.

_ _ - _ _ _ _ .

M M[5E[MMMMGECMMMMMMMMMMMMMMMMME Mp|-} p PAm| NRC FORM 374

U.S. NUCLEkR REOULATORY COMMl!SIONPA O

y pp.es)

MATERIALS LICENSE gy

| || Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, y

| Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,39,40 and 70, and in reliance on statements and representations heretofore p

( made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct. source, and special | )I nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material I

I to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions

specified in section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear y jy

g Regulatory Commission now or hereafter in effect and to any conditions specified below, ghNb I1 .,II Licensee

i 1. In accordance with letter dated I

l I September 15, 1994 |'

|3. License numberl- Rcchester Diagnostic 21-26287-01 is amended in I

q & Specialty Center its entirety to read as follows: 1

I Ir II 2. P.O. Box 82207

~ .b- )4AXP tipnfate Aoril 30. 1996 | |;.- \ " f| Rochester, MI 483085. Docket or |y V Reference No. i030-32081 1i s

7. Chemical and/or physical . Maximum amount that licensee |*

@p.)I 6. Byproduct, source, and/or

form may possess at any one time II special nuclear material g$ '

/ /yunder thislicense

|'

.

4 y &. p ,

..

|-g % .m m|E - Y I Ah Any .- [ A G' As needed !

.

U I1 A. Any byproduct "

I material identified 5 O 'radioptiEr'maceyf ' Ia

{ $ N dentff'ie'd i'n A s O i| in10CFR35.10g /i 4 CF. 5dD0_ ,,,/ W |.

,

| B. Any byproduct 0 kg hj| B $ needed ImaterialidentiiMd ,7

alhj'g7, Ii eu

. kodQ@NCFI

w) a ( ing xenon % b,

)[ f C ;' #

y%f, L 133,T h g [Q |

gg

i

i| /) gI1 9. Authorized Use: 4 4 ,L g 7g Il 9|1, A. Medical use described in 10 CFR 35.f00. A

| 1

B. Medical use described in 10 CFR 35.200 (excluding xenon-133) 1iI II /| CONDITIONS

| 10. Locations of Use: 543 N. Main, Rochester, Michigan; 610 Main Street, Rochester, lI Michigan; and 53960 Van Dyke, Utica, Michigan. ;'

II 11. A. Radiation Safety Officer: Lawrence Wayburn, M.D.' )

| B. Alternate Radiation Safety Officer: Deborah Arellano, R.T. The alternate RSOwill act only in the absence of the RSO. |i

{6 (M) a % f [300123 '

ll 9501310322 9501051 PDR ADOCK 03032001& C PDR I-~ ' - '

' '- ' ' ''-

_ _ _ _ _ _ _ - _ _ _ _ . _-

i nwwwwwwwwwwwwwwwwwwwwwwwwwwOwwwwwwwwwwwGwx$'N FORM 370A U.S. NUCLEAR RE8ULATQRY COMMISSION PaGE - 2 OF p PAGES g

*

,

License Rumber, ga

y .11-26287-01 Eg MATERI ALS LICENSE Docket or Reference Numter gg' SUPPLEMENTARY SHEET 030-32081 E

N E

s Amendment No. 04 E

W E

6 E

B E

a Eg 12. Licensed material listed in Item 6 above is only authorized for use by, or under the Eg supervision of, the following individuals for the materials and uses indicated: Np - |u Authorized Users i Material and Use ih Eg Lawrence Wayburn, M.D. 10 CFR 35.100 and 35.200 (excluding xenon-133). gg gg 13. The Radiation Safety Officer, Dr. Lawrence-Wayburn or his alternate, Deborah gg Arellano, will dedicate a minimum.of two (2)' hours .on-site time per week performing Wg the duties of the Radiation. Safety Officer as described in 10 CFR Part 35, for each gg location of use identified'in License Condition Number 10. The licensee shall gg maintain records documenting on-site time dedicated to''each location of use for gg review during inspection. Q Wsg . , , yg 14. The licensee shall not vacate or release any location of use whose address is gg identified in Condition Number 10. for unrestricted .use, with~out first submitting a gg close-out survey to the NRC;for review. j g

#

,.-A .n gy : . t

'

.

