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NM' VN,RC,, FORM 374 U.S. NUC'LE AR RE'GULAToRY COMMISSION PAGE OF _.- PAGES

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NI ATERI AI.S 1.lCENSE Amendment No. 24 [@y' Pmsuant to the Aionne Energy Ad of 1954, as , unended. the Energy Reorganvation Act of 1974 (Pubhc Law 91-438), and Title 10. Code of;

i|fl l'edcral Regulations. Chapter 1. Paris 30. 31. 32,33,14. 35,36,39. 41), and 70. and m rehance on staternents and representations heretof ore ma le ?Q by the bcensee, a heense is hereby swued authon/ing the beensee to receise, acquire, powcw, and transfer by produet, source, and special nuclear Eh material designated below; to use such material for the purposeN and at the placeN desi nated below; to deliser or transfer such material to 8F

d persons authorized to receise it in accordance with the regulations of the applicable PartN. This license shall be deemed to contain the conditions h% 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 j@E$g Nuclear Regulatory Comminion now or hereaf ter in effect and to any conditions specifiel below.

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if UN. hE0020 CG,TY |A |

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b{hLicensee In accordance with the application dated

i September 24, 1996,L Cardiology Associates of Fairfield .L l.ieense Number 06-07795-01 is amended in >@|; County, P.C. its entirety to read as follows:

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|| 2. 111 East Avenue,@ |'lj Norwalk, Connecticut 06851 A thpiration Date November 30, 20053 |

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5. Docket or030-01271 El| Reference No.

ih 6. By product. Source. and/org

7. Chemical and/or Ph>sical 8. Maximum Amount that Licensee 9-

O||Q1Special Nuclear Material Form May Possess at Any One Time G.

3 Under This License t |

|9g A. Any byproduct material A. Any radiopharmaceutical A. As needed l"i 1identified in 10 CFR identified in 10 CFR 4,|d 35.100 35.100 4 |ffB.Anybyproductmaterial B. Any radiopharmaceutical B. As needed i

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| identified in 10 CFR identified in 10 CFR|q %'s35.200 35.200 except generatorsj and gas (i

l 'e9. Authorized use

'h A. Any uptake, dilution and excretion procedure approved in 10 CFR 35.100.Qb B. Any imaging and localization procedure approved in 10 CFR 35.200.Q

h'g 'sCONDITIONS C

9 p6a 10. Licensed material may be used only at the licensee's facilities located in Norwalk, Lj Connecticut, at 111 East Avenue, and at 40 Cross Street.Is

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j 11. The Radiation Safety Officer for this license is Mark Heiman, M.D. 5Jg

If12. Licensed material listed in Item 6 above is only authorized for use by, or under the !g supervision of the following individuals for the materials and uses indicated:

|| hthorized Users Material and Use "}Murray A. Rosenberg, M.D. 35.100; 35.200

,{,5 Mark Heiman, M.D. 35.200 for cardiovascular clinical procedures

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(gIn addition to the possession limits in Item 8, the licensee shall further restrict

!g| the possession of licensed material to quantities below the minimum limit specifiedin 10 CFR 30.35(d), 40.36(b), and 70.25(d) for establishing financial assurance for gdecommissioning. '

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NRC FORM 374 A, L , CLEAR REGULATORY COMMISSION*

PAGE 2 or 2 exceswI.-

g! lxense Numberg 06-07795-01IN MATERI ALS LICENSE IMet or Referena Numberg| SUPPLEMENTARY SHEET 030-01271n!

a y Amendment No. 24 ,

14. The licensee is authorized to transport licensed material in accordance with the $g provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."

15. Except as specifically provided otherwise in this license, the licensee shall conduct, its program in accordance with the statements, representations, and proceduresI contained in the documents, including any enclosures, listed be?ow, except for minorN changes in the medical use radiation safety procedures as provided in 10 CFR 35.31. '

N The U.S. Nuclear Regulatory Commission's regul.ations shall govern unless thestatements, representations, and procedures in the licensee's application and '

correspondence are more restrictive than the regulations. '

N- A. Application dated February 15, 1995 iN B. Letter dated September 6, 1995 'W C. Letter dated October 2, 1995B D. Letter dated September 24, 1996 *W E. Letter dated October 31, 1996 'N

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For the U.S. Nuclear Regulatory Commission I

| NOV l 51996 Original Signed By: |W Date By John D. Kinneman iN

NNuclear Materials Safety Branch I

NRegion I E

RKing of Prussia, Pennsylvania 19406 E.

