ML20204C678

License 21-16254-01 for Iz Phillips,Ja Dalessandro, Radiology & Nuclear Medicine,Authorizing Use of Listed Licensed Matl for Production of Tc99m Pertechnetate & Lung, Liver & Spleen,Pancreas,Bone,Kidney & Brain Imaging

ML20204C678
Person / Time
Issue date:	09/13/1974
From:	Bowyer J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20204C625	List: ML20204C678
References
21-16254-01, 21-16254-1, 80714, NUDOCS 8607310284
Download: ML20204C678 (9)

Text

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BYPRODUCT MATERIAL: LICENSE gI%.,

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.m Pursuant.to the Atomic Energy. Actf'of 1954 and Title 10; Code-of fed ral Regulations, Chapter.1/Per:630,22,33,

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34, andM, and in reliance on. stat 9, men!'sjnd represpntetions }1eretolognale byge: licensee, 'a licensp;isjhpreby. issued and,'ynp9tl, byproduct fnat :ial, listed,belp and to use authorizing the I;censee to receive, acquire l qg possess,- trangfep'at d below.Thiiliceme'shall b 9

such byproduct material for the pu'rpose(s) an.d at5e place (s) design conditions specified in Section 183 al the Ator'nic Energy Act pf 1954 as'aspe$ded[and issubject to all aphlicable rules, reg-1!

ulationi,'and ' rders of the ; Atomic' Energy Cornmissio'nlow"or heieaftdr iN pliedMdio"a'riy ~conditionsippcifisd below. -

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7. Chemical. and[or physicaligg8l)Aa4 m,um amqun.ti[ofgadioac-i

,.,;,,,mff,y;jp;g,jgtiv,ity which licensep,may: l f orfn...;,,,,,.

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,.,y wg;q.;.y:..g. possess at any prio time i (,,p.g. s o...

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A. ~Any ra'dio-a i.f 6. :d!@y pitqA;l As necessaryl p$g,.7

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material listed

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in Group 11 of

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H. Holybdanum 99 B. ;Molybdenua 99 / ',~ ' '. '@.P.y j B Q'..1Q00 millicup$os ~,

{ Technetium 99m GeneratorsE,< C d.

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', ~ (E.'iR. Squibb and Sons Model4 J... S './. W 'R

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through 012.and 100fthrough 10,6;[

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' Cambridge Nuclear Corp. Model.#M 3 N.7.s[?...g [..

NE Ho.'CN-4291;andAmersham/ Sear;lml*

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.. "Corpi Model Nos.~ GTC-50, GTC-100,

' GTC.200, GTC 300 p. and GTC-400)4

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Ccnditions numberea printed on the reverse side'of this page shall' apply to'..

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1x4 this license.'

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.tained in application received August 26', 1974~ ~Latter'receiveu aups.mauer b.f " '

and 1974, signed by Dr. John A. D' Alessandro.

For the U. S. Atomic Ener Commission SEP I 31974 Hacerials Branch Date g

Dir.ctorate of Lic.nsmg Washington. D. C. 20s48 8607310284 860530 REG 3 LIC30 CONTROL NO. 6' 0 '< 1 <1 12-18991-01 PDR

U. S. ATOMIC ENERGY COMMISSIO[

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BYPRODUCT MATERIAli LICENSE

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• Supplementary Sheet ' - '. *;.j.-.O.

'ontimacd From Page 1

.,d ' }.I.icense N;;QJ21-16254-01

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Byproduct material

7., Chemical and/or physical form.

l 8pMaximum amount of radio activity which (element and mass number) g.',.,x, licensee may possess pt. any one time

.C, Technatium 99m sC.. Labeled albumin '

? SMD100 minicuriesN microspheres. (human) :.,..ihW..~i::.

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prepared by. the '

licensea using..i,

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D. Technetium 99m

.D. Sulfur Conoid it.gi4;fWgD2/100. minicuries;/.

(Prepared by. the..

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.3 licensee using ther,V:M.yg. YAM s ;.v.n Squibb,. Abbott 7768,M G.0,$ 6,

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.F. TechnaCated~. (Tc99m)p hhs ;;;F 0100. minicuries -

Aggregated Albumin

" d 3 ~'i (Human) prepared by"<* ' " M.Y the licensee using i ? g ': $ %

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the w,m nckrodt,.i V ;.f i gf.

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Squibb, or Medi-Physicg.'.i"i4f.1 O

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kit

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G. Technetium 99m G. Labeled Polyphosphatas. 3 YjGd100 millicuriosi' Prepared by the :licanagei1 e di ~.

