P. Bass, MD. FACC N. Bathina, FACC Chrisroplier S. FACC ...

[Pages:32]1' I ldaho Cardiology Associates Re: NRC License #11-27312-01 Amendment Request

Sainual P. Bass, MD. FACC

Munli N. Bathina, MD, FACC

Chrisroplier S. Cadinan, MD, FACC

Andrew U. Chai, MD. FACC

Frderirk M. Costello. MD

Robelt L. h e n ; MD, FACC

Charles E. Eiriksson, MD, FACC

James C. Field, MD, FACC

;.. n. r . .

Jltldlll~

Fry, ME, FACC

David A. Winchinan, MD, FACC

Brian P Nolan, DO

Melinda L. Marks, MD, FACC

Marshall F. Priest, MD, FACC

Karl P. Undesser, MD, PhD, FACC

A m McCreath, NP

Dana Peachey, NP

Shannon Vaughn, NP

Dear Roberto Torres, I am writing to request an expedition on the amendment request previously submitted earlier this

month. I would like to resubmit NRC form 3 13 and the attached documents along with this expedited request based on the following reasons:

Dr Nolan started with our clinic on August 26th,2010 and has been seeing patients in clinic since September 8'h. He has since completed his orientation with our physicians in interpretationof nuclear cardiac studies and is competent in this area.

Since he is also now in the regular rotation for hospital coverage?he would normally be the scheduled physician to interpret all nuclear cardiac studies. Without having him on the NRC license, we have been forced to schedule two physicians on days that he is working just to be able to interpret nuclear studies. Spreading our physicians more thinly this time of year is very difficult because of increased volumes in the clinics and in the hospitals.

Dr Nolan has also completed his CBNC certification exam and is simply waiting to take his cardiology boards in just a few weeks from now. He will then be promoted to 'diplomat' status with the CBNC.

Bringing Dr Nolan to our team of physicians has been a much needed and welcomed addition. Both he and our established physicians are eager for him to have full cardiology privileges with our hospitals and clinics.

Thank you for your understanding and considering this resubmission for expediting the amendment process. I look forward to hearing from you in the near future.

Sincerely,

pd7pp

Rachel Pugmire, RT (R), C N k T , NCT Supervisor, Nuclear Medicine 208-685-21 86 rachelp@,

PO Box I10 Boise. ID 83701 (208) 322-1650 - FAX(208) 322-1695 300 E. Jefferson, Suite 101 - Boise. ID 83712 (208) 336-4141 FAX (208) 336-4035

520 S. Eagle Road. Suite 3103- Meridian, ID 83642 - (208) 987-9828 FAX (208) 884-3096 315 E. Elm Street, Suite 350- Caldwell, ID 83605 - (208) 454-6363 - FAX (208) 454-3512

From:

Sent: To: cc:

Subject: Attachments:

Rachel Pugmire [rachelp@] Monday, September 27,2010 1:26 PM Torres, RobertoJ fairbanj@ NRC license amendment request # I 1-27312-01 NRC BPN letter 9.27.10.doc; BPN NRC license app 9.7.10.PDF

Roberto, Please see the attached letter, NRC form 313 and attached documents. I would like t o resubmit my original request t o you as an expedited request. A full explanation is in the attached letter. Thank you very much for your time.

wichel PLcgwire, RT(R)CNMT NCT Nuclear Medicine SMpewisor stLLtke's Idaho cardiology Assoc. (sLICA)

208-685-2185

vaci.ieLP @idai.ioca vdiolog~f.coPA

1

Re: NRC License #11-27312-01 Amendment Request

Sainual P. Bass, MD, FACC Murdli N. Bathina. MD. FACC Christopher S.Cadiwin. M D,FACC Andrew U. Cliai, MD. FACC Frcderick M. Costello, MD Robert L. Duerr, MD, FACC Charles E. Eiriksson, MD, FACC James C. Field, MD, FACC Stefanie J. Fry, M D, FACC David A. Hinchmx, MD,FACC Brian P Nolan, DO Melinda L. Marks, MD, FACC Marshall F. Priest, MD, FACC Karl P. Undnser, MD, PhD, FACC Anna McCrenth, NP Dana Peachey, NP Shannon Vaughn, NP

Dear Roberto Torres, I am writing to request an expedition on the amendment request previously submitted earlier this

month. I would like to resubmit NRC form 3 13 and the attached documents along with this expedited request based on the following reasons:

Dr Nolan started with our clinic on August 26`h,20 10 and has been seeing patients in clinic since September gth. He has since completed his orientation with our physicians in interpretation of nuclear cardiac studies and is competent in this area.

Since he is also now in the regular rotation for hospital coverage, he would normally be the scheduled physician to interpret all nuclear cardiac studies. Without having him on the NRC license, we have been forced to schedule two physicians on days that he is working just to be able to interpret nuclear studies. Spreading our physicians more thinly this time of year is very difficult because of increased volumes in the clinics and in the hospitals.

Dr Nolan has also completed his CBNC certification exam and is simply waiting to take his cardiology boards in just a few weeks fi-omnow. He will then be promoted to `diplomat' status with the CBNC.

Bringing Dr Nolan to our team. of physicians has been a much needed and welcomed addition. Both he and our established physicians are eager for him to have full cardiology privileges with our hospitals and clinics.

Thank you for your understanding and considering this resubmission for expediting the amendment process. I look forward to hearing from you in the near future.

Rachel Pugmire, RT (R), CNbT, NCT Supervisor, Nuclear Medicine 208-685-21 86 rachelp@

PO Box I 10 -Boise, ID 83701 - (208) 322-1650 - FAX (208) 322-1695 300 E. Jefferson, Suite 101 - Boise, ID 83712 - (208) 336-4141 -FAX (208) 3364035

520 S. Eagle Road. Suite 3 104 - Meridian, ID 83642 - (208) 887-9828 - FAX (208) 884-3096 3 15 E. Elm Strcet. Suite 350- Caldwell, ID 83605 - (208) 454-6363 - FAX (208) 454-3512

1 I Associates

Re: NRC License #I 1-27312-01 Amendment Request

Samual P. Bass, MD, FACC Murali N. Bathina, MD, FACC Christopher S.Cadman, MD, FACC Andrew U. Chai, MD, FACC Frederick M. Costello. MD Robert L. Duerr, MD, FACC Charles E. Eiriksson, MD, FACC James C. Field, MD, FACC Stefanie J. Fry, MD, FACC David A. Hinchman, MD, FACC

iirian F Nolan, DO Melinda L. Marks, MD, FACC

Marshall F. Priest, MD, FACC Karl P. Undesser, MD, PhD, FACC Anna McCreath, NP Dana Peachey, NP Shannon Vaughn, NP

Dear Roberto Torres, I am writing to request an expedition on the amendment request previously submitted earlier this

month. I would like to resubmit NRC form 313 and the attached documents along with this expedited request based on the following reasons:

Dr Nolan started with our clinic on August 26th,2010 and has been seeing patients in clinic since September Sth.He has since completed his orientation with our physicians in interpretation of nuclear cardiac studies and is competent in this area.

Since he is also now in the regular rotation for hospital coverage, he would normally be the scheduled physician to interpret all nuclear cardiac studies. Without having him on the NRC license, we have been forced to schedule two physicians on days that he is working just to be able to interpret nuclear studies. Spreading our physicians more thinly this time of year is very difficult because of increased volumes in the clinics and in the hospitals.

Dr Nolan has also completed his CBNC certification exam and is simply waiting to take his cardiology boards in just a few weeks from now. He will then be promoted to `diplomat' status with the CBNC.

Bringing Dr Nolan to our team of physicians has been a much needed and welcomed addition. Both he and our established physicians are eager for him to have full cardiology privileges with our hospitals and clinics.

Thank you for your understanding and considering this resubmission for expediting the amendment process. I look forward to hearing from you in the near future.