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NOV i 51996

Mark Heiman, M.D..

Radiation Safety OfficerCardiology Associates of

.Fairfield County, P.C.

' 111 East AvenueNorwalk, CT 06851

11

Dear Dr. Heiman:

This refers to your license amendment request. Enclosed with this letter is theamended license. Please note that as part of this amendment, in accordance with10 CFR 30.36, effective February 15,1996, the expiration date of your license has

: been extended by a period of five years. The new expiration date is stated in item 4| of the license.<

j The new location of use is added to your license. Please be advised that your currentlocation of use of licensed material can not be deleted from your NRC license until youd

have removed alllicensed materials, including the radioactive waste, and the facilityhas been decontaminated to meet the criteria for release for unrestricted use(Enclosure 2). At that time you may submit a request for an amendment to your

j license to remove this facility from your license.|

.

Please review the enclosed document carefully and be sure that you understand and |fully implement all the conditions incorporated into the amended license, if there are '

any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region1 Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provideappropriate corrections and answers.

Thank you for your cooperation.

Sincerely,

Original Signed By:John D. Kinneman

John D. Kinneman, ChiefNuclear Materials Safety Branch 2Division of Nuclear Materials Safety

License No. 06-07795-01Docket No. 030-01271Control No. 123744

OFFICIAL RECORD COPY

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M. Heiman, M.D. -2-,

Cardiology Assoc. of ); Fairfield County|4

Enclosures:1. Amendment No. 242. Guidelines for Decontamination of Facilities and

Equipment Prior to Release for Unrestricted jUse or Termination of Licenses for Byproduct, Source, )or Special Nuclear Material

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DOCUMENT NAME: R:\WPS\MLTR\LO607795.01To r.c.iv. . copy oe tw. soco ne. indic.i. in th. t$ P 'C' = Copy w/o attaph/enct *E" Copy w. *tsch/.nct *N" - No copy

OFFICE DNMS/RI ,, |N Dl IMS/_RI |pNAME SLodhi QV JK $4 manDATE 11/08/96 Ill 4/96 11/ /96 11/ /96

OFFICIAL RECORD COPY

A) Martin J. Krauthom?"'Q. FACC Jesus F. Wp. Jr. MD FACC, , .*

| 1 Robert S. Moskowit j FACC Abrohom B. Bornstein. MD FACC..

b Stephen R Michoelh.rMD. FACC Edword H. Schuster. MD. FACC* Ralph J. Kirmser. MD. FACC Samuel J. Brodsky. MD. FACC.

George R. Nelson. MD kori E. Alcon, MD, FACCCharles B. Augenbroun. MD. FACC Mark D. Heimon. MD FACC

ms-16 |

Cardiology Associates of Fairfield County, P.C. Mli iii East Avenue, Norwolk CT 00851. .. . (203) 854 9212

|..... .

| 40 Cross Street, Norwolk. CT 06851 . (203) 845-2160.

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October 31, 1996

REFERRENCING LICENSE #06-07795-01DOCKET #030-01271CONTROL #123744

Mr. John D. KinnemanChief Nuclear Material Safety Branch 2Division of Nuclear Material SafetyUnited State Nuclear Regulatory CommissionRegion 1475 Allendale RoadKing of Prussia, Pennsylvania 19406-145

| Dear Mr. Kinneman:

I am writing this letter in response to your letter dated October 24, 1996

| concerning our request for a change in location on our License #06-07795-01dated September 24, 1996.

First, I wish to reiterate the statement in our most recent application for our;

i renewal of license which is dated 2/15/95 and which states in Attachment Athat this license will not obtain a 99m Tc/99 Mo generator. There is nointent to purchase any materials in " bulk" form, and all radiopharmaceuticals

| will be obtained in unidose form from a licensed Radiopharmacy.

Some radioactive waste from the Radiopharmacy (i.e., unused unidoses orsyringes containing radioactivity) will be returned to the radiopharmacy for

,

| disposal. Records of this transfer will be maintained by the Applicant. Other| wastes, such as used syringes, tubing, sponges, wipes or other contaminated I

materials, will be held by the Applicant in storage for decay in storage.

| These materials may have an associated biohazard which makes them non-returnable; to the radiopharmacy. The facility design will meet 10 CFR 20.1101 and 10 CFR

I' 20.1301 requirements, or a more restrictive state regularatory limit, for exposure

| limits for the radiation worker and the general public.

