mercy jeannette hospital, additional information … that he/shc actually spait in the activity....

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To:215 337 5269 P. 2'3 MQR-13-2006 11:08 From:MRCY JNNTTE ELECTRO Mercy JeanneHs Hospital I , 600 Jcffcrson Avcnuc 724 527 355 1 telephone I I .l+!;~~t~Wll+, PA 1 SS4A 1 Attenti0n;Christopher Hott Mall Control Number: 138191 U S.N.R.C. Region 1 Division of Nuclear Materials Safety 475 Allendale Road King of Prirssia, PA 19406-1415 March 13,2006 RE. License # 37-15471-01 9 Mercy To Whom It May Concern. Please amend tne above referenced license for our facility to reflect the following changes' Add the following physician as an authorized user for oral administration of 1-131 for Hyperthyroid and Thyroid Cancer treatment under Part 35.300: Man1 Bashyam, MD For training and experience please refer to the enclosed document of training from the American Association of Clinical Endocrinologists, Dreceptor form 31 3A, and supporting documentation. Also, please Update information for authorized user Stephen Kowalyk, MD to use of oral administration of 1-131 for Hyperthyroid and Thyroid Cancer treatment. Please reference Westmoreland Regional Hospital NRC materlal license 030- 09731 which lists him as a user for Hyperthyrold and cancer treatment. Also. please add 35.500 to our material license for maximum amount of 500 mCi's. Please update authorized user Shyam Vijay Gohel, MD to include Use of sealod source for medical diagnosis Part 35,500. This usage would be for 2 Gd-I53 Profile attenuation correction sources installed in a Siemens E-cam system, Manufacturer: Isotope Products Laboratories Model No: NES-8726 Activity: 100-1 25 mClleach (Total max:250 mCi) After installation, training will be given by application specialist to all users In the correct handling and usage of sources Please refer to the enclosed document entitled Siemens NM Cllnlcal Applications Training Checklist, which details training that will take place. w morcyllnk oru Pwl ot lhe Plltsburgh Morcy I lealih Syslsm and Caihnlic Hnnlrh Easi. spoiiworcd try llio Sislcrs 01 Mercv Moa

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To:215 337 5269 P. 2'3 MQR-13-2006 11:08 From:MRCY JNNTTE ELECTRO

Mercy JeanneHs Hospital I , 600 Jcffcrson Avcnuc 724 527 355 1 telephone I

I . l+ ! ;~~t~Wl l+ , P A 1 SS4A 1

Attenti0n;Christopher Hott Mall Control Number: 138191 U S.N.R.C. Region 1 Division of Nuclear Materials Safety 475 Allendale Road King of Prirssia, PA 19406-1415

March 13,2006

RE. License # 37-15471-01

9 Mercy To Whom It May Concern.

Please amend tne above referenced license for our facility to reflect the following changes'

Add the following physician as an authorized user for oral administration of 1-131 for Hyperthyroid and Thyroid Cancer treatment under Part 35.300:

Man1 Bashyam, MD

For training and experience please refer to the enclosed document of training from the American Association of Clinical Endocrinologists, Dreceptor form 31 3A, and supporting documentation.

Also, please Update information for authorized user Stephen Kowalyk, MD to use of oral administration of 1-131 for Hyperthyroid and Thyroid Cancer treatment.

Please reference Westmoreland Regional Hospital NRC materlal license 030- 09731 which lists him as a user for Hyperthyrold and cancer treatment.

Also. please add 35.500 to our material license for maximum amount of 500 mCi's. Please update authorized user Shyam Vijay Gohel, MD to include Use of sealod source for medical diagnosis Part 35,500. This usage would be for 2 Gd-I53 Profile attenuation correction sources installed in a Siemens E-cam system,

Manufacturer: Isotope Products Laboratories Model No: NES-8726 Activity: 100-1 25 mClleach (Total max:250 mCi)

After installation, training will be given by application specialist to all users In the correct handling and usage of sources Please refer to the enclosed document entitled Siemens NM Cllnlcal Applications Training Checklist, which details training that will take place.

w morcyllnk oru Pwl ot lhe Plltsburgh Morcy I lealih Syslsm and Caihnlic Hnnlrh Easi. spoiiworcd try llio Sislcrs 01 Mercv M o a

e Mercy

I Mercy Jeanncttc Hospital BUU Jefferson AVWIJA Jeannette. PA 15Gd4 ’ 724 527.355 T I H I H ~ I O I I H

Enclosures

Delete the following authorized users:

Usha PI. Kanakarnedala Lawrence A Denino Daniel M O’bioark

Please feel free to contact the facilities RSO at (724)527-9252 with any questions.

