral Nal-131 requiring a written directive In quantities less than or equal to 122middot gJgabecquerels 33 mlillcuries) [] 35394 middot middot middot [] Oral Nal-131In quantities greater than 122 gJgabecquerels (33 millicuries) middot 035396 middot

middot middot o Parenteral administration of beta-emmer or photon-emitting radlonuclide with a photon

energy less than 150 keY requiring awritten directive Is requiredmiddot middot middoto Parenteral administration of any other radionucllde requiring a written directw9 bull ~ 11 bull bull ~ bull I t f

SupelVlslng Authorized User must have experience 111 adminIstering dosages In the same dosage category or categories as IhulndlvldlJal requesllng authorized user status

d Provide completed Part II Preceptor Attestation

PART 11- PRECEPTOR ATIESTATION

Note This part must be completed by the Individuals preceptor The preceptor does not have to be the supervising Individual as long as the preceptor provides directs or verifies training an experience required If more than one preceptor Is necessary to document experience obtain a separate preceptor statement from each

By checking the boxes below the preceptor Is attesting that the Individual has knowledge to fulfill the duties of the posltlon sought and not attesting to the Individuals general clinical competency

First Section Check one ofthe followIng for each requested authorization

For 35390

Board Certification

o I attest that Dr Roberto Annexy has satisfactorily completed the training and experience Neme or Proposed Authorized Unr

requirements In 35390(a)(1

OR

Training and Experlence

o I attest that has satisfactorily completed the 700 hours of training --~~~~--~~~~~shyName of Proposed Authorized User

an~ experience Including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)

PAGE 4

JF~iO-RM~~1-3A-(-AU-T-)--------------------U--S-N-U-CL-e-A-R-RE-G-U-LA-r-O-RY-C-O-MMIS2OO9

1 AUTHORIZED USERTRAININGAND EXPERIENCE AND PRECEPTORATIESTATION (continued)

-SI~O~N

Fourth Section

For 35396

purrent 35490 or 35690 authorized user

o I attest that Name or Proposed Authomed User

I

is an authorized user under 10 CFR 35490 or 35690

or equivalent Agreement State requirements has satisfactorily completed the 80 hours of classroom and laboratory training as required by 10 CFR 35396 (d)1) and the supervised wcrk and clinical case experience required by 35396(d)(2 and has achieved a level of competenc~ sufficient to function Independently as an authorIzed user for

o Parenteral admlnlstraUon of any beta-emitter or photon-emitting radlonucllde with a photon energy less than 150 keV for which a written directive Is required bull

o Parenteral administration of any other radlonucllde for which a written directive is required

OR Board Certification

o I attest that has satisfactorily completed the board certification Name of Ploposed Authorized User

requirements of 35396(c) has satisfactorily completed the 80 hours of classroom and laboratory training requIred by 10 CFR 35396 (d)(1) and the supelVised work and clinical case experience required by 35396(d)(2) and has achieved a laval of competency sufficient to function Independently as an authorized user for

o Parenteral administration of any betaemitter or photon-emitting radlonuclide with a photon anergy less than 150 keY for Which a written directive Is required bull

o Parenteral admlnstration of any other radlonucllde for which a written directive Is requIred ~ bullbullbullbullbullbullbullbullbullbullbull M_ bullbullbullbullbullbull _ bullbullbullbullbullbullbullbullbullbullbullbullbullbullbullbull _ bullbullbullbull __ bullbullbullbullbull _ bullbullbullbull bullbullbullbull

Fifth Section Complete the following for preceptor attestation and signature

I] I meet the requirements below or equivalent Agreement State requirements as an authorized user for

~35390 ] 35392 035394 035396

o I have experience administering dosages In the following categories for which the proposed Authorized User Is requesting authorlzatron

o Oral Nal-131 requiring a written directive In quantitles less than or equal to 122 glgabecquerels (33 millicurles) bull

[ZJ Oral Nalmiddot131In quantities greater than 122 glgabecquerels(33 mlllicurles)

o Parenteral administration of beta-emitter or photon-emitting radlonucllde with a photon energy less than 150 keY requiring a written directive Is required

D Parenteral adml~lstration of any other radlonu~lIde requiring a written dIrective

bull

bull

_

Name of Preceptor DrA Frleda SIva

Telephone Number

(787) 625middot9958

Date

09fOlllOll

LicensePermit NumberFacility Name 52middot01946middot01

I

PAGE 6

Director ofTraining Program

mdver~ of Puerto Rico MeDical sciences campus

school of MeOiciHe anD AffjljatOO Hospital Graimate MeDical Mucatloo

lttertifitation

It is bereby certified that

has fulfilled the requirements of the

Postgraduate Medical Education Training Program

in the Specialty of

~udeat tilebitille effective June 30 2009

This specialty training was conducted under the sponsorship of the

~tbool regf jlf[ebitine Given at San Juan Puerto Rico on May 15 2009

laquo4d ~~Plsect) ~imf4-Assistant Dean

Graduate Medical Education Dean

School of Medicine

C mrperSOIl of Departmellt

and to inform you that the initial processing which

This is to aCknowlerdge the receipt of your lette application ated

____1 t15 d 0 Ii includes an administrative review has been performed

~ThFlPftcl~~~~i tL~a~pC~I)was assigned to a technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our license Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number Popound Z (5tr When calling to inquire about this action please refer to this control number You may call us on (610) 337middot5398 or 337middot5260

