Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
Radiology 200 Jefferson SE Grand Rapids MI 49503 g HEALTH CARE Phone 6166856744 FAX 6166853066 wwwsmhealthcareorg
r1jj SAINT MARYS
December 19 2012
Materials Licensing Branch US Nuclear Regulatory Commission Region III 2443 Warrenville Road Suite 210 Lisle Illinois 60532-4352
RE Amendment of License 21-01078-01
To whom it may concern
Please amend our radioactive material license as follows
Item 12 Add Matthew A Tiede MD as an Authorized User for Y-90 microspheres in group 351000 for brachytherapy at any site
Training and Experience for Y-90 as listed in Microsphere Brachytherapy Sources and Devices REVISED JUNE 2012 bull Training requirements in A3ii 80 hours of classroom and laboratory training is documented in the
Form 313A signed by Dr Chad Williams bull Work experience under the supervision of an AU for Y-90 microspheres as required in A3iii This
experience is documented by both Dr Chad Williams and Dr Richard N Joynch (21-04127-02) bull Training in the operation of the delivery system safety procedures and clinical use for each type of Yshy
90 microspheres as required in B pathway 1 This training is documented by both Dr Chad Williams and Dr Richard N Joynch on the submitted NRC 313A Forms
Add Matthew A Tiede MD as an Authorized User for 35392 bull Dr Tiedes ABR certificate is attached to fulfill the requirements as listed in 35390 a
Add Matthew A Tiede MD as an Authorized User for 35394 bull Dr Tiedes training and work experience including the 3 supervised clinical cases is documented in
the attached NRC Form 313A signed by Dr Chad Williams
Recentness of Training bull Some of Dr Tiedes training and experience is not within the last 7 years Documentation is
attached to show recent involvement in the areas of use requested bull Nordion TheraSphere Y-90 Glass Microsphere Training Jun 2 2010 bull Society of Interventional Radiologys Y90 Are you ready course Feb 10-132011 (26 hours) bull Nordion Advanced Users Meeting Feb 24 2012 (8 hours)
Sincerely
Db~Julu~ ~p~Dale Schippers -~O I Earl Monks r Radiation Safety Officer Director of Radiology
RECEJVpoundD DEC 2~ 1e12
NRC letter add Drs Tiede ampRapoport Nov2012doc
SOCIETYOF ~ INTERVENTIONAL RADIOLOGY Enhanced care through advallced technologygt
The Society ofIn terven tiona I Radiology Certificate ofCompletion
Matthew A Tiede MD
has completed 26 hours of course work and successfully passed a formal examination in the following areas during the Society ofInterventional Radiologys Y90 Are yoU ready course held February 1O~13 2011 in Scottsdale Arizona The course content was based upon the
Nuclear Regulatory Commissions Microsphere Brachytherapy Sources and Devices Licensing Guidance - TheraSphereAreg and SIR-SpheresAreg Yttrium-90 Microspheres revised January 2011 as related to Authorized Use (AU) status for intra-arterial Y90 in the treatment
of hepatic malignancies
In witness whereof we have hereunto affixed our signatures Society of Interventional Radiology - Fairfax Virginia March 182011
(tt~~ RiId Salem ID MBA FSlIl BlimP StJinkImMDPSIR no Program~ no Progmn COOldinafor
J~f~Pb James F Bamali MD FSIR
SIR PresideIrt
nordion SCIfNCE ADVANCING HEALTH
March 142012
To Whom It May Concern
BE TheraSphere V-gO Glassect Micmsectphere Training
Matthew Tiede participated in an eight (8) hour training program at an Advanced User Meeting hosted by Nordjon Inc on February 242012 The meeting focused on TheraSphere advanced techniques and practices for the treatment of hepatocellular carcinoma The training was moderated by Biad Salem MD MBA and presenters included leading authorities on V-90 Glass Microsphere therapy
If you have any questions please do not hesitate to contact me
Yours sincerely
~~ Jackie Groff
Global ~rand Manager TheraSphere Nordion
JMGrnl
cc Clinical Account Manager
447 MARCH RD OTTAWA ON CANADA K2K lxa T+1613-592-2790 F+1613-592-6815 wwwnordloncom
447 Mitrch [xtd Tel +1 (in 592-2790 Ottilwa Onwrio jax +1 613 5()-W37 f2K 1XII Canadl wwwn1d~no1diuncon1
~ Nordion
June 292010
Dale Shippers Saint Marys Health Care 200 Jefferson St SE Grand Rapids MI 49503
Dear Mr Shippers
RE TheraSphere Y -90 Glass Microsphere Training
The individuals listed below participated in a training program at Northwestern Memorial Hospital on the use of TheraSpherereg Yttrium-90 Glass Microspheres for the treatment of hepatocellular carcinoma which was presented by MDS Nordion representatives on June 2 20 10
Mr Dale Shippers Mr Tewfik Bichay Dr Matt Tiede Dr Charles Wilkinson Dr Zdravko Skrtic Dr Gilbert Padula Mr Jim Lafarge
This vendor training program meets the requirements for training and experience specified in paragraph two of the Nuclear Regulatory Commission Guidance Microsphere Brachytherapy Sources and Devices revised September 2008
If you have any questions please do not hesitate to contact me
Yours sincerely
MDS Nordion
lj shymBurnett
Vice-President Global Sales
TBsl cc Mark Jordan MDS Nordion
NRC FORM 31lA (AUT) lamiddot20091
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMB NO 3150(1120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
Requested Authorization(s) (cheCk all that apply)
State or Territory Where licensed
Mkhlgao
Use of Y-90 microspheres in group 351000 for brachytherapy at any site
OR
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a wntten directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
bull Training and Experience including board certification must have been obtained within the 7 years preceding 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 Board Certification
a Provide a copy of the board certification
b For 35390 provide documentation on supervised clinical case experience The table 10 section 3c may be used to document this experience
c For 35396 provide documentation on classroom and laboratory training supervised work experience and supennsed clinical case experience The tables in sections 3a 3b and 3c may be used to document this experience
d Skip to and complete Part II Preceptor Attestation
2 Current 35300 35400 or 35800 Authorized User Seeking Additional Authorizalon
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
35390 35392 35394 35490 35690
b If currently authorized for a subset of clinical uses under 35300 prOVide documentation on additional required supervised case experience The table in section 3e 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 documentation 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 1 Preceptor Attestation
NRC FORM 3134 (AUT) (3middot2009) PRINTED ON RECYCLED PAPER PAGE 1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
-I 3 Training and Experience for Proposed Authorized Uur a Classroom and Laboratory Training 35390 35392 35394 35396
Clock Dates ofDescription of Training Location of Training Hours 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 Interventional Radiology pathway for Y90 microsphere training
If more than one supervising individual is necessary to document supervised framing provide multiple cOpies of this page
Supervised Work Experlenee Total Hours of 1 yearExperience
Description of Experience Location of ExperienceLicense or Dates of ConfirmMust Include Permit Number of Facility Experiencemiddot
Ordering receiving and unpacking radioactive Ves materials safely and performing Nothe related radiation surveys
Performing quality control procedures on instruments Ves used to determine the activity Noof dosages and performing checks for proper operation of survey meters
Calculating measuring and Ves safely preparing patient or human research subject No dosages
Using administrative controls to Ves prevent a medical event involving the use of unsealed No byproduct material
Using procedures to contain -I Ves spilled byproduct material safely and using proper No decontamination procedures
PAGE 2
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
SOCIETYOF ~ INTERVENTIONAL RADIOLOGY Enhanced care through advallced technologygt
The Society ofIn terven tiona I Radiology Certificate ofCompletion
Matthew A Tiede MD
has completed 26 hours of course work and successfully passed a formal examination in the following areas during the Society ofInterventional Radiologys Y90 Are yoU ready course held February 1O~13 2011 in Scottsdale Arizona The course content was based upon the
Nuclear Regulatory Commissions Microsphere Brachytherapy Sources and Devices Licensing Guidance - TheraSphereAreg and SIR-SpheresAreg Yttrium-90 Microspheres revised January 2011 as related to Authorized Use (AU) status for intra-arterial Y90 in the treatment
of hepatic malignancies
In witness whereof we have hereunto affixed our signatures Society of Interventional Radiology - Fairfax Virginia March 182011
(tt~~ RiId Salem ID MBA FSlIl BlimP StJinkImMDPSIR no Program~ no Progmn COOldinafor
J~f~Pb James F Bamali MD FSIR
SIR PresideIrt
nordion SCIfNCE ADVANCING HEALTH
March 142012
To Whom It May Concern
BE TheraSphere V-gO Glassect Micmsectphere Training
Matthew Tiede participated in an eight (8) hour training program at an Advanced User Meeting hosted by Nordjon Inc on February 242012 The meeting focused on TheraSphere advanced techniques and practices for the treatment of hepatocellular carcinoma The training was moderated by Biad Salem MD MBA and presenters included leading authorities on V-90 Glass Microsphere therapy
If you have any questions please do not hesitate to contact me
Yours sincerely
~~ Jackie Groff
Global ~rand Manager TheraSphere Nordion
JMGrnl
cc Clinical Account Manager
447 MARCH RD OTTAWA ON CANADA K2K lxa T+1613-592-2790 F+1613-592-6815 wwwnordloncom
447 Mitrch [xtd Tel +1 (in 592-2790 Ottilwa Onwrio jax +1 613 5()-W37 f2K 1XII Canadl wwwn1d~no1diuncon1
~ Nordion
June 292010
Dale Shippers Saint Marys Health Care 200 Jefferson St SE Grand Rapids MI 49503
Dear Mr Shippers
RE TheraSphere Y -90 Glass Microsphere Training
The individuals listed below participated in a training program at Northwestern Memorial Hospital on the use of TheraSpherereg Yttrium-90 Glass Microspheres for the treatment of hepatocellular carcinoma which was presented by MDS Nordion representatives on June 2 20 10
Mr Dale Shippers Mr Tewfik Bichay Dr Matt Tiede Dr Charles Wilkinson Dr Zdravko Skrtic Dr Gilbert Padula Mr Jim Lafarge
This vendor training program meets the requirements for training and experience specified in paragraph two of the Nuclear Regulatory Commission Guidance Microsphere Brachytherapy Sources and Devices revised September 2008
If you have any questions please do not hesitate to contact me
Yours sincerely
MDS Nordion
lj shymBurnett
Vice-President Global Sales
TBsl cc Mark Jordan MDS Nordion
NRC FORM 31lA (AUT) lamiddot20091
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMB NO 3150(1120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
Requested Authorization(s) (cheCk all that apply)
State or Territory Where licensed
Mkhlgao
Use of Y-90 microspheres in group 351000 for brachytherapy at any site
OR
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a wntten directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
bull Training and Experience including board certification must have been obtained within the 7 years preceding 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 Board Certification
a Provide a copy of the board certification
b For 35390 provide documentation on supervised clinical case experience The table 10 section 3c may be used to document this experience
c For 35396 provide documentation on classroom and laboratory training supervised work experience and supennsed clinical case experience The tables in sections 3a 3b and 3c may be used to document this experience
d Skip to and complete Part II Preceptor Attestation
2 Current 35300 35400 or 35800 Authorized User Seeking Additional Authorizalon
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
35390 35392 35394 35490 35690
b If currently authorized for a subset of clinical uses under 35300 prOVide documentation on additional required supervised case experience The table in section 3e 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 documentation 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 1 Preceptor Attestation
NRC FORM 3134 (AUT) (3middot2009) PRINTED ON RECYCLED PAPER PAGE 1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
-I 3 Training and Experience for Proposed Authorized Uur a Classroom and Laboratory Training 35390 35392 35394 35396
Clock Dates ofDescription of Training Location of Training Hours 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 Interventional Radiology pathway for Y90 microsphere training
If more than one supervising individual is necessary to document supervised framing provide multiple cOpies of this page
Supervised Work Experlenee Total Hours of 1 yearExperience
Description of Experience Location of ExperienceLicense or Dates of ConfirmMust Include Permit Number of Facility Experiencemiddot
Ordering receiving and unpacking radioactive Ves materials safely and performing Nothe related radiation surveys
Performing quality control procedures on instruments Ves used to determine the activity Noof dosages and performing checks for proper operation of survey meters
Calculating measuring and Ves safely preparing patient or human research subject No dosages
Using administrative controls to Ves prevent a medical event involving the use of unsealed No byproduct material
Using procedures to contain -I Ves spilled byproduct material safely and using proper No decontamination procedures
PAGE 2
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
nordion SCIfNCE ADVANCING HEALTH
March 142012
To Whom It May Concern
BE TheraSphere V-gO Glassect Micmsectphere Training
Matthew Tiede participated in an eight (8) hour training program at an Advanced User Meeting hosted by Nordjon Inc on February 242012 The meeting focused on TheraSphere advanced techniques and practices for the treatment of hepatocellular carcinoma The training was moderated by Biad Salem MD MBA and presenters included leading authorities on V-90 Glass Microsphere therapy
If you have any questions please do not hesitate to contact me
Yours sincerely
~~ Jackie Groff
Global ~rand Manager TheraSphere Nordion
JMGrnl
cc Clinical Account Manager
447 MARCH RD OTTAWA ON CANADA K2K lxa T+1613-592-2790 F+1613-592-6815 wwwnordloncom
447 Mitrch [xtd Tel +1 (in 592-2790 Ottilwa Onwrio jax +1 613 5()-W37 f2K 1XII Canadl wwwn1d~no1diuncon1
~ Nordion
June 292010
Dale Shippers Saint Marys Health Care 200 Jefferson St SE Grand Rapids MI 49503
Dear Mr Shippers
RE TheraSphere Y -90 Glass Microsphere Training
The individuals listed below participated in a training program at Northwestern Memorial Hospital on the use of TheraSpherereg Yttrium-90 Glass Microspheres for the treatment of hepatocellular carcinoma which was presented by MDS Nordion representatives on June 2 20 10
Mr Dale Shippers Mr Tewfik Bichay Dr Matt Tiede Dr Charles Wilkinson Dr Zdravko Skrtic Dr Gilbert Padula Mr Jim Lafarge
This vendor training program meets the requirements for training and experience specified in paragraph two of the Nuclear Regulatory Commission Guidance Microsphere Brachytherapy Sources and Devices revised September 2008
If you have any questions please do not hesitate to contact me
Yours sincerely
MDS Nordion
lj shymBurnett
Vice-President Global Sales
TBsl cc Mark Jordan MDS Nordion
NRC FORM 31lA (AUT) lamiddot20091
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMB NO 3150(1120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
Requested Authorization(s) (cheCk all that apply)
State or Territory Where licensed
Mkhlgao
Use of Y-90 microspheres in group 351000 for brachytherapy at any site
OR
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a wntten directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
bull Training and Experience including board certification must have been obtained within the 7 years preceding 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 Board Certification
a Provide a copy of the board certification
b For 35390 provide documentation on supervised clinical case experience The table 10 section 3c may be used to document this experience
c For 35396 provide documentation on classroom and laboratory training supervised work experience and supennsed clinical case experience The tables in sections 3a 3b and 3c may be used to document this experience
d Skip to and complete Part II Preceptor Attestation
2 Current 35300 35400 or 35800 Authorized User Seeking Additional Authorizalon
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
35390 35392 35394 35490 35690
b If currently authorized for a subset of clinical uses under 35300 prOVide documentation on additional required supervised case experience The table in section 3e 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 documentation 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 1 Preceptor Attestation
NRC FORM 3134 (AUT) (3middot2009) PRINTED ON RECYCLED PAPER PAGE 1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
-I 3 Training and Experience for Proposed Authorized Uur a Classroom and Laboratory Training 35390 35392 35394 35396
Clock Dates ofDescription of Training Location of Training Hours 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 Interventional Radiology pathway for Y90 microsphere training
If more than one supervising individual is necessary to document supervised framing provide multiple cOpies of this page
Supervised Work Experlenee Total Hours of 1 yearExperience
Description of Experience Location of ExperienceLicense or Dates of ConfirmMust Include Permit Number of Facility Experiencemiddot
Ordering receiving and unpacking radioactive Ves materials safely and performing Nothe related radiation surveys
Performing quality control procedures on instruments Ves used to determine the activity Noof dosages and performing checks for proper operation of survey meters
Calculating measuring and Ves safely preparing patient or human research subject No dosages
Using administrative controls to Ves prevent a medical event involving the use of unsealed No byproduct material
Using procedures to contain -I Ves spilled byproduct material safely and using proper No decontamination procedures
PAGE 2
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
447 Mitrch [xtd Tel +1 (in 592-2790 Ottilwa Onwrio jax +1 613 5()-W37 f2K 1XII Canadl wwwn1d~no1diuncon1
~ Nordion
June 292010
Dale Shippers Saint Marys Health Care 200 Jefferson St SE Grand Rapids MI 49503
Dear Mr Shippers
RE TheraSphere Y -90 Glass Microsphere Training
The individuals listed below participated in a training program at Northwestern Memorial Hospital on the use of TheraSpherereg Yttrium-90 Glass Microspheres for the treatment of hepatocellular carcinoma which was presented by MDS Nordion representatives on June 2 20 10
