ML19066A122

Alaska Heart Institute, LLC; Amendment Request; License 50-29111-01; Docket 030-34474; Control 611499

ML19066A122
Person / Time
Site:	03034474
Issue date:	02/05/2019
From:	Skolnick A Alaska Heart Institute, Alaska Heart and Vascular Institute
To:	NRC Region 4
References
611499
Download: ML19066A122 (11)

See also: IR 05000291/2011001

Text

February 5, 2018 ij\E~\EU/\E~ FEB 2 2 2019 DNMS Nuclear Materials

Licensing

Branch U.S. Nuclear Regulatory

Commission, Region IV 1600 E. Lamar Boulevard

Arlington, TX 76011-4511

RE: Amendment

to License# 50-29111-01

Alaska Heart Institute, LLC 3841 Piper St, Suite T-100 Anchorage, AK 99508 We are submitting

a request for an amendment

to license# 50-29111-01.

We would like to add one of our physicians

as Authorized

Users. NRC Form part I and part II of the "Authorized

User Training and Experience

and Preceptor

Attestation" have been completed

and are enclosed with this letter for Carson Webb, MD. Sincerely, Alan Skolnick MD Radiation

Safety Officer Alaska Heart Institute, LLC ENC: NRC Form 313 * NCR Form 313A-Webb CBNC certificate

-Webb PUBLIC IJ Immediate

Release )it.N ormal Release NON-PUBLIC

1J A.3 Sensitive-Security

Related Q A. 7 Sensitive

Internal Q Other:._=-------Reviewer:~ Date: Z-2-6-/9 'ALASKA HEART & VASCULAR INSTITUTE

907. 561. 3211 alaskaheart.com

Ankie Amos, MD. FACC Richard Anschuetz, MD, FACC Krzysztof

Balaban, MD, FACC Mario Binder, MD, FACC David Chambers, MC, FACC Steven Compton, MD, FACC, FACP, FH RS Matthew Corbett, MD,FACC Christopher

Dyke, MD Scott Ebenhoeh, DO John Finley, MD, FACC, FASE Lisa Gray, DO Linda Ireland, DO Jacob Kelly, MD, MHS, FACC Thomas Kramer, MD, FACC Seth Krauss, MD, FACC, FSCAI Mark Levin, MD, MS Peter D. Marbarger, MD Adam Mason, MD, FACC William Mayer, MD, FACC, FACP Jonathan McDonagh, MD Paul Peterson, MD, FACC Gene Quinn, MD, MS,M.P.H.

Brian Scully, MD, FACC Mark Selland, MD, FACC Alan Skolnick, MD, FACC David Sonneborn, MD, FACC Christopher

Thomas, MIJ, FACC Stanley Watkins, MD, MHS, FACC Carson Webb, MD Mark Willcox, MD Yiming Wu, MD, PHD AHVI ANCHORAGE

3841 Piper St. SuiteT-100

Anchorage, AK 99508 ALASKA REGIONAL OFFICE 2751 DeBarr Road Suite B-200 Anchorage, AK 99508 AHVIMAT-SU

2490 S. Woodworth

Loop Suite250 Palmer, AK 99645 AHVI CATH LAB/ACSC 3220 Providence

Dr. Suite E3*063 Anchorage, AK 99508 AHVI SOLDOTNA 240 Hospital Place Suite202 Soldotna, AK 99669 tb6114g 9

NRC FORM 313 (10-2017)

U.S. NUCLEAR REGULATORY

COMMISSION

APPROVED BY 0MB: NO. 3150-0120

EXPIRES: 06/30/2019

10 CFR 30, 32, ~~*""~<< 33, 34, 35, 36, +"' ~"" 37,39,and40

f¥s I. .. " .. \..., Q, -,, "' *it*** APPLICATION

FOR MATERIALS

LICENSE Estimated

burden per response to comply with this mandatory

collection

request: 4.3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />. Submittal

of the application

is necessary

to detenmine

that the applicant

is qualified

and that adequate procedures

exist to protect the public health and safety. Send comments regarding

burden estimate to the lnfonmation

Services Branch (T-2 F43), U.S. Nuclear Regulatory

Commission, Washington, DC 20555-0001, or by e-mail to lnfocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information

and Regulatory

Affairs, NEOB-10202, (3150-0120), Office of Management

and Budget, Washington, DC 20503. If a means used to impose an information

collection

does not display a currently

valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the infonmation

collection.