Sincerely,

Edwin Miller, RSO RSO, Mercy Jeannette Hospital

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MRR-13-2006 08:58 From:MRCY JNNTTE ELECTRO T o : 2 1 5 337 5269 P. 7/17

Siemens NM Clinical Applications Training Checklist - 2 - General Guidelines for Applications Training (Also see Pre-Application Checklist)

During the turnover, a maximum of 2 technologists should be dedicated for the training period.

Q Training for profile is 12 hours.

Applications training should commence during normal business hours. Personnel from the 2nd or 3'd shift that are to be trained should be brought in at this time.

Technologists scheduled for training must be removed from all responsibilities such as phone calls, scheduling of patients, coverage for other areas of department

NRC and State inspections are to be completed no later than the week prior to the arrival of the applications specialist.

Applications on OEM equipment (Le,: laser imager) should be done prior to the arrival of the Siemens applications specialist.

NM Clinical 'l'urnover Checklist 3-2004

MfX-13-20El6 08:58 From:MRCY JNNTTE ELECTRO To : 215 337 5269 P. 8/17

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Siemens NM Clinical Applications Training Checklist - 3 -

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- *

. . . . -

. . . .

. -

-.

-. . . . . .. -

Site Readiness Checklist

[terns to Check-off 1-

Profile Sources loaded and operational 1 OmCi of Tc99m for QC testing

Date I O rn p'e ed i

Co57 sheet source to cover entire detector FOV (1 0 mCi less than 18 months old) Bar Phantom (if applicable)

Departmental Procedure Manual readily available or c.urrent Acquisition Protocols Room Clean and stocked and " - "patient ready"

I I t-- +

NM Clinical Turnover Checklist 3-2004

To:215 337 5269 P. 9/17 MQR-13-2006 08:59 F r o m : M R C Y JNNTTE ELECTRO

Siemens NM Clinical Applications Training Checklist - 4 - Overview of NM Applications Training Schedule

Day 1: Please s-chedule two Patients for the afternoon

Arrival of application specialist Safety Issues System Quality Control Procedures Camera and Gantry Explanation Acquisition Protocols Review of Recommended scanning Protocols

Last Day: Schedule a routine patient schedule Review checklist with customer Scanning Procedures, Processing and Options Image Evaluation and Film Technique Post Installation Meeting

Address application issues from post installation meeting

NM Clinical Turnover Chccklist 3-2004

To:215 337 5269 P. 10'17 MRR-13-2006 08:59 From:MRCY JNNTTE ELECTRO

..I - . -.

Pacilityl Site nnmc:

Dept.:

Address: D Home W Work

City, Stnte Z5t code:

Tech. phone: U Home

Tech. C I ~ ~ I :

- .. -

0 WCrk

, L A S t four of SOC. Sec. #: J

Siemens NM Clinical Applications Training Checklist - 5 - Siemens Application Training Checklist

Course title: e.cam profile 4.0 turnover

ASRT RcC. ff NCZO19SC)I 6 Pussible credits: 11.5 Crediu awarded:

- .."..- Date:

Apps Spec. Signature: Datc:

hatructions: Upon completion of training, fonvard this shcct unfy LO MJC in onc of thc l'ollowing ways. Pleasc call 866-535-4528 with m y qucslions.

Mail Fax MIC 973-574-800 1 CE Scrvices - Siemens 1037 Koutc 46 Easi Clilion. N.T 0701 3

NM Clinical Turnover Chccklist 3-2004

To:215 337 5269 P. 11/17 MQR-13-2@@6 @8:59 Frorn:MRCY JNNTTE ELECTRO

Siemens NM Clinical Applications Training Checklist - 6 -

To be initialed by both technologist and applications specialist:

Topic I ni tia Is

Profile Theory Review Profile Lectwc

Gantry llardware Orientation Support -m.L/Profile Wings End Plate Removal Loading Profile Sourccs

30 min

Display Panel I Yersistcnco Scape

tiantry Display Detector Movement / Configuration

PPM Display during Acquisilion

(PPM)

Patient Positioning Monitor (1'PM) Display -. .