Mr Dale Shippers Mr Tewfik Bichay Dr Matt Tiede Dr Charles Wilkinson Dr Zdravko Skrtic Dr Gilbert Padula Mr Jim Lafarge
This vendor training program meets the requirements for training and experience specified in paragraph two of the Nuclear Regulatory Commission Guidance Microsphere Brachytherapy Sources and Devices revised September 2008
If you have any questions please do not hesitate to contact me
Yours sincerely
MDS Nordion
lj shymBurnett
Vice-President Global Sales
TBsl cc Mark Jordan MDS Nordion
NRC FORM 31lA (AUT) lamiddot20091
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMB NO 3150(1120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
Requested Authorization(s) (cheCk all that apply)
State or Territory Where licensed
Mkhlgao
Use of Y-90 microspheres in group 351000 for brachytherapy at any site
OR
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a wntten directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
bull Training and Experience including board certification must have been obtained within the 7 years preceding 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 Board Certification
a Provide a copy of the board certification
b For 35390 provide documentation on supervised clinical case experience The table 10 section 3c may be used to document this experience
c For 35396 provide documentation on classroom and laboratory training supervised work experience and supennsed clinical case experience The tables in sections 3a 3b and 3c may be used to document this experience
d Skip to and complete Part II Preceptor Attestation
2 Current 35300 35400 or 35800 Authorized User Seeking Additional Authorizalon
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
35390 35392 35394 35490 35690
b If currently authorized for a subset of clinical uses under 35300 prOVide documentation on additional required supervised case experience The table in section 3e 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 documentation 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 1 Preceptor Attestation
NRC FORM 3134 (AUT) (3middot2009) PRINTED ON RECYCLED PAPER PAGE 1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
-I 3 Training and Experience for Proposed Authorized Uur a Classroom and Laboratory Training 35390 35392 35394 35396
Clock Dates ofDescription of Training Location of Training Hours 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 Interventional Radiology pathway for Y90 microsphere training
If more than one supervising individual is necessary to document supervised framing provide multiple cOpies of this page
Supervised Work Experlenee Total Hours of 1 yearExperience
Description of Experience Location of ExperienceLicense or Dates of ConfirmMust Include Permit Number of Facility Experiencemiddot
Ordering receiving and unpacking radioactive Ves materials safely and performing Nothe related radiation surveys
Performing quality control procedures on instruments Ves used to determine the activity Noof dosages and performing checks for proper operation of survey meters
Calculating measuring and Ves safely preparing patient or human research subject No dosages
Using administrative controls to Ves prevent a medical event involving the use of unsealed No byproduct material
Using procedures to contain -I Ves spilled byproduct material safely and using proper No decontamination procedures
PAGE 2
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 31lA (AUT) lamiddot20091
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMB NO 3150(1120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
Requested Authorization(s) (cheCk all that apply)
State or Territory Where licensed
Mkhlgao
Use of Y-90 microspheres in group 351000 for brachytherapy at any site
OR
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a wntten directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
bull Training and Experience including board certification must have been obtained within the 7 years preceding 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 Board Certification
a Provide a copy of the board certification
b For 35390 provide documentation on supervised clinical case experience The table 10 section 3c may be used to document this experience
c For 35396 provide documentation on classroom and laboratory training supervised work experience and supennsed clinical case experience The tables in sections 3a 3b and 3c may be used to document this experience
d Skip to and complete Part II Preceptor Attestation
2 Current 35300 35400 or 35800 Authorized User Seeking Additional Authorizalon
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
35390 35392 35394 35490 35690
b If currently authorized for a subset of clinical uses under 35300 prOVide documentation on additional required supervised case experience The table in section 3e 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 documentation 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 1 Preceptor Attestation
NRC FORM 3134 (AUT) (3middot2009) PRINTED ON RECYCLED PAPER PAGE 1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
-I 3 Training and Experience for Proposed Authorized Uur a Classroom and Laboratory Training 35390 35392 35394 35396
Clock Dates ofDescription of Training Location of Training Hours 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 Interventional Radiology pathway for Y90 microsphere training
If more than one supervising individual is necessary to document supervised framing provide multiple cOpies of this page
Supervised Work Experlenee Total Hours of 1 yearExperience
Description of Experience Location of ExperienceLicense or Dates of ConfirmMust Include Permit Number of Facility Experiencemiddot
Ordering receiving and unpacking radioactive Ves materials safely and performing Nothe related radiation surveys
Performing quality control procedures on instruments Ves used to determine the activity Noof dosages and performing checks for proper operation of survey meters
Calculating measuring and Ves safely preparing patient or human research subject No dosages
Using administrative controls to Ves prevent a medical event involving the use of unsealed No byproduct material
Using procedures to contain -I Ves spilled byproduct material safely and using proper No decontamination procedures
PAGE 2
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
-I 3 Training and Experience for Proposed Authorized Uur a Classroom and Laboratory Training 35390 35392 35394 35396
Clock Dates ofDescription of Training Location of Training Hours 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 Interventional Radiology pathway for Y90 microsphere training
If more than one supervising individual is necessary to document supervised framing provide multiple cOpies of this page
Supervised Work Experlenee Total Hours of 1 yearExperience
Description of Experience Location of ExperienceLicense or Dates of ConfirmMust Include Permit Number of Facility Experiencemiddot
Ordering receiving and unpacking radioactive Ves materials safely and performing Nothe related radiation surveys
Performing quality control procedures on instruments Ves used to determine the activity Noof dosages and performing checks for proper operation of survey meters
Calculating measuring and Ves safely preparing patient or human research subject No dosages
Using administrative controls to Ves prevent a medical event involving the use of unsealed No byproduct material
Using procedures to contain -I Ves spilled byproduct material safely and using proper No decontamination procedures
PAGE 2
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
PAGE 3
NRC FORM 313A (AUT) (gt-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Expenence (continued)
Supervising Individual LicensePermit Number listing superVIsmg individual as an
11 shy --v1laquo( -1 __ f rl -fJJ~
8uthorized user I I -
Supervisl individual meets the requirements below or equivalent Agreement State requirements (check all that appYr
35390
~5392 35394
35396
With experience administering dosages of
Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SupervIsing Aulhonzed User must have experience in administering dosages In the same dosage category or categories as the indivIdUal requesting authOrized user status
C Supervised Clinical Case Experience If more than one supervising individual s necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y-90 TberaSpberes
(list radionuclides)
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
Klly f z ( Lf127-(iZ
Dates of Experience
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) ()middot2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Exegrience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
t) authorized user IJ shy l JtI I 11I((f-
Supervi fi001 lIcenseJPermit Number listing supervIsing Individual as an
Supervisin individual meets the requirements below or equivalent Agreement State requirements (check al that apply)
35390
35392
35394
35396
With experience administering dosages of
f Y-90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of beta-emitter or photon-emitting radionuCide with a photon energy less than 150 keY requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written directive
bullbull SUperviSing Autnonled User must have experience in administering dosages in the same dosage category or categones as the individual requesting authOrized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
Note This part must be completed by the indivjduals preceptor The preceptor does not have to be the supervising individual as long as the preceptor provides directs or verifies training and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
I attest that has satisfactorily completed the training and experience
Name of Proposed AuthorIZed User
requirements in 35390(a)(1)
OR
Training and Exegrience
-I I attest that Matthew A Tiede has satisfactorily completed one year of training
Name of Proposed Authorized User
and experience in interventionsl radiology
PAGE 4
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (3-2009)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATIESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom
Name of fgtropolIed Authonzed User
and laboratory training as required by 10 CFR 35392(c(1) and the supervised work and clinical case experience required in 35392(c)(2
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
I attest that has satisfactorily completed the 80 hours of classroom Name of Pr~d Authorized User
and laboratory training as required by 10 CFR 35394 (c)1) and the supervised work and climcal case experience required in 35394(c)(2)
--- bullbull __ -- bull Second Section
f I attest that Matthew A Tiede has satisfactorily completed the reqUired clinical case
Name of Proposed AUlhonze( User
experience required as listed below
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicunes)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Y-90 microspheres for brachytherapy at any site
~-- -------- ---- Third Section
I attest that Mattbew A Tiede has satisfactorily achieved a level of competency to
Name of Proposed Authorized User
function independently as an authorized user for
Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral Nal-131 in quantities greater than 122 gigabecquerets (33 millicurias)
Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is requIred
f Y-90 microspheres for brachytherapv at any site
PAGES
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
J NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATrESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authonzed U_
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photonmiddotemitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionucfide for which a written directive is required
OR Ioard Certification
I attest that has satisfactorily completed the board certification
Name 01 Proposed Authorized User
requirements of 35396(c) has satisfactorily completed the BO hours of classroom and laboratory training required by 10 CFR 35396 (d)(1) and the supervised work and clinical case experjence required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any betaemitter or photon-emitting radionucllde With a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directie is required __ _- __ _shyFifth Section Complete the following for preceptor attestation and signature
I meet the requirements below or equivalent Agreement State requirements as an authorized user for
35390 35392 35394 35396
I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization~
J Y-90 microspheres in group 351000 for brachytherapy at any site
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicurles)
Parenteral administration of betaamltter or photon--emitting radlonuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written dlrectNe
Name of PreccJJfK Sigo~t II 1f6~~3l wi tJJu7NLf pryL
licensePermit NumberFacility Name ~ 1- ~)lil-7--t11
Date
ilt71l Telephone Number
1 71 y ~ S-ff
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE APPROVED BY OMB NO 3150-0120
AND PRECEPTOR ATTESTATION EXPIRES (05312015)
(for uses defined under 35300) [10 CFR 35390 35392 35394 and 35396]
Name of Proposed Authorized User State or Territory Where Licensed
Matthew A Tiede Michigan
Requested Authorizations) (check al that apply)
o 35300 Use of unsealed byproduct material for which a written directive is required
OR
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY for which a written directive is required
o 35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I -- TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
o 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or ____ _-_ bull _--shy
equivalent Agreement State requirements (check all that apply)
35390 035392 035394 35490 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 documentation 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
NRC FORM 313A (AUT) (05middot2012) PAGE 1
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 3i3A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
o 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396 -----~---- ~---~-~~~---~---~~~--~~
Description 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
Location of Training
h-o Health Grand Rapids MI and St Marys Health Care Grand Rapids MI
I Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and St Marys bullHealth Care Grand Rapids MI
Spectrum Health Grand Rapids MI and 8t Marys Health Care Grand Rapids MI
Spectrum Health Grand Rapids MI and st Marys Health Care Grand Rapids MI
Total Hours of Training
b Supervised Work Experience 35390 035392
5
Clock Hours
- 62008
62004 - 62008
35396 If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
Supervised Work Experience Hours of Experience 700
Description of Experienjce Location of ExperienceLicense or - C nfi~---r-Dates of I bull Must Include Permit Number of Facility 0 I I Experience ~ ~~--~-~- --shy --shy --~---~-- I----~ Ordering receiving and I I Iunpacking radioactive materials St Mary sHealth Care Grand RapIds MI 0 yes~ ~2004 - 62008 safely and performing the 0 No related radiationsurve~__I___ ______ __ __ _ _ __ I
Performing quality control I
procedures on instruments 81 Mary sHealth Care Grand RapIds MI 0 Yes 612004 - 62008 I
used to determine the activity lof dosages and performing 0 No checks for proper operation of
meters
ICalculating measuring and i 81 Marys Health Care Grand Rapids MI 0 Isafely preparing patient or i human research subject 0 dosages
---shy_---shy -----shy _-__-shy _---shy - --~--~--+----~--+----~-------
lUSing adminis~rative controls to i S1 Marys Health Care Grand Rapids MI 0 Yes prevent a medical event linvolving the use of unsealed 0 No I ibyproduct material i
IU~ing p~~cedures t co~tai~~aryS H~alth ca~ Grand aPids-~-I---middotmiddotmiddotmiddotmiddot----1middot-0 ~~04 _~20~~ilspilled byproduct matenal bull I
l~~t~i~ii~~ ~~~~~u~es__L_~ ______ __ ~_ ~__ __~_Lc Ndeg __L___ J NRC FORM 313A (AUT) (05-2012) PAGE 2
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
I
Dates of Experience
-----------+-- -------1
NRC FORM 313A (AUT) US NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual LicensePermit Number listing supervising individual as an authorized user
Chad R Williams MD 21-01078-01 ~ - ~
Supervising individual meets the requirements below or equivalent Agreement State requirements (check aI that apply)
~ 35390 With experience administering dosages of
~ 35392 ~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122
035394 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) ~ 35396
~Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
i_ _~ _ _ _~_ _ ___ ____ __
I Number of Cases l tmiddot f E fl pt1
Description of Experience Involving persona~ ocalon 0 xpenence Ic~nse or erml Participation Number of FacIlity
~----- - --~~ __-_- shyadministration of sodium 11 Spectrum Health Grand Rapids MI and St
liodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities less than ior equal to 122 gigabecquerels (33 millicuries) --~~-~------t-- _ Oral administration of sodium 13 Spectrum Health Grand Rapids MI and St jiodide 1-131 requiring a written Marys Health Care Grand Rapids MI directive in quantities greater Ithan 122 gigabecquerels (33 millicuries)
Parenteral administration of Iany beta-emitter or photon-emitting radionuclide lwith a photon energy less than 1150 keY for wh ich a written jdirective is required - ~- ----- - ~-+--Parnteral~d~inistr~tion of any I-middotmiddotmiddotmiddot~ - -shylother radionuclide for which a
(List radionuclides)
ritten directive is
NRC FORM 313A (AUT) (05-2012) PAGE 3
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Isupervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that appy) ~ ~ w w ~ __ bullbull ___ _
035390 With experience administering dosages of
035392 0 Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
035394
035396 o Oral Nal-131 in quantities greater than 122 gigabecquerels 33 millicuries
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
bullbull Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
[d Provide completed Part II Preceptor Attestation
PAR11I- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)1)
OR
Training and Experience
D I attest that has satisfactorily completed the 700 hours of training ----shy
Name of Proposed Authorized User
and experience including a minimum of 200 hours of classroom and laboratory training as required by 10 CFR 35390 (b)(1)
NRC FORM 313A (AUT) (05-2012) PAGE 4
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) U_S NUCLEAR REGULATORY COMMISSION (05-2012)
