ML19066A122
| 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: