ML18214A429
| ML18214A429 | |
| Person / Time | |
|---|---|
| Site: | 03002146 |
| Issue date: | 08/02/2018 |
| From: | Gryglak M R NRC/RGN-III |
| To: | Smith L T Bronson Methodist Hosp |
| References | |
| 608813 | |
| Download: ML18214A429 (2) | |
Text
8ffieial l:tse 8nly iocuritv Relate&I IRMi'rmatiaR UNITED STATES NUCLEAR REGULATORY COMMISSION REGION Ill 2443 WARRENVILLE RD. SUITE 210 LISLE, IL 60532-4352 AUG O 2 2018 Laura T. Smith, M.S. Radiation Safety Officer Bronson Methodist Hospital 601 John St. Kalamazoo, Ml 49007
Dear Ms. Smith:
Enclosed is Amendment No. 69 to your U.S. Nuclear Regulatory Commission (NRC) Material License No. 21-13125-01 for Bronson Methodist Hospital in accordance with your request dated May 21, 2018. Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region Ill office at (630) 829-9887 so that we may provide appropriate corrections and answers. Please note that, in accordance with your letter dated May 21, 2018, the enclosed amendment has authorized Andrew Forsyth M.D. for the use of yttrium-90 SIR-Spheres microspheres, as permitted by Title 10 ofthe Code of Federal Regulations (CFR) Section 35.1000. The authorization is conditioned on Dr. Forsyth's completion of at least three in vivo SIR-Sphere administrations, while under the supervision of a manufacturer representative.
You will need to notify us in writing, after the cases have been completed, including the date(s) on which cases were complete and the name of the supervising individual.
You will be periodically inspected by NRC. Failure to conduct your program in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in enforcement action against you. The NRC may issue a notice of violation, imposition of a civil penalty, or an order suspending, modifying or revoking your license as specified in the General Statement of Policy and Procedure for NRC Enforcement Actions. Since serious consequences to employees and the public can result from failure to comply with NRC requirements, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary meticulous attention to detail and the high standard of compliance which NRC expects of its licensees.
The NRC's Safety Culture Policy Statement became effective in June 2011. While a policy statement and not a regulation, it sets forth the agency's 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 NRC's 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 enclosed document contains sensitive security-related information.
When separated from this cover letter this letter is uncontrolled.
Qfti1ial l:tse e1119 = Bunuity Relate el h 1fo1 malia ..
Official l:lsc 011IJ ieel!lrity Relatel!I h,tarMatie
.. L. Smith NRC's 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 ADAMS, the NRC's electronic document system. Pursuant to NRC's RIS 2005-31 and in accordance with 10 CFR Section 2.390, the enclosed license document is exempt from public disclosure because its disclosure to unauthorized individuals could present a security vulnerability.
The RIS may be located on the NRC Web site at:
issues/2005/ri200531.pdf and the link for frequently asked questions regarding protection of security-related sensitive information may be located at:
rm/sensitive-info/fag.
htm I. A copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from ADAMS, accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
License No. 24-13125-01 Docket No. 030-02146
Enclosure:
Amendment No. 69 Sincere~ r ~lena R. Gryglak Health Physicist Materials Licensing Branch 8ffieial l:lse O .. IJ ieea1 it, Rclaftffl 11115Pl!.Elisn