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom --~~~~~-C~~--~~~~--
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
o I attest that Matthew A Tiede has satisfactorily completed the 80 hours of classroom -~-N-am-e-of~P~~-po-sedAu~t-ho-riz-~~Us-er--
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
_----------------_ _------- - _---_ _--shySecond Section
o I attest that Matthew A Tiede has satisfactorily completed the required clinical case ~-~-~~--~~-~~--~
Name of P~posed Authoriz~ User
experience required in 35390(b)(1 )(ii)G listed below
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
_-------------------_ - _-- --__------ ---------shyThird Section
o I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ~~ --~-~-~~ -~~~
Name of Proposed Authorized User
function independently as an authorized user for
o Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keY requiring a written directive is required
o Parenteral administration of any other radionuclide requiring a written directive
NRC FORM 313A (AUT) (05-2012) PAGES
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) (05-2012)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
I attest that is an authorized user under 10 CFR 35490 or 35690
Name of Proposed Authorized User
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 work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
OR Board Certification
D I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
D Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radionuclide for which a written directive is required
------shy _-----__---_ __ _ _ _-_ Fifth Section Complete the following for preceptor attestation and signature
~ I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
~ Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
Name of Preceptor
Chad R Williams MD signltf~ 00 I ril
~--------
Telephone Number
(616) 685-6217
Date
1a-19-2shyLicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI 49503
NRC FORM 313A(AUT) (05-2012) PAGES
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 3i3A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (for uses defined under 35300)
[10 CFR 35390 35392 35394 and 35396]
APPROVED BY OMS NO 3150middot0120 EXPIRES 31312012
Name of Proposed Authorized User
Matthew A Tiede
State or Territory Where Licensed
Michigan
Requested Authorization(s) (check al that apply)
~ Use of Y -90 microspheres in group 351000 for brachytherapy at any site
OR
o 35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
35300 Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
o 35300 Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
35300 Parenteral administration of any other radionuclide for which a written directive is required
PART I bullbull TRAINING AND EXPERIENCE (Select one of the three methods below)
Training and Experience including board certification must have been obtained within the 7 years preceding 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
o 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 used to document this experience
c For 35396 provide documentation 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
d Skip to and complete Part II Preceptor Attestation
10 2 Current 35300 35400 or 35600 Authorized User Seeking Additional Authorization
a Authorized User on Materials License under the requirements below or equivalent Agreement State requirements (check all that apply)
035390 [J 35392 35394 35490 35690
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 It currently authorized under 35490 or 35690 and requesting authorization tor35396 provide documentation 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
NRC FORM 313A (AUT) (3-2009) PRINTED ON RECYCLED PAPER PAGEl
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTAnON (continued)
~ 3 Training and Experience for Proposed Authorized User
a Classroom and Laboratory Training 0 35390 0 35392 035394 035396
Description of Training
Radiation physics and instrumentation
Radiation protection
Mathematics pertaining to the use and measurement of rad ioactivity
Chemistry of byproduct material for medical use
Radiation biology
Location of Training
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicago IL
Spectrum Health Grand Rapids MI St Marys Health Care Grand Rapids MI Northwestern U Chicag
Total Hours of Training
53
11
7
6
11
88
Clock Hours
Dates of Training
612004 - 612008 612010
612004 - 62008 62010
612004 - 612008 612010
612004 - 612008 612010
1
612004 - 62008 612010
b Supervised Work Experience ~ Interventional Radiology pathway for Y -90 microsphere training
If more than one supervising individual is necessary to document supervised training provide multiple copies of this page
ISupervised Work Experience
I
Description of Experience Must Include
ITotal Hours ofIExperience
Location of ExperienceLicense or Permit Number of Facility
middotOrdering receiving and St Marys Health Care Grand Rapids MI
I
unpacking radioactive materials safely and performing the related radiation surveys
bull Performing quality control St Marys Health Care Grand Rapids MI procedures on instruments
bull used to determine the activity middotof dosages and performing checks for proper operation of survey meters
Calculating measuring and Sf Marys Health Care Grand Rapids MI safely preparing patient or human research subject dosages
Using administrative controls to St Marys Health Care GraDd Rapids MI prevent a medical event involving the use of unsealed byproduct material
Using procedures to contain st Marys Health Care Grand Rapids MI spilled byproduct material safely and using proper decontamination procedures
1 year
Confirm
~Yes
ONo
~Yes
ONo
~Yes
No
~Yes
No
~Yes
[J No
700
Dates of Experience
612004 - 612008
612004 - 612008
612004 - 612008
62004 - 62008
62004 - 612008
PAGE 2
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
b Supervised Work Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
--shy _ - -shy - - -shy -shy - -shy -- -shy - - -shy -shy - --_- ---- --- ---- -- - ----- - -shy - - --- -------- - -shy -shy --_ ---_ _
Supervising individual meets the requirements below or equivalent Agreement State requirements (check all that apply)
~ 35390
~ 35392
~ 35394
~ 35396
With experience administering dosages of
~ Y-90 microspheres
~ Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
~ Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directwe
bullbull Supervising Authorized User must have experience in administering dosages in th e same dosage category or categories as the individual requesting authorized user status
c Supervised Clinical Case Experience If more than one supervising individual is necessary to document supervised work experience provide multiple copies of this page
Description of Experience
Oral administration of sodium iodide 1-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
Oral administration of sodium iodide 1-131 requiring a written directive in quantities greater than 122 gigabecquerels (33 millicuries)
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral administration of any other radionuclide for which a written directive is required
Y -90 TheraSpheres
(list radionuclides)
4
Number of Cases Involving Personal
Participation
Location of ExperienceLicense or Permit Number of Facility
St Marys Health Care Grand Rapids MI
Dates of Experience
Mar 26 2012 May 4 2012 Jan 42012
PAGE 3
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3 Training and Experience for Proposed Authorized User (continued)
c Supervised Clinical Case Experience (continued)
Supervising Individual
Chad R Williams MD
LicensePermit Number listing supervising individual as an authorized user
21-01078-01
Supervising indiv[duai meetsthe requirements below or equivalent Agreement state requiremeritil (cheCk ali that apply)middot
ra 35390
D 35392
D 35394
D 35396
With experience administering dosages of
~ Y -90 microspheres
Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries) Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
Parenteral administration of any other radionuclide requiring a written direcle
Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status
d Provide completed Part II Preceptor Attestation
PART 11- PRECEPTOR ATTESTATION
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 and 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 position sought and not attesting to the individuals general clinical competency
First Section Check one of the following for each requested authorization
For 35390
Board Certification
D I attest that has satisfactorily completed the training and experience
Name of Proposed Authorized User
requirements in 35390(a)(1)
OR
Training and Experience
o I attest that Matthew A Tiede has satisfactorily completed one year of training-__shy--------shy
Name of Proposed Authorized User
and experience in interventional radiology
PAGE 4
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Preceptor Attestation (continued)
First Section (continued)
For 35392 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35392(c)(1) and the supervised work and clinical case experience required in 35392(c)(2)
For 35394 (Identical Attestation Statement Regardless of Training and Experience Pathway)
D I attest that has satisfactorily completed the 80 hours of classroom
Name of Proposed Authorized User
and laboratory training as required by 10 CFR 35394 (c)(1) and the supervised work and clinical case experience required in 35394(c)(2)
~-------shy - ---------- --------shy shy---_shySecond Section
~ I attest that Matthew A Tiede has satisfactorily completed the required clinical case ----~--~--~~--~-----shy
Name of Proposed Authorized User
experience required as listed below
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
D Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
_----- - __ bullbull _---_ Third Section
~ I attest that Matthew A Tiede has satisfactorily achieved a level of competency to ----~--~--~~~~~---shyName of Proposed Authorized User
function independently as an authorized user for
D Oral Nal-131 requiring a written directive in quantities less than or equal to 122 gigabecquerels (33 millicuries)
=J Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
D Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Y -90 microspheres for brachytherapy at any site
PAGES
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
)
NRC FORM 313A (AUT) (3-2009)
US NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Fourth Section
For 35396
Current 35490 or 35690 authorized user
D I attest that Name of Proposed Authorized User
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 wak and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
D Parenteral administration of any other radio nuclide for which a written directive is required
OR Board Certification
I attest that has satisfactorily completed the board certification
Name of Proposed 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 supervised work and clinical case experience required by 35396(d)(2) and has achieved a level of competency sufficient to function independently as an authorized user for
Parenteral administration of any beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Parenteral adminstration of any other radionuclide for which a written directive is required
~---- ---- ----- --- shy-----shy -- shyFifth Section Complete the following for preceptor attestation and signature
o I meet the requirements below or equivalent Agreement State requirements as an authorized user for
~ 35390 ~ 35392 ~ 35394 ~ 35396
~ I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization
o Y -90 microspheres in group 351000 for brachytherapy at any site
o Oral Nal-131 in quantities greater than 122 gigabecquerels (33 millicuries)
o Parenteral administration of beta-emitter or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive is required
~ Parenteral administration of any other radionuclide requiring a written directive
0 A 11 A rR Name of Preceptor
I Si9rfitUrlj 1Telephone Number
iJ--l lLVC 1(616) 685-6217Chad R Williams MD
LicensePermit NumberFacility Name
21-01078-01 Saint Marys Health Care Grand Rapids MI49503 PAGE 6
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352
us POSTAGEraquo PITNEY BOWES200 Jefferson Avenu-e SE
Grand Eapids Michigan 49503 Tb SAINT MARYS (I~-~ HEALTH CARE ~--
ZIP 49503 $ 002 50deg 02 1VV bull 0001361605DEC 20 2012
)EPARTMENT OF RADIOLOGY
~
MATERIALS LICENSING BRANCH US NUCLEAR REGULATORY COMMISSION
REGION III
SUITE 210 2443 WARRENVILLE ROAD LISLE IL 60532-4352