I

| Please note that shielding will consist of (as indicated in the accompanyingdiagram): 1. A type L lead shield.'

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|.

OFFICIAL RECORD COPY ML 10 W.5EIG'

17 Old Kings Highway So. 38 Grove Street 1275 Summer Street 225 Morn StreetDorien. CT 06820 Ridge 6 eld. CT 06877 Stamford, CT 06905 Westport Cf 06880

| [203) 655-1416 (203) 438 0779 (203) 353-1133 (203) 226-7461

|

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(2) Mr. John Kinneman10/31/96.

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2. A lead waste storage container one-half inch thick. As well as; sharp shield lead lined container ( Biodex Medical Systems| Model #039-350., specifications attached).!

Lead syringe shields.

Lead carrying case.

Standard lead bricks as indicated in the diagram.

Please note that the area across the walls from use and storage locations are indicatedin the diagram sent along without our letter dated September 24, 1996. As indicated,these areas are within our office location and therfore remain restricted to thegeneral public. Specifically, the area across the walls from our use and storagelocations include the exercine treadmill room. The licensee shall conduct operationsso that the total effective dose equivalent to members of the public does notexceed 0.1 REM per year. Furthermore, a dose in any unrestricted area will notexceed .002 REM in any hour. i

||

Please also note the following regarding |

A. The storage of radiopharmaceuticals: There will be no refrigerated |radiopharmaceuticals stored. A minimal amount of radiopharmaceuticalswill be on hand at any time. A licensed radiopharmacy shall deliverradiopharmaceuticals in a lead lined storage case, with the radio-pharmaceuticals conained inside lead syringe holders. These willbe kept in the indicated hot lab area.

B. Radioactive waste will be stored in the previously described leadlined containers for decay in storage as previously described inour application. Once again, these containers will be kept in theindicated hot lab area on the ground level below the counter.

|C. Preparation and dispensing of radiopharmaceuticals: Unit doses willbe removed from the lead lined container and the leaded syringeholders and used at counter top level in the area surrounded by theL shield and lead brick shielding as indicated in the accompanyingdiagram.

The diagram also indicates areas across the walls from the use and storagelocation indicating that access to the general public is resticted.

The measures outlined above and in accordance with our license applicationattachment Q, Q2 and Q3 will insure that radiation levels in unrestricted areaswill not result in doses to indivii 21 members of the public in excess of those

specified in 10 CFR 20.1301.

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(3) Mr. John Kinneman10/31/96

Thank you very much for your prompt attention to this response. As indicated,our relocation will be effective December 1, 1996. Therefore, our hope is thatthis matter can be resolved prior to that date.

Sincerely,

t .W

Mark D. Heiman, M. D. RSO

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OCT 2 4 l996

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License No. 06-07795-01Docket No. 030-01271Control No. 123744

Mark D. Heiman, M.D.Radiation Safety OfficerCardiology Associates of

Fairfield County, P.C.111 East AvenueNorwalk, CT 06851

Dear Dr. Heiman:

This is in reference to your request dated September 24, 1996, to amend yourNuclear Regulatory Commission (NRC) License. Please note that the diagrams ofyour facility do not provide the necessary details, and it appears that thenew facility is not complete. Please submit a detailed diagram of yourcompleted facility, and indicate the position of each of the areas described

,

below (a-c) and describe the type, dimensions, and thickness of shielding that |

you will use. Exhibit 6 of the enclosed regulatory guide may be helpful inpreparing your response and provides an example of a facility diagram that isacceptable to the NRC.

a. Storage of radiopharmaceuticals (refrigerated and nonrefrigerated). |

b. Storage of radioactive waste, including decay-in-storage prior to i

disposal as nonradioactive waste. If this area is not located !within your main department, describe how you will secure the |

material. 1

c. Preparation and dispensing of radiopharmaceuticals (e.g., lead glassL-block,etc.).

1

In addition, identify adjacent areas across the walls from use and |storage locations and show that adequate steps have been taken to assurethat radiation levels in unrestricted areas will not result in doses toindividual members of the public in excess of those specified in10 CFR 20.1301 (enclosed). 1

We will continue our review upon receipt of this information. Please reply induplicate to my attention at the Region I Office and refer to Mail Control No.123744. If you have any technical questions regarding this deficiency letter,please call Dr. Sattar Lodhi at (610) 337-5364.

j|If we do not receive a reply from you withia 30 calendar days from the date ofthis letter, we shall assume that you do not wish to pursue your application.

0FFICIAL RECORD COPY

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M. Heiman, M.D. -2-Cardiology Associates ..

Your cooperation with us is appreciated.

Sincerely,

Original Signed By:Pamela J. Henderson

John D. Kinneman, Chief. / Nuclear Materials Safety Branch 2

Division of Nuclear Materials Safety

License No. 06-07795-01Docket No. 030-01271Control No. 123744

Enclosures:1. 10 CFR Part 202. Regulatory Guide 10.8

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DOCUMENT NAME: R:\WPS\DLTR\LO607795.01To resolve a copy of this document. indleate in the boa: 'C' = Copy w/o attach /enct *E" = Copy w/ attach /enci *N' = No copy

0FFICE DNMS/RI A y N DNMS/RIN#)/t[L/ ,

NAME Stodhi W hnJKinneman' I

DATE 10/11/96 " // 10/Jt//96 10/ /96 10/ /96 -

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0FFICIAL RECORD COPY

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MNSB TELEPHONE CONVERSATION RECORD

Person Called: M&rk Heiman, M.D., RS0 Phone No.: (203) 854 9212

Person Calling: Sattar Lodhi Date: 10/1/96

Facility Name: Cardiology Associates Time: 10:15 a.m.of Fairfield County

License No. 06-07795-01 Docket No. 030-01271

Subject: Additional Information for amendment|

Summary: I called Dr. Heiman to request:

(I request detailed and clear diagram of nuclear medicine use area,including the hot lab set up, location of dose calibrator, dosepreparation and storage areas;

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(2) Any addition or deletion of authorized users to the license; G,y

I also explained to him that their request to move to a new loce. tion is goingto be processed in two parts; first the new location will be added to theirexisting license, and then once they have removed all materials and the

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facility is decommissioned for release, they will need to request an other jamendment to delete the old facility, and change the mailing address; 1

Action Required /Taken: Document / wait for response j

,

Signature: Mail Control No. 123744

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/ Robert S. Moskow( ). FACC Abraham B, Bornstein. MD, FACC.

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St phen R Michaela.'MD, FACC Edward H. Schuster. MD. FACCi

Rolph J, Kirmser, MD. FACC Samuel J. Brodsky, MD, FACC.

George R. Nelson MD Karl E. Alcon, MD, FACC'

Charles B. Augenbraun, MD, FACC Mark D. Heimon. MD. FACC

D Cardiology Associates of Fairfield County, P.C.

iii East Avenue, Norwolk, CT 06851. .X. . . . (203) 854-9212b. ...

40 Cross Street, Norwolk, CT 06851 (203) 845-2160.

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September 24, 1996

!

United States Nuclear Regulatory CommissionMedical Licensing Section475 Allendale RoadKing of Prussia, PA 19406

Dear NRC Official:

Cardiology Associates of Fairfield County, P.C. hold USNRC Byproduct MaterialsLicense 06-07795-01. We wish to amend our license to allow us to move into anew facility located at 40 Cross Street, Norwalk, Ct. 06851, and vacate ourcurrent facility. We anticipate a need for operation at our new facility12/1/96. We have attached annotated drawings showing the location of ourproposed areas of use of byproduct materials, including the hot lab andscanning room. As indicated, we will purchase Pb bricks with 2 inch thicknessto provide additional shielding in the hot lab as needed to conform to thepublic dose limits of 10 CFR 20.

We confirm that we will continue to perform required area surveys each day ofuse, and wipe surveys each week of use, when we move to the new location.We will continue to abide by all the requirements, regulations and conditionsset forth in our license #06-07795-01 in accordance with federal registersection 10 CFR. We confirm also that upon completion of the final decontamina-tion survey and wipe test at our current location we will send you the results,at which time we would appreciate receiving confirmation that we will be ableto release the areas for unrestricted use. As part of this same amendmentrequest, we will also be changing our corporate address to that of the newlocation at the time we move (the new address will become our address at thetime we send you the results of the decontamination survery for our currentlocation).

Please contact us if you require additional information. The current licenseamendment fee of $440.00 is enclosed.

Very tr your , s g 4%/

Mark D. Heiman, M. D. R.S.0 W $@) 30 19%*

'0FHClifRECORD COPY UMDH:co

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40 Cross Street 111 East AvenueNorwalks CT 06851 Norwalk, CT 06851

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