....be.

using the NEN or Diagnostic f:,.4 Isotopes kit

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.H. Technetium 99m

.H. Irca-escorbate. eak QUBJ,190 minicurid diethylenetriamina n,;>.:. uw

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Pentancetic acid @;'.l 46 complex (prepared'

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by.the licenses a ;,,d d w i' :..? '

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usin kit)g the Squibb.

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,.,..g.gy,g,tl3g,3, 7,,,,. g, I. Technetium 99m

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DIPA (Sn) prepated.K L 'M

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tained in application received August 26, 1974,' and latter received September 12, 1974 - signed by. Dr. John. A. D' Alessandro.

For the U. S. Atomic Ener Commission i

SEP / 31974

~

' Materiala Branch Date by Directorate of Licensing Washington D.C.20548 CONTROL NO. 8()714

1 rop gm.i U. S. ATOMIC ENERGY COMMISSION Paga 3 or 3 Pages i o e ra 'n o -

BYPRODUCT MATERIAL LICENSE

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Supplementary Sheet g

9.. Authorized use I

l A. Any diagnostic proceduru listed in Group II of Schedule A, Section 35.100 of Title 10, Code of Federni Regulations.

.B. Production of Technetium 99m pertechnetate.

C. Lung imaging.

D. Liver and spleen imaging.

E. Pancreas imaging.

.F. Lung imaging.

.G. Bonc. imaging.

H. Kidney imaging.

I. Kidney imaging, kidney functim, and brain 4==ging.

CONDITIONS 1

10. The licensee shall comply with the provisions of Iltle 10, Chapter 1,. Code of Federal Regulations, Part 19,' " Notices, Instructions and Esports to Workers; Inspections" and Part 20. " Standards for Protection Against Radiation."

11.. Byproduct material shall be used by Irwin Z. Phillips,- D.O., or John A.

D'Alessandro, D.O.

12. Biological products labeled with radionuclides or kits used to prepare such products shall be procured from a supplier who holds an unsuspended or un t

revoked license issued by the Secretary of the Department of Health, Education, and Welfare to propagate, manuf acture, prepare, label, or distribute the products. The labeled biological products shall be used only for the medical indications covered by the supplier's Department of Health, Education, and Welfare license.

13. The licensee shall clute technetium 99m pertechnetate from molybdenum 99[

technetium 99m generators and/or prepare radiopharmaceuticals from reagent kits in accordance with:

(A) The manuf acturer's specifications contained in the package insert; and (B) Stacoments, representations, and procedures contained in application received August 26, 1974.

14. Technetium 99m labeled sulfur colloid preparations which appear flocculent or aggregated shall not be used in humans.

15. Except as specifically provided otherwise by this license, the licenses shall possess and use byproduct material described in Items 6, 7, and 8 of this license in accordance with statements, representations, and procedurcs con-.

tained in application received August 26, 1974, and letter received September 12, 1974. signed by Dr. John A. D' Alessandro, j

For the U. S. Atomic Ener Commission SEP I31974 (V

Haterials Branch Date by oirectorate of Lic.nsin 40NTROL NO. 8 0' 7 14

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UNITED STATES NUCLEAR REGULATORY COMMISSION '

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f 799 ROOSEVELT RO A.D GLEN ELLYN, ILUNois 601 H g

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JAN 241986 Trail Clinic, P.C.

ATTN: Larry G. Heggemeyer Director of Special Studies 18254 Livernois Detroit, MI 48221 Gentlemen:

Enclosed is Amendment No. 07 renewing your NRC License No. 21-18991-01 in accordance with your request.

Several new conditions have been incorporated in your license.

In view of this, please review your license carefully to assure that you understand and are in compliance with the terms and conditions contained therein. Please note that we have not authorized ochn A. D' Alessandro, D.0. or Irvin Z. Phillips, D.0. as authorized users on NRC License Number 21-18991-01.

The referenced license you submitted, NRC License Number 21-16254-01,- for their training does not appear in our records. You may resubmit their names with their qualifications and experience, in accordance with Regulatory Guide 10.8, October 1980, at a later date as additional information for our review.

Please review the enclosed document carefully and be sure that you understand all conditions.

You must conduct your program involving radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations.

In particular, note that you must:

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.

2.

Possess radioactive material only in the quantity and form indicated in your license.

3.

Use radioactive material only for the purpose (s) indicated in.your license.