15. The licensee shall maintain records of information important'to safe and effective ggdecommissioningtat 543

N.,, Main,0(lochest'ery(ichigan' per the provisions of 10 CFRa

~ g30.35(g) until thi,s license TsYterniinated_bf th'egCommiss' ion. A g

'

| Except as specifically)p& . - T(h]e|r| wise fi ('this IIc;y'$%tt % W f b g

n

16. rovided o ense, the licensee shall g;

conduct its prograni in acc6rdanc6fnithjthe! tatements, representations, and gprocedures contained in theidocuine'ntshincllidingiany enclo'su'res, listed below, yexcept for minor changes in the medical?usexradiation safety procedures as provided gin 10 CFR 35.31. The Nuclear Regulatopy Coinmission's regulations shall govern gunlessthestatementsprepresentations,")andproceduressinthelicensee'sapplicationg

;y; and correspondence are more restrictive than the reijulations. g- ,-

~

ag

ApplicationdatedFebruary2k1991(jith~a"ttachments);and gA.

B. Letters dated April 1, 1991, April 4, 1991 and September 15, 1994.. N

$ H

E EN E

R Nn E '

NFOR THE U.S. NUCLEAR REGULATORY COMMISSION

W

Date h,b By -( 'Materials Licensing Sectiongegion III

(~O)dW |"

D %s y g.

g .W. , g I

%mmmmmmmmmmmmmmmmmmmmmmmmmmmMmmmmMMMmmmmmmmMMMM j

Prmied on secycled paper- 4 t

p ,o 3,g ,

,. ,

!.

JAN 0 61995

i

|

,

Rochester Diagnostic &Specialty Center

ATTN: Dr. Pierre AtallahMedical Director-Owner i

P.O. Box 82207Rochester, MI 48308

Dear Dr. Atallah:

Enclosed is Amendment No. 04 to your NRC Material License No. 21-26287-01 inaccordance with your request.

Please review the enclosed document carefully and be sure that you understand -

all conditions. If there are any errors or questions, please notify the U.S.Nuclear Regulatory Commission, Region III office at (708) 829-9887 so that we -

can provide appropriate corrections and answers.

A. This also refers to the telecon on December 22, 1994, between ColleenCasey and Deborah Arellano, regarding the following issues: '

1. It was agreed that the alternate Radiation Safety Officer (ARS0)will act only in the absence of the RSO.

2. The licensee confirmed that all radiation safety proceduresin place at Rochester Diagnostic and Specialty Center will befollowed at the two locations merged into this license upontermination of the Atallah Heart Center license. Said mergerand termination will take place concurrently.

,

3. It was agreed that, due to fees consideration, License ConditionNo.13 on Amendment No. 03, which authorized depleted uranium t

shielding in generators, would be removed at this time. It isunderstood that this change will not affect the licensee's abilityto obtain lead-shielded generators.

B. Please be advised that your license expires at the end of the day, inthe month, and year stated in the license. Unless your license has beenterminated, you must conduct your program involving byproduct materialsin accordance with the conditions of your NRC license, representationsmade in your license application, and NRC regulations. In particular,note that you must:

y YS_-_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ______

p . y-

,

#-.

j.

!

!Rochester Diagnostic & -2- JAN 0 61995 |Specialty Center

i

1. Operate in accordance with NRC regulations 10 CFR Part 19, !" Notices, Instructions and Reports to Workers; Inspections," 10 ;

CFR Part 20, " Standards for Protection Against Radiation," and. {other applicable regulations. i

2. Notify NRC, in writing, within 30 days:'

a. When an authorized user or Radiation Safety Officerpermanently discontinues performance of duties under thelicense or has a name change; or

b. When the licensee's mailing address changes (no fee isrequired if the location of byproduct material remains'the jsame). !

:i3. In accordance with 10 CFR 30.36(b) and/or license condition, inotify NRC, promptly, in writing, and request termination of the ;

license when you decide to terminate all activities involving imaterials authorized under the license. !