NRC FORM 532 (RI) Sincerely (6-96) Licensing Assistance Team Leader

SAN PATRICIO

MEDFLIX E DLAGN6STICO rvlAs

December 15 2011

Licensing Assistance Team Division of Nuclear Materials Safety US Nuclear Regulatory Commission Region I 475 Allendale Road King of Prussia PA 19406-1415

ltgt Carlos Jimenez Marchan MD W

NSan Patricio MRI amp CT Center 1508 Roosevelt Avenue Suite 103 San Juan PR 00920

SAN PATRICIO MRI amp CT CENTER REQUEST FOR AMENDMENT TO LICENSE NUMBER 52-31166-01

Please amend the NRC license 52-31166-01 of the San Patricio MRI amp CT Center Facility as follows

Amendment 1

Please add to this license the 10 CFR Part 35300 that applies for the use of unsealed byproduct material for which a written directive is required We will be using exclusively lodine-131 for therapies permitted by 10 CFR 35300 when approved by NRC This will be limited to outpatients who may be released in accordance with the requirements in 10 CFR 3575 Also documents regarding the iodine -131 treatment will be written and available

The name of the AU for part 1 0 CFR 35300 is

bull Dr Carlos E Jimenez Marchan Nuclear Medicine Physician and the Radiation Control Program Director for this facility

bull License 11046 from Commonwealth of Puerto Rico Department of Health of Puerto Rico Board of Medical Examiners

bull Previous license number on which the physician was specifically named as an AU 11810-02 for Parts 35100 200 and 300

280 Marginal Kennedy Guaynabo PR 00968 -Tel 787 620 5757 - Fax 787 620 5761 -wwwsanpatriciomedflixcom

SAN PATRICIO

MEDFLIX

Amendment 2














Thank you








l~0091


Dr Roberto Annexy


Puerto Rlto















Oates of Experience













Dates of Training





I







Experiencemiddot


OmiddotYes

DNo


DYes

ONo

PAGI2


















PAGE 3

_~~







For 35190






OR








OR






Nama of Preceptor


Telephone Number

(787) 625middot9958

Dale

08311l0n


PAGE 4





OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine










SAN PATRICIO

MEDFLIX

Amendment 2














Thank you








l~0091


Dr Roberto Annexy


Puerto Rlto















Oates of Experience













Dates of Training





I







Experiencemiddot


OmiddotYes

DNo


DYes

ONo

PAGI2


















PAGE 3

_~~







For 35190






OR








OR






Nama of Preceptor


Telephone Number

(787) 625middot9958

Dale

08311l0n


PAGE 4





OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine















l~0091


Dr Roberto Annexy


Puerto Rlto















Oates of Experience













Dates of Training





I







Experiencemiddot


OmiddotYes

DNo


DYes

ONo

PAGI2


















PAGE 3

_~~







For 35190






OR








OR






Nama of Preceptor


Telephone Number

(787) 625middot9958

Dale

08311l0n


PAGE 4





OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine















Dates of Training





I







Experiencemiddot


OmiddotYes

DNo


DYes

ONo

PAGI2


















PAGE 3

_~~







For 35190






OR








OR






Nama of Preceptor


Telephone Number

(787) 625middot9958

Dale

08311l0n


PAGE 4





OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine



























PAGE 3

_~~







For 35190






OR








OR






Nama of Preceptor


Telephone Number

(787) 625middot9958

Dale

08311l0n


PAGE 4





OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine










_~~







For 35190






OR








OR






Nama of Preceptor


Telephone Number

(787) 625middot9958

Dale

08311l0n


PAGE 4





OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine














OR















035390 0 35392 035394 035490 035690





Dr Roberto Annuy


Puerto Rico bull



~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine










~ 00l)





o


Dates of Training





Radiation biology






Experience


DVes

DNo


DVes

DNo


Dves

DNo


~

DYes

DNo


DYes

DNo

PAGE 2

~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine










~








035390

[Z] 35392

I] 35394

035396



- ~ bull ~ ~ ~ $












Participation

8


Dates of Experience



PAGE 3

















For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine


























For 35390

Board Certification



OR




PAGE 4



-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine












-SI~O~N

Fourth Section

For 35396



I












~35390 ] 35392 035394 035396






bull

bull

_


Telephone Number

(787) 625middot9958

Date

09fOlllOll


I

PAGE 6




lttertifitation




in the Specialty of






School of Medicine













lttertifitation




in the Specialty of






School of Medicine


















Documents

San Patricio MRI & CT Center, Amendment Request