NRC FORM 313 U.S. NUCLEAR REGULATORY COMMISSION rs. formation nd ollection onduct ollection. PPROVED BY OMS: NO. 3150·0120 EXPIRES: 3131/2012 (3-2009) 10 CfR 30, 32, 33 Estimated burden per response to comply with this mandatory collection request: 4.3 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 FOIAIPriv'ac1f Sien'ice,s! (T·5·F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555·0001, APPLICATION FOR MATERIAL LICENSE by internet e-mail to [email protected], and to the Desk Officer, Office 0 and Regulatory Affairs, NEOB- 10202, (3150·0120), 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- 1 ""N=S=TR=U"7C C ""=T=IO""'"N=S-; SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED B:.::E:.::Lc:: W :.:-. --------1 0 .:.: APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH: OFFICE OF FEDERAL & SATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS U.S. 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 U.S. 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 U.S. 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 U.S, NUCLEAR REGULATORY COMMISSION JURISDICTIONS, i 1. THIS IS AN APPLICATION FOR (Check appropriate item) , 0 NUCLEAR MATERIALS LICENSING BRANCH 0 U.S. NUCLEAR REGULATORY COMMISSION, REGION IV 612 E. LAMAR BOULEVARD, SUITE 400 o 7:>031 ).).(, PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. 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 1'71 San Patricio MRI & CT Center IL:::J B. AMENDMENT TO LICENSE NUMBER 52-31166-01 280 Marginal Kennedy o 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 r San Patricio MEDFLIX (787) 607-3666 ! Avenida J. F. Kennedy Marginal Buchanan. km. 5.0 Carretera Estatal PR-2 Barrio Pueblo Viejo /' Guaynabo, Puerto Rico 00968. TO =BE IS D=ESCRIBE=D GU=-=--IDE -- SC=OPE PROV=IDED APPLlCA=TION IN SUBMITITEMS' THROUGH 11 ON 81/2 X 11" PAPER ==THE '5:RAbIOACTIVE 6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WilL BE USED. I a. Element and mass number; b, chemical and/or physical form; and c, maximum amount which will be possessed at anyone time. Same Same I '7. INDIVIDUAL(Sj RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR 8. TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS. TRAINING EXPERIENCE. Same Same 1 9 FACILITIES AND EQUIPMENT. 10. RADIATION SAFETY PROGRAM. I Same Same 111 WASTE MANAGEMENT 12. LICENSEE FEES (See 10 CFR 170 and Section 170.31) 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 INI'ORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF, WARNING: 18 U.S.C. SECTION 1001 ACT OF JUNE 25, 194862 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO SIGNATURE DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MADER WITHIN ITS JURISDICTION. CERTIFYING OFFICER - TYPED/PRINTED NAME AND TITLE i Carlos Jimenez Marchan. MD II .. ! TYPE OF FEE / FEE LOG FEE CATEGORY RECEIVED I NRC FORM 313 (3-2009) PRINTED ON RECYCLED PAPER - NMSSlRGN1 MXratlALS..()02 I
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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
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
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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
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
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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
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
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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
~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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
_~~
~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
o I attest that Name of Proposed Aulhoriled User
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
~ 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 physics and Instrumentation
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
Description of Experience Must Include
Location of ExperienceLl~ense or Permit Number of Facility Confirm Dates of
Experience
Ordering receiving and unpacking radioactive materials safely and performing the related radiation surveys
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 _
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)
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
~
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 _
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)
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
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)
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
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
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
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