ML18227A095

Alaska Heart Institute, LLC; Cover Letter; Amendment 24, License 50-29111-01; Docket 030-34474; Control 609326

ML18227A095
Person / Time
Site:	03034474
Issue date:	08/10/2018
From:	Latischa Hanson NRC Region 4
To:	Skolnick A Alaska Heart Institute, Alaska Heart and Vascular Institute
References
609326
Download: ML18227A095 (4)

See also: IR 05000291/2011001

Text

OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION

UNITED STATES

NUCLEAR REGULATORY COMMISSION

REGION IV

1600 E. LAMAR BLVD

ARLINGTON, TX 76011-4511

August 10, 2018

Alan E. Skolnick, M.D.

Radiation Safety Officer

Alaska Heart Institute, LLC

dba Alaska Heart and Vascular Institute

3841 Piper St, Ste T1-100

Anchorage, AK 99508

SUBJECT: LICENSE AMENDMENT

Dear Dr. Skolnick:

Please find enclosed Amendment No. 24 to NRC License No. 50-29111-01 adding

authorized user, Jacob P. Kelly, M.D., as requested. An environmental assessment for

this licensing action is not required since this action is categorically excluded under 10 CFR 51.22(c)(10)(v), and (14)(iv). You should review this license carefully and be sure

that you understand all conditions. You can contact me at (817) 200-1286 if you have

any questions about this license.

Note that your license and license conditions have been updated in a new format.

Please review your license and notify this office if you have any discrepancies or

questions.

The NRCs Safety Culture Policy Statement became effective in June 2011. While a

policy statement and not a regulation, it sets forth the agencys expectations for

individuals and organizations to establish and maintain a positive safety culture.

You can access the policy statement and supporting material that may benefit your

organization on NRCs safety culture Web site at http://www.nrc.gov/about-

nrc/regulatory/enforcement/safety-culture.html. We strongly encourage you to review

this material and adapt it to your particular needs in order to develop and maintain a

positive safety culture as you engage in NRC-regulated activities.

The enclosure transmitted

herewith contains Official Use

Only - Security-Related

Information. When separated

from this enclosure, this

document is decontrolled.

OFFICIAL USE ONLY - SECURITY-RELATED INFORMATION

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A. Skolnick -2-

NRC expects licensees to conduct their programs with meticulous attention to detail and

a high standard of compliance. Because of the serious consequences to employees and

the public that can result from failure to comply with NRC requirements, you must

conduct your radiation safety program according to the conditions of your NRC license,

representations made in your license application, and NRC regulations. In particular,

note that you must:

1. Operate by NRC regulations 10 CFR Part 19, Notices, Instructions and Reports

to Workers: Inspection and Investigations, 10 CFR Part 20, Standards for

Protection Against Radiation, and other applicable regulations.

2. Notify NRC in writing of any change in mailing address.

3. By 10 CFR 30.36(d) and/or license condition, notify NRC, promptly, in writing,

and request termination of the license:

a. When you decide to terminate all activities involving materials authorized

under the license whether at the entire site or any separate building or

outdoor area;

b. If you decide not to acquire or possess and use authorized material; or

c. When no principal activities under the license have been conducted for a

period of 24 months.

4. In accordance with 10 CFR 35.14, notify the NRC no later than 30 days after:

a. The date that the licensee permits an individual to work as an authorized

user, an authorized nuclear pharmacist or an authorized medical physicist

under 10 CFR 35.13(b)(1) through (b)(4);

b. An authorized user, an authorized nuclear pharmacist, a Radiation Safety

Officer, or an authorized medical physicist permanently discontinues

duties under the license or has a name change;

c. The licensees mailing address changes;

d. The licensees name changes, but the name change does not constitute a

transfer of control of the license as described in 10 CFR 30.34(b); or

e. The licensee has added to or changed the areas of use identified in the

application or on the license where byproduct material is used in

accordance with either 35.100 or 35.200.

5. Request and obtain a license amendment before you:

a. Change Radiation Safety Officers;

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A. Skolnick -3-

b. Order byproduct material in excess of the amount, radionuclide or form

authorized on the license;

c. Add or change the areas or address(es) of use identified in the license

application or on the license, except for areas of use where byproduct

material is used only in accordance with either 10 CFR 35.100 or 35.200;

or

d. Change the name or ownership of your organization.

6. Submit a complete renewal application or termination request at least 30 days

before the expiration date on your license. You will receive a reminder notice

approximately 90 days before the expiration date. Possession of radioactive

material after your license expires is a violation of NRC regulations.

In addition, please note that NRC Form 313 requires the applicant, by signature, to verify

that the applicant understands that all statements contained in the application are true

and correct to the best of the applicants knowledge. The signatory for the application

should be the licensee or certifying official rather than a consultant. Since the NRC also

accepts a letter requesting amendment of an NRC license, the signatory for such a

request should also be the licensee or certifying official rather than a consultant.

NRC will periodically inspect your radiation safety program. Failure to conduct your

program according to NRC regulations, license conditions, and representations made in

your license application and supplemental correspondence with NRC may result in

enforcement action against you. This could include issuance of a notice of violation;

imposition of a civil penalty; or an order suspending, modifying, or revoking your license

as specified in the NRC Enforcement Policy. The NRC Enforcement Policy is available

on the following internet address: http://www.nrc.gov/about-

nrc/regulatory/enforcement/enforce-pol.html.

An electronic version of the NRCs regulations is available on the NRC Web site at

www.nrc.gov. Additional information regarding medical uses of radioactive materials may

be obtained on the NRC Web site at: http://www.nrc.gov/materials/miau/med-use-

toolkit.html . This site also provides the updated Training and Experience NRC Form

313A series of forms and guidance, as well as information on the revised regulations for

naturally-occurring and accelerator-produced radioactive materials (NARM).

The NRC medical list server has been set up. The list server will send automatic e-mail

notifications of medical-related generic communications, Federal Register Notices, and

NMSS/FSME newsletters as they are published. Anyone may subscribe/unsubscribe to

the new medical list server by sending an e-mail to medical-gc@nrc.gov with Subscribe

or Unsubscribe in the subject line.

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A. Skolnick -4-

NRCs Regulatory Issue Summary (RIS) 2005-31 provides criteria to identify security-

related sensitive information and guidance for handling and marking of such documents.

This ensures that potentially sensitive information is not made publicly available through

the NRCs Agencywide Documents Access and Management System (ADAMS). The

RIS may be located on the NRC Web site at: http://www.nrc.gov/reading-rm/doc-

collections/gen-comm/reg-issues/2005/ . Pursuant to NRCs RIS 2005-31, this letter and

its enclosed materials license will not be made publicly available.

Thank you for your cooperation.

Sincerely,

/RA/

Latischa M. Hanson, M.Sc., Health Physicist

Materials Licensing and Inspection Branch

Docket: 030-34474

License: 50-29111-01

Controls: 609326

Enclosure: As stated

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