Sincerely,

Rachel Pugmire, RT (R), CNMT, NCT Supervisor, Nuclear Medicine 208-685-2186 rachelp @

PO Box 110 - Boise, ID 83701 - (208) 322-1680 - FAX (208) 322-1695 300 E. Jefferson, Suite 101 -Boise, ID 83712 - (208) 336-4141 -FAX (208) 336-4035 520 S.Eagle Road, Suite 3104 - Meridian, ID 83642 - (208) 887-9828 - FAX (208) 884-3096 3 15 E. Elm Street, Suite 350- Caldwell, ID 83605 - (208) 454-6363 - FAX (208) 454-35 12

NRC FORM 313A (AUD)

(3-2CO7)

U.S. NUCLEAR REGULATORY COMMISSION

AUTHORIZED USER TRAINING AND EXPERIENCE

AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, and 35.500)

[lo CFR 35.190, 35.290, and 35.5901

APPROVED BY OM& NO. 3150-012 EXPIRES: 10/31/2008

I

Name of Proposed Authorized User

State or Territory Where Licensed

Brian P Nolan, DO

Idaho

Requested Authorization(s) (check a//that apply)

35.100 Uptake, dilution, and excretion studies

35.200 Imaging and localization studies

1035.500 Sealed sources for diagnosis (specify device

-

-- 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 obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing

IC]education and experience related to the uses checked above. 1. Board Certification

a. Provide a copy of the board certification

b. If using only 35.500 materials, stop here. If using 35.100 and 35.200 materials, skip to and complete Part I1 Preceptor Attestation.

2. Current 35.390 Authorized User Seekina Additional 35.290 Authorization

a. Authorized user on Materials License

__

State requirements seeking authorization for 35.290.

meeting 10 CFR 35.390 or equivalent Agreement

b. Supervised Work Experience. (If more than one supervising individual is necessary to document supervised wcrk experience, provide multiple

copies of this section.)

Description of Experience

Location of ExperiencelLicense or

Permit Number of Facility

Clock

hours

Dates of Experience*

Eluting generator systems appropriate for the preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs

Total Hours of Experience:

I

Supervising Individual

License/Perrnit Number listing supervising individual as an authonzed user

I I

Supervisor meets the requirements below, or equivalent Agreement State requirements (check a / /that apply).

35.290

c]35.390 + generator experience in 32.290(c)(l)(ii)(G)

I

I

NRC FORM 313A (AUD) (3-2W7)

PRINTED ON RECYCLED PAPER

PAGE 1

JRC FORM 313A (AUD)

U.S. NUCLEAR REGULATORY COMMlSSlOr

EZC07) AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3 3. Training and ExDerience for ProDosed Authorized User

a. Classroom and Laboratory Training

Description of Training

Radiation physics and instrumentation

Location of Training

I

Portland, OR

Clock Hours

Dates of Training*

portionof 80 51612009-

hours

5121 12009

Radiation protection

Portland, OR

--

portion of 80 5l612009-

hours

5121 12009

Mathematics pertaining to the use and measurement of radioactivity

,Portland, OR

Chemistry of byproduct material

for medical use (not required for ' 35.590)

--, - -

'Portland, OR

1

Radiation biology

Portland, OR

portion of 80 ,51612009-

hours

5/2112009

1

-1

portion of 80 151612009-

hours

5/21/2009

1

portion of 80 5/612009-

hours

5121/2009

Total Hours of Training: 80 hours total training

.-

b. Supervised Work Experience (completion of this table Is not required for 35.590). ( I f more than one supervising individual is necessary to document supervised wcrk experience, provide multiple copies of this section.)

Supervised Work Experience

__ Description of Experience Must Include:

Total Hours of 700 hours Experience-: ~

Location of Experience/License or Permit Number of Facility

Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation

3710 S.WA. fUfaSirsVeterans HCoesnpteitar l Road Portland, OR 97239-2964

Yes

surveys

Performing quality control

Veterans Affairs Medical Center

procedures on instruments used to 3710 S.W. US Veterans Hospital Road

Yes

determine the activity of dosages Portland, OR 97239-2964

and performing checks for proper

No

operation of survey meters

Dates of Experience. 7/9/200751612009

719120075/6/2009

PAGE 2

NRC FORM 313A (AUD)

U.S. NUCLEAR REGULATORY COMMISSION

(3-2007) AUTHORIZED USER TWINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

3. Training and Experience for Proaosed Authorized User (continued)

b. Supervised Work Experience. (continued) --

Description of Experience

Location of Experience/License or

Must Include:

Permit Number of Facility

I

1 measuring, and safely

/VeteransAffairs MedicalCenter

3710 S.W. US Veterans Hospital Road

1 preparing patient or human research Portland, OR 97239-2964

' subject dosages

I Dates of

I Experience*

I

719l2007-

1

Yes /5/6/2009

...