c.cam Cali brations Preparing Point Sourccs Camera Preparation Peaking & Tuning nlank Scans Daily QC / hi t id QC Monthly QC Profilc Sourcr: Replenishment Ordering Profile Sources 'l'roublmhootinp Tecluitqucs

e-soft

Time

120 min

Ac (1 11 is i ti o n W o rkfl o ws Rcvicw & Modify Acquisirion W O X ~ ~ ~ O W S Toino C(c. hled-Tomo Acq. - - Profile Acq. Workflows

Patient Sctup dk Positioning Cardiac Torno lmaging

45 niin

90 min

90 inin

30 inin

NM Clinical Turnover Checklist 3-2004

MQR-13-2006 88:59 From:MRCY JNNTTE ELECTRO T o : 2 1 5 337 5269 P. 12/17

Siemens NM Clinical Applications Training Checklist - 7 - Proccssing Workflowa Quality Control (Motion Correction) Auto Car& ac 3D Orientation

Flexible Display Profile Revicw Linking to additional programs Dual Monitors Saving Jl'EG. BMP, EMF & AVT

Third Party Packages 4D-MSPEC"I'

Mannuids Keviewcd

Cleaning off System

Review with Physician

Wand Out Survey

60 min -. -

30 min

-.. . .-

1 5 inin

10 min

60 mill

1 mi i i

Introductory call to UPTIME Service Center Applications Hotline Yes lNo

Contact Phone

E-mail Address

Functional Location Number

System Model No. and Serial No.

Applications Specialist Name Date

Trainee Signature Date

NM Clinical Turnover Checklist 3-2004

To:215 337 5269 P. 13/17 flQR-13-2006 08:59 F r o m : M R C Y JNNTTE ELECTRO

--- M@mh and Year

-WOW Curtifid Specialty Board

I I

tadhtlon Phydcs and InsburnenCdon

!

s)

btxipt ion of Experience

To :215 337 5269 P. 15/17 MgR-13-2006 08:59 From:MRCY JNNTTE ELECTRO

Rc FORM 3 l m F-- =m W N N O AND KXPEWENCE AND PRECEPTOR BTATERWT (continuad)

Name of Progmm and Larcrtlon with

CwnaspondFng

License Number

2 YES -J N/A of the RBO for Lloense Na

CamploW i-year of fulktme radlethn safety eqmrisnce Qn areas t8ertUM In item Sa) under a u p e m n

0. Address ,

~~~ To:215 337 5269 P. 16/17 MQR-13-2006 Q9:08 From:MRCY JNNTTE ELECTRO

. YES a NIA

IO. me i n m u a l namcrd In item ifias SJtirfSctoriaIly wmp~trted udning rsqutnments in 10 CFR 35980 and is competent to lndapenderrlly apamte h nudaar pharmacy.

~ __ 12. PRECBPIOR 4PPROVKNO CErCrtRCAllON

I cerUfythe appmMll of Barn 10 and oem I am an hthorhpd Nudeer P h a m &

or 0 I tertifit the approvd) of bms 113 end I lb . ~ n d cerfg I 0m an Aubwttcsd Nudbsr,Phermac(m,

or a 1 cam the approval of bme I I a and 11 b, end 1 0erCrr)l that I meet the regukernehtrr of .. 190 ,792 394.

. .

TOTQL P.04

October 5.2005

Ucar Dr. Bashym:

'The iliniericm Association of Clinical Endominologists (ARCE) cMtifics that you suc~essfully completed the folJowing educational activity:

Progarn Title: AACE Nuclear Medi&c Course Date: September 24-October 1,2005 Location: Kansas City, MO Awarded: 80.25 category 1 credit(s) toward the A M A Physician's Rccofinition Award

' h e Amencan Association of Clinical Endocrinologists (AACE) is acmehted by the Accreditation C o u n d for Continuing Medical Education (ACCME) to provide coutinuing medical cducntion for physicims.

The Amxican Association o f C h k d Endoc~i~~ologist~ designates h s educational ac?ivity for a maximum ufR0.25 category 1 crcdits toward the AMA Physiciiau's Recognition Award. Each physician should claim only thosc credits that he/shc actually spait in the activity.

Plcaw feel fiec to contact thc AACE 06cx if you have any questions,

Sincexely,

AACE CME Department

PERSONAL IMFQWUATIOM WAS REMOVED BY NRC. NO CQPY OF THIS INFORMATION

WAS RETAINED BY THE NRC.