I

4. Request and obtain a license amendment before you: |a. Receive or use byproduct material for a clinical procedure !

permitted under Part 35 but not permitted by your license :

issued pursuant to this Part;i

b. Permit anyone, except a visiting authorized user described,

in 10 CFR 35.27, to work as an authorized user under the i

license,;

c. Change Radiation Safety Officers; ;

d. Order byproduct material in excess of the amount, or I

radionuclide, or form different than authorized on the,

license; '

e. Add or change the areas of use or address or addresses of,

use identified in the license application or on the license;or j

f. Change ownership of your organization.

5. Submit a complete renewal application with proper fee or :

termination request at least 30 days before the expiration date ofyour license. You will receive a reminder notice approximately 90 |days before the' expiration date. Possession of byproduct. material

,

,

f

6

1

, .s - . . , . . -- . . - , .. - ,- .

7.. .- . --,

4

..

f*

i

!Rochester Diagnostic & -3- JAN 0 61995 !,

Specialty Center||

i

after your license expires M a violation of NRC regulations. A .jlicense will not normally be renewed, except on a case-by-casebasis, in instances where licensed material has never beenposse;ssed or used.

>

In addition, please note that NRC Form 313 requires the applicant, by his/her .isignature, to verify that the applicant understands that all statements !contained in the application are true and correct to the best of the |applicant's knowledge. The signatory for the application should be the ilicensee or certifying official rather than a consultant. !

You will be periodically inspected by NRC. Failure to conduct your program inaccordance with NRC regulations, license conditions, and representations made

,

in your license application and supplemental correspondence with NRC will |result in enforcement action against you. This could include issuance of a-|notice of violation, or imposition of a civil penalty, or an order suspending, ;

modifying or revoking your license as specified in the General Policy and . .!Procedures for NRC Enforcement Actions, 10 CFR Part 2, Appendix C. Since- !

serious consequences to employees and the public can result from failure to }comply with NRC requirements, prompt and vigorous enforcement action will~be itaken when dealing with licensees who do not achieve the necessary meticulous - Iattention to detail and the high standard of compliance which NRC expects ofits licensees. .

Sincerely, ||

|.

Original Signed By i

Colleen C. Casey -

Nuclear Materials Licensing Section |

License No.: 21-26287-01 !Docket No.: 030-32081 i

Enclosures: 1. NRC Form 313 |2. Amendment No. 04 !

l!

f i

!

DOCUMENT NAME: M:\03032081.CL4 |v % . .e me m w.:c.c e.n.a nu.na : c. . m a r-u. ;0FFICE DRSS/RIII IN | | | | ;

NAME CCCASEY:jawCCh--DATE 14/rf/9Af i

0FFICIAL RECORD COPY j

|!

!

[

!

- O ;:'

' *

.. .. ..

i |W (FORLFhYUSE)

^

: INFORMATION FROM LTSOi BETWEEN:! --------------------

1 i LICENSE FEE MANAGEMENT BRANCH, ARM : PROGRAM CODE: 02200I >

n | AND : STATUS CODE: 0|

v r REGIONAL LICENSING SECTIONS : FEE CATECORY: 7CEXP. DATE: 19960430FEE COMMENTS:.,

i DECOM FIN ASSUR~REGDTT"~~~~~~O ;. ::::::::::::::::::::::::::::::::::::::I

! LICENSE FEE TRANSMITTAL

O ! A. REGION

I 1. APPLICATION ATTACHEDI APPLICANT / LICENSEE ROCHESTER DIAGNOSTIC & SPECIALITYO' RECEIVED DATE: 941007

DOCKET NO: 3032081CONTROL NO. 397668

O |' LICENSE NO.: 21-26287-01ACTION TYPE: AMENDMENT

2. FEE ATTACHED

5ge0000AMOUNT:0. CHECx NO.: _ap t3-!