.

.i.

I

i

j Administering dosages of radioactive ' ~ ~ ~ ~

drugs to patients or human research Portland, OR 97239-2964

~ Roadw

A

~

v

~

~

~ II~

i

subjects

....

._

...t

..

.......

i~. . . . .

............

.- i

u s j Eluting generator systems appropriateiveterans Affairs Medical Center

ifor the preparationof radioactive

13710 S.W. Veterans Hospital Road

drugs for imaging and localization iPortlanOdR* 97239-2964

:studies, measuring and testing the i

1

l7/9/2007Yes 15/6/2009

I

~

i

i ; U N O ,

j

I eluate for radionuclidic purity, and

I I processing the eluate with reagent

1 kits to prepare labeled radioactive I

drugs

i

!

1

1

I

I

i

i

I

~

I

I

j

~ _..-............

~

4

i Supervising Individual

LicensdPerrnit Number listing supervising individual as an i

authorized user

1 I

Chung Lee, MD

NRC MML 03-23853-OIVA

Supervisor meets the requirements below, or equivalent Agreement State requirements (check one).

I

I

r"] 35.190

35,290

35.390

35.390 + generator experience in 35.290(c)(l)(ii)(G)

I

-- -

-

- __

____ -

- __ -

__ -

I I

- -__

.

c. For 35.590 only, provide documentation of training on use of the device.

- __

- __ -

--

- __

_ _ - ___

Device

__

-

__

Ty_pe

of

Training

__

-I _ _ _

Lo_

ca -

tion ___

and

Dates

I I

I

7 -

1

I

I

_

i

-_

i

I

1

I

-__

-

-

-

- -8

d For 35 500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part I1 Preceptor Attestation.

PAGE 3

JRC FORM 313A (AUD)

US. NUCLEAR REGULATORY COMMISSIOP

3-20071 AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

4 3. Trainina and Experiencefor Proposed Authorized User

a. Classroom and Laboratory Training.

Description of Training

Radiation physics and instrumentation

Location of Training

Portland. OR

Clock

Dates of

Hours , Training'

wrtion of 80 516l2009-

hours

5/21/2009

Radiation protection

Portland, OR

I

-

portion of 80 6/6/2009-

hours

712112009

Mathematics pertaining to the use and measurement of radioactivity

'Portland, OR

Chemistry of byproduct material for medical use (not required for 35.590)

Radiation biology

Portland, OR

Dortland, OR

I

portionof 80 /5/612009-

hours

;5/2112009

I

-

I

I -

7

-

-

-

portionof 80 '5/6/2009-

hours

I

'5/21/2009

I

I

,I -

portion of 80 5/6/2009-

hours

5/21I2009

I

Total Hours of Training: 80 hours total training

b. Supervised Work Experience (completion of this table is not required for 35.590). (If more than one supervising individualis necessary to document supervised wcrk experience, provide multiple copies of this section.)

Supervised Work Experience

,

I Total Hours of 700 hours

Description of Experience , Must Include:

Location of Experience/License or Permit Number of Facility

Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation

Oregon Health Sciences University Division Of Cardiovascular Medicine

Code UHN-62

3181 sw Sam Jackson Park Rd

surveys

.. - . ..

...

Performing quality control

Portland, OR 97239-3098

- . .f

. .

... ... .. .~.

Oregon Health Sciences University

procedures on instruments used to Division Of CardiovascularMedicine

determine the activity of dosages Mail Code UHN-62

and performing checks for proper 3181 SW Sam Jackson Park Rd

operation of survey meters

Portland, OR 97239-3098

'Onfirm

Yes UNO

Dates of Experience*

1711120075/29/2009

,

Yes

a No

711120075/29/2009

-- .

PAGE 2

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