4.

Notify NRC in writing of any change in mailing address.

5.

Request and obtain appropriate amendment if you plan to change ownership of your organization, change locations of radioactive material, or make any other changes in your facility or program which are contrary to your license conditions or representations made in your license application and any supplemental correspondence with NRC. Any amendment request should be accompanied by the appropriate fee specified in 10 CFR Part 170.

/

CONTROL NO. 8 0 714

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EPORT OF YOUR CONTINUING MEDICAL EDUCATION ACTIVITIES HAS BEEN COMPILED FROM DOCUMENTS TED TO AND VERIFIED BY THE ADA OFFICE OF CME AS OF THE DATE INDICATED, ALL ACCEPTABLE CME HOURS EEN RECORDED. EVEN THOUGH THEY MAY EXCEED THE MAXIMUM ALLOWABLE FOR A PARTICULAR CATEGORY.

(OURS APPLICABLE TO YOUR AOA CME REQUIREMENT ARE INDICATED IN THE STATISTICAL

SUMMARY

. COMPLETE ATION CONCERNING THE REQUIREMENTS. GUIDELINES AND PROCEDURES OF THE AOA PROGRAM MAY BE FOUND CME GUIDE. IF YOU FEEL AN ERROR HAS BEEN MADE IN THIS REPORT. PLEASE CONTACT THE CME OFFICE AFD '

APPROPRIATE DOCUMENTATION SO THAT YOUR RECORD MAY BE CORRECTED.

PAGE 1

J3HN A D'ALESSANDRO D.O.

38

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J. L HOURS APPLICABLE TO YOUR AOA CME REQUIREMENT ARE INDICATED IN THE ST ATISTICAL SUt.4 MARY. COM' RMATION CONCERNING THE REQUIREMENTS. GUIDELINES AND PROCEDURES OF THE AOA PROGRAM MAY BE O NE CME GUIDE. IF YOU FEEL AN ERROR HAS BEEN MADE IN THIS REPORT. PLEASE CONTACT THE CME OFFIC(

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PAGE-

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PAGE 1

^ ^ "

04691 04691 JOHN A D'ALESSANDRO D.O.

X AD A Mc MBE R, REQUIRE D 70 TONNANCOUR PL AO A utuBE R. E X E MPT GROSSE PT FARMS MI 48236 NoN utuatR 0.O Cut nouss RtQuiReo FROM 01/01/83 To 12/31/85 DAT A RECORDED AS O, 01/20/8C PROGRAM OATL NJMBiR NAME CATEGORY HOURS 01/19/83 00236 ENZYME INHIBITION /MT'SINAI CHCL 2D 3.0 01/22/83 00381 SUPERBOWL OSTE MED SEM/MI OSTE M 1A 7.0 02/26/83 02748 ULTASND BASC SCI / HENRY FORD HOSP 2D 12.0 03/12/83 05906 DIAGNOSTIL ULTRASND/MI SON 0 GRAPH 20 10.0 03/19/83 01634 WEEKEND OV PSYCHIATRY /MI OSTE ME 1A 4.0 03/2*/83 02751 REGNL GRP MTG/ DETROIT REG ULTSND 20 2.0 05/11/83 01661 ARTHRITIS UPDT 1983/UAYNE ST UNI 2D 4.0 05/19/83 02246 84TH ANN PG CONF /MAOP&S 1A 23.0 05/19/S3 02751 REGNL GRP MTG/ DETROIT REG UL TSND 2D P.0 06/22/83 02751 REGNL GRP MTG/ DETROIT REG ULTSND 20 2.0 09/24/83 03411 ENDOCRNOPATHIES/MI OSTE MED CTR 1A 6.0 10/23/83 02751 REGNL GRP MTG/ DETROIT REG ULTSND 2D 2.0 11/07/83 01423 CME / HENRY FORD HOSP 2D 1.0 12/03/83 04785 ADVS IN CARDIOLOGY /MI OSTO MED C 1A 8.0 12/07/83 02751 REGNL GRP MTG/ DETROIT REG ULTSND 2D 2.0 12/14/83 04822 INFECT DX UPDATE 1983/UAYNE ST U 20 5.0 01/21/84 05574 SUPERBOWL OSTE 0 MED SEM/MI OSTE 1A 6.0 03/17/84 06346 NEW PRESPECT LIFE CYCLE /MI OSTE 1A 6.0 05/03/84 07251 PEDIATRIC RADIO /AM OSTE CLC RADI 1A 20.0 09/22/84 08852 OPHTHALMOLOGY FAML PRACT/MI OsrE 1A 6.0 10/23/84 09631 INFECT DX UPDATE /U-MI 2D 6.0 12/05/84 10766 LECTURES /UILLIAM BEAUMONT HOSP 20 4.5 04/17/85 10362 CAPHALOSPORIN THERAPY / GLAXO INC.

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SUMMARY

. COMP H.*ATION CONCERNING THE REQUIREMENTS. GUIDELINES AND PROCEDURES OF THE AOA PROGRAM MAY BE F l

%E CME GUIDE. IF YOU FEEL AN ERROR HAS BEEN MADE IN THIS REPORT, PLEASE CONTACT THE CME OFFICE AND

Y APPROPRIATE DOCUMENTATION SO THAT YOUR RECORD MAY BE CORRECTED.

PAGE 1

I M. I N Z PHILL;P3 3. _'.

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1 3., Cut HOURS REOUiREo r ROu ggf33jgq 70 13/31/62 DATA RE CORDED AS OF 12/31/32 i

PROGRAM 1

DATE NUMBER NAME

. CATEGORY HOURS

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2/10/ 30 00457 oc t au u:/00 U ELu "E) COLL 2-D 22.50 35/15/30 321 0 alsi A r let oc:T3P:cerTF c xF/MAOPS 1-A 27.00 11/07/3C 33 94:' 25T-A N r J;.L cc WENT:M./LSS V! GAS /AGA 1-A 22.00

)& J1/16/31 34 741 aTi UQUAL CTF4ESHER C 3t t s E / a c 0 Fs 1-A 21.50 5 J2/05/ 31 05 ?!o :A0: 3L3cy/rpeu-A/c;r* JELL UNIVE4SITY 2-D 24.53 t

05/07/ 31 3,d91 : ::,0 A n uAL cCNFiara tr/~toods 1-A 27.03 3 10/1 d/ 31 055C 54TH A W CL t tSS?F/A:/JS 1-A 22.00 j t s 2/ 21/ 3 2 11 9,

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TOT A L ACCE PT ABLE HOURS APPLICABLE AOA 1B 1C 10 1-E 1F a

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u REPORT OF YOUR CONTINUING MEDICAL EDUC ATION ACTIVIT6ES HAS BEEN COYPILED FPOV DOC U Y E NT

-TTED TO AND VERIFIED BY THE AOA OFFICE OF CME AS OF THE DATE IND:CATED ALL ACCEPTABLE CME ~OUR SEEN RECORDED. EVEN THOUGH THEY MAY EXCEED THE MAXIMUY ALLOWABLE FCR A PART!CULAR CATEGOPN HOURS APPLICABL E TO YOUR ADA CVE RECUlREMENT ARE INDICATED IN THE STATISTIC AL SUYY ARY COYFLET Y ATION CONCF.hN NG THE REQUIPEMENTS. GUIDELINES AND PROCEDURES OF THE ACA PROGRAD M AY BE FOUNI E CME GUIDE. IF YOU FEEL AN ERROR HAS BEEN MADE IN THIS REPORT, PLEASE CONTACT THE CME OFFICE AN!

Y APPROPRIATE DOCUMENTATION SO THAT YOUR RECORD MAY BE COA RECTED.

PAGE 1

IRWIN Z PHILLIPS D.O.

16268 18410 W MC NICHOLS RD X Ao A vt uet a ar ou;Rm DETROIT MI 48219 Ao A ve vee a. n E var NoN vEvetR 5 0. 0 CME HOURS AEQUIRED r pou 01/01/83 To 12/31/85 CATA RECOHOF D AS cr 12/04/85 PROGRAV OATE NJvsE P NAME CATEGORY HOURS 4

01/10/83 00176 IMAGING SYMPOSIUM /U-CA 2D 27.0 4 02/13/83 00556 RECENT ADV RADIOLOGY /NY H-CORNEL 20 32.5

+ 11/07/83 04314 43RD ANN CONV SCI SESSIONS /ACOI 1A 26.5 4 01/19/84 05524 11TH ANN DIAG RADIOLOGY REFRESH /

1A 20.0 S 04/09/84 06799 84TH ANNU MTG/AM CLG RADIOLOGY 2D 21.0 11/04/84 09506 89TH ANNUAL CONVENTION /A0A 1A 21.0 04/23/85 12218 AZ-NV-UT OSTE CONV/AZ OSTE 0 MED 1A 36.0 7

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