INSTRUCTIONS:

SEE THE CURRENT VOLUMES OF THE NUREG-1556

TECHNICAL

REPORT SERIES ("CONSOLIDATED

GUIDANCE ABOUT MATERIALS

LICENSES")

FOR DETAILED INSTRUCTIONS

FOR COMPLETING

THIS FORM: 11!1J!:/lwww.nrc.goy/reading-nn/doc-oollectjons/nuregs/stafflsr15561. SEND TWO COPIES OF THE COMPLETED

APPLICATION

TO THE NRC OFFICE SPECIFIED

BELOW. APPLICATION

FOR DISTRIBUTION

OF EXEMPT PRODUCTS FILE APPLICATIONS

WITH: MATERIALS

SAFETY LICENSING

BRANCH DIVISION OF MATERIAL SAFETY, STATE, TRIBAL AND RULEMAKING

PROGRAMS OFFICE OF NUCLEAR MATERIALS

SAFETY AND SAFEGUARDS

U.S. NUCLEAR REGULATORY

COMMISSION

WASHINGTON, DC 20555-0001

ALL OTHER PERSONS FILE APPLICATIONS

AS FOLLOWS: IF YOU ARE LOCATED IN: ALABAMA, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, KENTUCKY, MAINE, MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, NEW YORK, NORTH CAROLINA, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH CAROLINA, TENNESSEE, VERMONT, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA, SEND APPLICATIONS

TO: LICENSING

ASSISTANCE

TEAM DIVISION OF NUCLEAR MATERIALS

SAFETY U.S. NUCLEAR REGULATORY

COMMISSION, REGION I 2100 RENAISSANCE

BOULEVARD, SUITE 100 KING OF PRUSSIA, PA 19406-2713

IF YOU ARE LOCATED IN: ILLINOIS, IN DIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN, SEND APPLICATIONS

TO: MATERIALS

LICENSING

BRANCH U.S. NUCLEAR REGULATORY

COMMISSION, REGION Ill 2443 WARRENVILLE

ROAD, SUITE 210 LISLE, IL 60532-4352

IF YOU ARE LOCATED IN: ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, HAWAII, IDAHO, KANSAS, LOUISIANA, MISSISSIPPI, MONTANA, NEBRASKA, NEVADA, NEW MEXICO, NORTH DAKOTA, OKLAHOMA, OREGON, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS, UTAH, WASHINGTON, OR WYOMING, SEND APPLICATIONS

TO: NUCLEAR MATERIALS

LICENSING

BRANCH U.S. NUCLEAR REGULATORY

COMMISSION, REGION IV 1600 E. LAMAR BOULEVARD

ARLINGTON, TX 76011-4511

PERSONS L OCATED IN AGREEMENT

STATES SEND APPLICATIONS

TO THE U.S. NUCLEAR REGULATORY

COMMISSION

ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO U.S. NUCLEAR REGULATORY

COMMISSION

JURISDICTIONS.

1. THIS IS AN APPLICATION

FOR (Check appropriate

item) D A. NEW LICENSE 0 B. AMENDMENT

TO LICENSE NUMBER 50-29111-01

D C. RENEWAL OF LICENSE NUMBER 3. ADDRESS WHERE LICENSED MATERIALS

WILL BE USED OR POSSESSED

3841 Piper Street Suite TLL-10 Anchorage, AK 99508 2. NAME AND MAILING ADDRESS OF APPLICANT (Include zip code) Alaska Heart Institute

3841 Piper Street, Suite T-100 Anchorage, AK 99508 4. NAME OF PERSON TO BE CONTACTED

ABOUT THIS APPLICATION

Cathy McVey BUSINESS TELEPHONE

NUMBER 907 -550-2273

BUSINESS E-MAIL ADDRESS cmcvey@alaskaheart.com

I BUSINESS CELLULAR TELEPHONE

NUMBER SUBMIT ITEMS 5 THROUGH 11 ON 8-112 X 11" PAPER. THE TYPE AND SCOPE OF INFORMATION

TO BE PROVIDED IS DESCRIBED

IN THE LICENSE APPLICATION

GUIDE. 5. RADIOACTIVE

MATERIAL 6. PURPOSE(S)

FOR WHICH LICENSED MATERIAL WILL BE USED. a. Element and mass number; b. chemical and/or physical form; and c. maximum amount which will be possessed

at any one time. 7. INDIVIDUAL(S)

RESPONSIBLE

FOR RADIATION

SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE.