3. COMMENTS ,

SicNED jf M _ M m /IO,DATE ___[2ff f-

~ ~~~'

B.LICENSEFEEMANAGEMENTERANCH(CHECKWHENMILESTONE03ISETERED/g/)-

1. FEE CATECORY AND AMOUNT: OO G_________________,__________

APPLICATION MAY EE PROCESSED FOR: ' , -2. CORRECT FEE PAID./ rO AMEuDMENT <;''~~~~~~~~~~~~~~

RENEWALI

| LICENSE ~ :~"~ ~~ :~~ ~6I O 3. OTHER g__________________________________

''EDQ g_______ _ g ,,P f__._____________________._ _ ___ _. ___ .__ u

o RECEIVED

O 0C121 199'ii REGION III

O,t

!O

x _ __ ___

r 7"

' m4 -.g. -

.- y..

,

ROCHESTER,

g DIAGNOSTIC& SPECIALTY

CENTER

September 15, 1994

Colleen CaseyNuclear Regulatory CommissionRegion IIIMaterials Licensing Section801 Warrenville RoadLisle, IL. 60532-4351

Dear Ms. Casey:

This letter is in response to a telephone conversation between ourconsultant, Ray A. Carlson, M.S., and yourself concerning the ByproductMaterial license for the Atallah Heart Center (21-25968-01) and the RochesterDiagnostic and Specialty Center (21-26287-01).

1. Please amend the Rochester Diagnostic and Specialty Center(21-26287-01) to add the location of use the Atallah HeartCenter (21-25968-01), 610 Main Street, Rochester, Michiganand 53960 Van Dyke, Utica, Michigan.

2. Withdraw the renewal application, which is pending and notreviewed for the Atallah Heart Center.

All locations are owned by Dr. Atallah and have Dr. Wayburn as the authorizeduser and Radiation Safety Officer. In addition, the alternate RadiationSafety Officer will be Deborah Arellano, R.T. (ref: 21-25968-01).The control number for the renewal is 396293. As was requested by telephone,the renewal action is to be stopped unreviewed and it is requested that thefee of $1400.00 be returned.

Enclosed is a check for $500.00 for the amendment fee.

If there are any questions, please contact Ray A. Carlson, M.S., our physicsconsultant.

Sinc ely,,. , --- . .- - . . - . . - . ,

- - ~ . - - - - - . -

- ~~-~p . . . . , .

n afj M ~ ~~~~

]-~RECEIVED. Pierre C. Atallah, M.D.,

Medical Director / Owner g p 3 Gp f _-

-

p 3 c3

. . . . . _ . . , _ . , , , ._?,r

- - _ . . . . . -

,

IIIVLit M)t'Alti: / 543 N. MAIN ST. Il'.O. ILOX M2207 / HOCill;STElt. MI 4M30M / TEL. (M10) 656-3100 / I%X (M10) 656 3152

3976G8 )

_ ._. _.

Im. & . '* ' w |; ..

i

l

From: Colleen C. Casey (CCC)To: IPDDate: Friday, July 22, 1994 11:43 amSubject: Atallah/ Rochester Update

Just so you and your successor know- licensee's consultant called me this,

morning and they won't be able to submit the paperwork for the merger ;

amendment and termination request until after August 8, because ofconsultant's vacation. We will look for this after the 8th. Thanks. ;

.-

4{uffy'

.

h,smm_=,

Nr &c Afy$*' "..

))fw;% cG%bbw ~f k7Vi~~ ;m$Ex L ANAym.

,

). 4 . .

'

/aperi 97)u.y cr$suJ%aris nlotafMt! \

'

7

,,41.$A4Lif/LA.AblM '

de d 1 8 (< #ft4 5 b^ N"*$f '

c|d|A$ld"K'+A""'Y NN ..'

>

g aac h</d ( M a d 06 ~ ;*

J{u;;(w eks/w p ad m>M .

O p,uem f f ,) ' < bu -[f un N ,

[x|swy.||ta41SN&t. .

Thnh :'

dkg {L t|L J : al M W Ig(s y. 21 25e217- of .

~ ,

:

\. 7 '

397608_ _ _ _ _ _ _ _ _ _ - - - _ - - - _ _ _ - - _ _ _ _ _