24
Radiology 200 Jefferson, SE Grand Rapids, MI 49503 g HEALTH CARE Phone: 616.685,6744, FAX: 616.685.3066 www.smhealthcare.org "r1j j SAINT MARY'S December 19, 2012 Materials Licensing Branch U.S. 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, M.D. as an Authorized User for Y-90 microspheres in group 35.1000 for brachytherapy at any site. Training and Experience for Y-90 as listed in Microsphere Brachytherapy Sources and Devices REVISED JUNE 2012 Training requirements in A3.ii: 80 hours of classroom and laboratory training is documented in the Form 313A signed by Dr. Chad Williams. Work experience under the supervision of an AU for Y-90 microspheres, as required in A3.iii: This experience is documented by both Dr. Chad Williams and Dr. Richard N. Joynch (21-04127-02). Training in the operation of the delivery system, safety procedures, and clinical use for each type of Y- 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, M.D. as an Authorized User for 35.392 Dr. Tiede's ABR certificate is attached to fulfill the requirements as listed in 35.390 a. Add Matthew A. Tiede, M.D. as an Authorized User for 35.394 Dr. Tiede's 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 Some of Dr. Tiede's training and experience is not within the last 7 years. Documentation is attached to show recent involvement in the areas of use requested. Nordion TheraSphere, Y-90 Glass Microsphere Training, Jun. 2, 2010 Society of Interventional Radiology's Y90: Are you ready course, Feb. 10-13,2011 (26 hours) Nordion Advanced Users Meeting, Feb. 24, 2012 (8 hours) Sincerely, Dale Schippers I Earl Monks r Radiation Safety Officer Director of Radiology RECEJV£D DEC 2 1e1.2 NRC letter add Drs Tiede &Rapoport Nov2012.doc

r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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

Page 2: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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

Page 3: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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

Page 4: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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

Page 5: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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

Page 6: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 7: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 8: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 9: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 10: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 11: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 12: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 13: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 14: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 15: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 16: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 17: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 18: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 19: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 20: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 21: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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 22: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

)

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 23: r1jg j SAINT MARY'S 200 Jefferson, SE HEALTH CARE · 2019. 12. 17. · 2443 Warrenville Road, Suite 210 Lisle, Illinois 60532-4352 RE: Amendment of License: 21-01078-01 . To whom

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