8. TRAINING FOR INDIVIDUALS

WORKING IN OR FREQUENTING

RESTRICTED

AREAS. 9. FACILITIES

AND EQUIPMENT.

10. RADIATION

SAFETY PROGRAM. 11. WASTE MANAGEMENT. (See 10 CFR 170 and Section 170.31) CA,!;,~~RY

12. LICENSE FEES (Fees required only for new applications, with few exceptions')

I 'Amendments/Renewals

that Increase the scope of the existing license to a new or higher fee category will require a fee. I AMOUNT $1 ENCLOSED PER THE DEBT COLLECTION

IMPROVEMENT

ACT OF 1996 (PUBLIC LAW 104-134), YOU ARE REQUIRED TO PROVIDE YOUR TAXPAYER IDENTIFICATION

NUMBER. PROVIDE THIS INFORMATION

BY COMPLETING

NRC FORM 531: !!!!Pgfwww.nrc,.gov/readin.9-rm1f!oc-collections/fonns/nrc531info.btrnJ. 13. CERTIFICATION. (Must be completed

by applicant)

THE APPLICANT

UNDERSTANDS

THAT ALL STATEMENTS

AND REPRESENTATIONS

MADE IN THIS APPL/CATION

ARE BINDING UPON THE APPLICANT.

THE APPLICANT

AND ANY OFFICIAL EXECUTING

THIS CERTIFICATION

ON BEHALF OF THE APPLICANT, NAMED IN ITEM 2, CERTIFY THAT THIS APPLICATION

IS PREPARED IN CONFORMITY

WITH TITLE 10, CODE OF FEDERAL REGULATIONS, PARTS 30, 32, 33, 34, 35, 36, 37, 39, AND 40, AND THAT ALL INFORMATION

CONTAINED

HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE

AND BELIEF. WARNING: 18 U.S.C. SECTION 1001 ACT OF JUNE 25, 1948 62 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY

FALSE STATEMENT

OR REPRESENTATION

TO ANY DEPARTMENT

OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISDICTION.

-* // / CERTIFYING

OFFICER --TYPED/PRINTED

NAME AND TITLE Alan Skolnick, MD FOR NRC USE ONLY TYPE OF FEE I FEE LOG I FEE CATEGORY I $ AMOUNT RECEIVED CHECK NUMBER COMMENTS APPROVED BY DATE NRC FORM 313 (10-2017)

NRC FORM 313A (AUD) (06-2016)

U.S. NUCLEAR REGULATORY

COMMISSION

AUTHORIZED

USER TRAINING AND EXPERIENCE

AND PRECEPTOR

ATTESTATION

APPROVED BY 0MB: NO. 3150-0120

EXPIRES: 06/30/2019 (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.190, 35.290, and 35.590] Name of Proposed Authorized

User CARSON WEBB, MD Requested

Authorization(s) (check all that apply) 0 35.100 Uptake, dilution, and excretion

studies 0 35.200 Imaging and localization

studies D 35.500 Sealed sources for diagnosis (specify device) State or Territory

Where Licensed ALASKA 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

education

and experience

related to the uses checked above. 0 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 II Preceptor

Attestation.

D 2. Current 35.390 Authorized

User Seekin g Additional

35.290 Authorization

a. Authorized

user on Materials

License meeting 10 CFR 35.390 or equivalent

Agreement

---

State requirements

seeking authorization

for 35.290. b. Supervised

Work Experience. (If more than one supervising

individual

is necessary

to document supervised

work experience, provide multiple copies of this section.)

Description

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 Supervising

Individual

Location of Experience/License

or Permit Number of Facility Total Hours of Experience:

Clock Hours Dates of Experience*

License/Permit

Number listing supervising

individual

as an authorized

user Supervisor

meets the requirements

below, or equivalent

Agreement

State requirements (check all that apply). D 3s.290 D 35.390 + generator

experience

in 32.290(c)(1

)(ii)(G) NRC FORM 313A (AUD) (06-2016)

PAGE 1

NRC FORM 313A (AUD) U.S. NUCLEAR REGULATORY

COMMISSION

<05-2015> AUTHORIZED

USER TRAINING AND EXPERIENCE

AND PRECEPTOR

ATTESTATION (continued)

D 3. Trainin g and Ex p erience for Pro p osed Authorized

User a. Classroom

and Laboratory

Training.

Description

of Training Radiation

physics and instrumentation

Radiation

protection

Mathematics

pertaining

to the use and measurement

of radioactivity

Chemistry

of byproduct

material for medical use (not required for 35.590) Radiation

biology Location of Training Total Hours of Training:

b. Supervised

Work Experience (completion

of this table is not required for 35_590). Clock Hours (If more than one supeNising

individual

is necessary

to document supeNised

work experience, provide multiple copies of this section.)

Supervised

Work Experience

Description

of Experience

Must Include: Ordering, receiving, and unpacking

radioactive

materials

safely and performing

the related radiation

surveys Performing

quality control procedures

on instruments

used to determine

the activity of dosages and performing

checks for proper operation

of survey meters NRC FORM 3 1 3 A (AUD) (06-2016)

Total Hours of Experience:

Location of Experience/License

or Permit Number of Facility Confirm 0 Yes ONo D Yes D No >> (' 1 Dates of Training* Dates of Experience*

P A GE2 C

NRC FORM 313A (AUD) U.S. NUCLEAR REGULATORY

COMMISSION (o 6-2016 l AUTHORIZED

USER TRAINING AND EXPERIENCE

AND PRECEPTOR

ATTESTATION (continued)

3. Trainin g and Ex p erience for Pro p osed Authorized

User (continued)

b. Supervised

Work Experience. (continued)

Description

of Experience

Must Include: Location of Experience/License

or Permit Number of Facility Confirm Dates of Experience*

Calculating, measuring, and safely preparing

patient or human research subject dosages Using administrative

controls to prevent a medical event involving

the use of unsealed byproduct

material Using procedures

to contain spilled byproduct

material safely and using proper decontamination

procedures

Administering

dosages of radioactive

drugs to patients or human research subjects 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 Supervising

Individual

0Yes ONo o ves D No OYes D No D Yes D No 0 Yes ONo License/Permit

Number listing supervising

individual

as an authorized

user Supervisor

meets the requirements

below, or equivalent

Agreement

State requirements (check one). D 35.190 D 35.290 D 35.390 D 35.390 + generator

experience

in 35.290(c)(1)(ii)(G)

c. For 35.590 only, provide documentation

of training on use of the device. Device Type of Training Location and Dates &.61149 9 d. For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor

Attestation.

NRC FORM 313A(AUD)

(06-2016)

PAGE3

NRC FORM 313A (AUD) U.S. NUCLEAR REGULATORY

COMMISSION (o6-2016 l AUTHORIZED

USER TRAINING AND EXPERIENCE

AND PRECEPTOR

ATTESTATION (continued)

PART 11-PRECEPTOR

ATTESTATION

Note: This part must be completed

by the individual's

preceptor.

The preceptor

does not have to be the supervising

individual

as long as the preceptor

provides, directs, or verifies training and experience

required.

If more than one preceptor

is necessary

to document experience, obtain a separate preceptor

statement

from each. (Not required to meet training requirements

in 35.590) By checking the boxes below, the preceptor

is attesting

that the individual

has knowledge

to fulfill the duties of the position sought and not attesting

to the individual's "general clinical competency." First Section Check one of the following

for each use requested:

For 35.190 Board Certification

0 1 attest that CARSON WEBB, MD has satisfactorily

completed

the requirements

in Name of Proposed Authorized

User 10 CFR 35.190(a)(1)

and has achieved a level of competency

sufficient

to function independently

as an authorized

user for the medical uses authorized

under 10 CFR 35.100. OR Trainin g and Ex p erience D I attest that has satisfactorily

completed

the 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of training and Name of Proposed Authorized

User experience, including

a minimum of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom

and laboratory

training, required by 10 CFR 35.190(c)(1

), and has achieved a level of competency

sufficient

to function independently

as an authorized

user for the medical uses authorized

under 10 CFR 35.100. For 35.290 Board Certification

D I attest that has satisfactorily

completed

the requirements

in Name of Proposed Authorized

User 1 O CFR 35.290(a)(1)

and has achieved a level of competency

sufficient

to function independently

as an authorized

user for the medical uses authorized

under 10 CFR 35.100 and 35.200. Trainin g and Ex p erience D I attest that Name of Proposed Authorized

User OR has satisfactorily

completed

the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, including

a minimum of 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom

and laboratory

training, required by 10 CFR 35.290(c)(1

), and has achieved a level of competency

sufficient

to function independently

as an authorized

user for the medical uses authorized

under 10 CFR 35.100 and 35.200. *****------------------*************************************************************************-------*****--*

Second Section Complete the following

for preceptor

attestation

and signature:

0 I meet the requirements

below, or equivalent

Agreement

State requirements, as an authorized

user for: 0 35.190 Name of Preceptor

ALAN SKOLNICK, MD 0 35.290 License/Permit

Number/Facility

Name 50-29111-01/ALASKA

HEART rNSTITUTE

NRC FORM 313A (AUD) (06-2016)

D 35.3so D 35.390 + generator

experience

Telephone

Number (907) 561-3211 Date 2/5/2019 PAGE 4

co .-.. t\t.Jr-30.*on."Boctt.d of Nuclear Cg**d* .1. 5 * , * Incorporated

1996 q.a. I 10.(~ * * . Part af lhe Alliance l'crPhysitfan

Certification

&Advancemen!"'

Medk:al Spedalty Boards and Certification

programs 0~ Certifies

That Carson S. fil"ebb!J

MD HAVING MET 'IHE RECERTIFICATION

REQUIREMENTS

PRESCRIBED

BY THIS BOARD AND HAVING SATISFACTORILY

PASSED TIIE REQUIRED EXAMINATION, IS HEREBY DESIGNATED

A DIPLOMATE

CERTIFIED

IN TIIE SUBSPECIALTY

OF NUCLEAR CARDIOLOGY

1r-Chairman Vice-Chairman

CERTIFICATE

NUMBER: 5878

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NRC FORM 532 U.S. NUCLEAR REGULATORY

COMMISSION

(05-2016)

aP"WIIEGJ(I<-.

~* \ ll ACKNOWLEDGEMENT

-RECEIPT OF CORRESPONDENCE . e "' l .. ,. ...... Name and Address of Applicant

and/or Licensee Date I 03/05/2019

I Alan E. Skolnick, M.D. License Number (s) Radiation

Safety Officer I 50-29111-01

I Alaska Heart Institute, LLC dba Alaska Heart and Vascular Institute

Mail Control Number (s) 3841 Piper St, Ste T1-100 I 611499 I Anchorage, AK 99508 Licensin g and/or Technical

Reviewer or Branch C. Hill This is to acknowledge

receipt of your: 0 Letter and/or D Application

Dated: 02/05/2019

The initial processing, which included an administrative

review, has been performed.

0 Amendment

D Termination

D New License D Renewal D There were no administrative

omissions

identified

during our initial review. D This is to acknowledge

receipt of your application

for renewal of the material(s)

license identified

above. Your application

is deemed timely filed, and accordingly, the license will not expire until final action has been taken by this office. D Your application

for a new NRC license did not include your taxpayer identification

number. Please complete and submit NRC Form 531, Request for Taxpayer Identification

Number, located at the following

link: htt g ://www.nrc.

g ov/read in g-rm/doc-col

lections/f

orms/nrc531.

g df Follow the instructions

on the form for submission.

D The following

administrative

omissions

have been identified:

Your application

has been assigned the above listed MAIL CONTROL NUMBER. When calling to inquire about this action, please refer to this control number. Your application

has been forwarded

to a technical

reviewer.

Please note that the technical

review, which is normally completed

within 180 days for a renewal application

(90 days for all other requests), may identify additional

omissions

or require additional

information.

If you have any questions

concerning

the processing

of your application, our contact information

is listed below: Region IV U. S. Nuclear Regulatory

Commission

DNMS/NMSB

-B 1600 E. Lamar Boulevard

Arlington, TX 76011-4511

(817) 200-1103 or (817) 200-1140 NRG FORM 532 (05-2016)

BETWEEN: Accounts Receivable/Payable

and Regional Licensing

Branches [ FOR ARPS USE ] INFORMATION

FROM WBL Program Code: 02201 Status Code: Pending Amendment

Fee Category: 7C Exp. Date: 09/30/2022

Fee Comments: Decom Fin Assur Reqd: N License Fee Worksheet

-License Fee Transmittal

= A. REGION 1. APPLICATION

ATTACHED Applicant/Licensee

Alaska Heart Institute, LLC Received Date: 02/22/2019

Docket Number: 3034474 Mail Control Number: 611499 License Number: 50-29111-01

Action Type: Amendment

2. FEE ATTACHED Amount: Check No.: 3. COMMENTS Signed: Date: B. LICENSE FEE MANAGEMENT

BRANCH (Check when milestone

03 is entered / / 1. Fee Category and Amount: ------------------

2. Correct Fee Paid. Application

may be processed

for: Amendment:

Renewal: License: Signed: Date: